THE POWER OF COMMUNICATION

Standard Operating Procedure (SOP) submission of research proposal

2012-02-10T07:48:00.000-08:00

1. All research projects (Clinical studies, drug trial, trials of medical devices) shall first be submitted to the Research committee for evaluation of scientific content and study design.

1.1.The research committee shall meet once a month. Their responsibilities will include:

A) Evaluation of all new projects

B) Help investigators in improving the study design

C) Monitor the progress of the ongoing research projects. This will be by a progress report to be submitted by the investigators every 6 months.

1.2. The Research Committee shall communicate its decision on a new proposal

(Approval or rejection) within 3 weeks of submission.

1.3 All drug trials (including post-marketing surveillance studies) or trials of
medical devices, all such proposals shall necessarily be submitted to Ethics
Committee for approval before the trial is initiated.

2.1. Submission of application to Ethics Committee: The investigator is expected to

Submit a complete set of documents to the Ethics Committee (15 copies should be submitted).Incomplete applications will not be accepted. Investigators may take the assistance of the Secretary, Ethics Committee in this regard. All proposals should be submitted at least three weeks beforehand for consideration in the committee meeting .The documents required to be submitted include:

1. A brief statement of the objectives and rationale for undertaking the study and the existing knowledge on the subject. The statement must briefly outline the study design and methodology; subject recruitment procedures; inclusion and exclusion criteria and safety or risk factors associated with the study.

2. A complete investigation protocol giving details of the protocol title, identification number and date (including all amendments with date), name of CRO, name of principal investigator must be submitted. The protocol must include a complete investigator brochure including the details of the drug/device under study, study design, randomization procedure, inclusion / exclusion criteria, handling of products, assessment of efficacy, assessment of safety, statistical methods etc.

3. All necessary documents showing that the appropriate regulatory clearances have been taken must be enclosed. All drug trials must have prior DCGI clearance.

4. The method of taking informed consent must be clearly defined. A copy of the informed consent form (in at least two languages, English & vernacular must be included.

5. All financial aspects of the study must be clearly enclosed. This should include information about the sources of economic support, payment to subjects, payments to the investigator or other members of the research team. A statement on conflict of interests, if any, must be included.

6. A publication policy should be clearly defined. This should include plan for publication of results-positive or negative, while maintaining the privacy and confidentiality of the study participant.

7. The investigator must submit an unequivocal undertaking from the sponsor of the proposed compensation and reimbursement in case of study-related injury, disability or death. The sponsor shall indemnify the investigator and the institution against such mishaps and adequately compensate the subject. In case of insurance cover a copy of the same must be included.

8. The principal investigator shall ensure that the identity and data of patients remains private and confidential.

2.2. The investigator is obliged to inform the Ethics Committee immediately of the
following

1. Any amendment of the study protocol

2. Any adverse event relating to the study in the institution concerned, or in any other center, in cases of a multi-center trial.

3. Premature termination of the study, and reasons thereof

2.3.The Principal Investigator shall not recruit any subjects in the trial till the Ethics Committee approval has been obtained.

2.4.Upon completion of the trial the Principal Investigator must submit a conclusion report to the Ethics Committee within four weeks of completion.

2.5.The investigator must submit a statement agreeing to comply with the national and international GCP protocols for clinical trials, and the guidelines of the national regulatory bodies.

2.6.The Ethics Committee shall undertake to communicate to the investigator its decision on the submitted proposal not later than 2 months from the time of submission. The Ethics Committee shall not give conditional approvals. The onus of providing the necessary explanations to queries raised by the Ethics Committee shall rest with the investigator and the sponsor of the study .

2.7.The Ethics Committee shall operates in accordance with the Indian Council of Medical Research guidelines and International Conference on Hormonisation of technical requirements for registration of pharmaceuticals for human use and Good Clinical Practice (ICH-GCP)/Declaration of Helsinki (amendments) guidelines.

2.8.The Ethics Committee shall meet once in a month. The quorum of the meeting shall consist of at least five members present.

2.9.Incase the Chairman is unable to attend the meeting, a non-institutional Member may be requested to take the chair.

2.10. The Hospital shall charge 10% of the total financial budget as an administrative fee

Essential Documents....

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ESSENTIAL TRIAL DOCUMENTS IN CLINICAL TRIAL

Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced(ICH GCP)

The training on essential documents is must in order to generate good quality scientific data. The essential trail documents includes-

Protocol
ICD
CRF
IB
Investigator Master File & other necessary documents
Signed protocol and amendments.

An organized work will make your life easy..............

2012-01-13T10:18:00.000-08:00

Clinical trial business development

Protocol formation

Investigator identification and recruitment

Investigator meetings

IRB assistance

Third party vendor management

Site Master File maintenance

Site regulatory document control

Site feasibility

Interim monitoring

Site training

Safety monitoring

SAE database

SAE reporting

Annual safety reporting

Site closeouts

SITE INITIATION IN CLINICAL TRIAL

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SITE INITIATION

Site initiation refers to the process of assessing the readiness of an investigator site for initiating the enrolment in a clinical trial.

Site initiation visit is performed after the ethics committee approval and prior to first patient visit to ensure that the investigator and the site personnel are trained on various clinical trial responsibilities which includes:-

Ø Essential Trial Documents

Ø Roles & Responsibilities/Delegations

Ø Facility

Ø Informed consent Process

Ø SAE process

Ø Study drug & Accountability

Ø Source Documents

Ø Randomization Procedure

Ø Data Management

Ø Role of Sponsor

Ø Study Timelines

Ø Audits/Inspections

Ø Archival

Reference.

http://blog.gobalto.com/

CASE REPORT FORM IN CLINICAL TRIAL

2012-01-08T07:55:00.000-08:00

Case Report Form (CRF)

A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.

Purpose of CRF

Collects relevant data in a specific format in accordance with the protocol and compliance with regulatory requirements

Allows for efficient and complete data processing,analysis and reporting

Facilitates the exchange of data across projects and organizations.

Elements Of CRF

HEADER :-It must have study number,subject identification code and center number
SAFETY RELATED MODULES:-It includes adverse events,patient physical exams,vital signs,concomitant medication and patient symptoms.
EFFICACY RELATED MODULES:-Define diagnostics required include appropriate baseline measurements,identify key efficacy endpoints and additional tests for efficacy

ELEMETNS OF THE CRF

Three major parts:

Header

Safety related modules

Efficacy related modules

The power of communication

2012-01-06T09:16:00.000-08:00

I am very thankful to all of my readers.Today i just crossed my 60th days of blogging.I received a lot of appreciation from my friends and family members regarding to the quality i maintain on each writing.I keep appreciate your comments and views related to my blogs.As everyone knows i am not well experienced in blogging however i do my level best to update my knowledge and ideas to produce quality blogs in future.I hope you people still having a new year hangover.So once again i wish you a HAPPY NEW YEAR 2012 to everyone.

Thanks
Pearl oyster
www.englishtest0.blogspot.com

MONITORING IN CLINICAL RESEARCH

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The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s)(ICH-GCP).

IMPORTANT TASKS...

1. Verifying that source documents and other trial records are accurate, complete, kept up-to-date and maintained

2. Checks that the laboratory reports have been reviewed, commented upon, signed and dated

3. Discusses and documents any issues related to IP storage, records, reconciliation, expiration dates, etc. Confirms whether sufficient IP is present at site

4. Ensures all safety related data has been captured (SAEs, ADRs, etc)

5. Determining whether the investigator is maintaining the essential documents.

6. Check the informed consent was taken and the process documented per requirements

7. Inspects storage conditions of laboratory kits, biological samples, etc

8. Reviews if all procedures were conducted as per the protocol & regulatory guidelines

9. Review site master file.

10. Ensure the whole IRB/ IEC notification/ submissions are filed according to the guidelines.

11. Communicate with study investigator regarding to the study progress and resolve any queries related to the study.

12. Answers any study related or protocol related questions from study staff

13. Completes a Site Visit Log

14. Checks randomization & emergency procedures are appropriate and are documented correctly

15. All withdrawals and dropouts of enrolled subjects from the trial are reported and explained on the CRFs.

MONITOR

A monitor (CRA) is a person who is appointed from the sponsor to review all study related activities. She/he can act as the main line of communication between the sponsor and the investigator. The necessary skills include confidence, good interpersonal relationship, eye for detail, communication, flexibility, initiative, time management, adherence to commitments, problem solving ability, and adaptability to changing environment are the key things to perform well in this role.

CLINICAL INSPECTION

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What is Inspection?

“The act by a regulatory of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority to be related to the clinical trial and that may be located at the Site of the trial,Sponsor’s and/or CRO’s facilities,Other establishments deemed appropriate by the regulatory authority”(ICH-GCP Sec 1.29)

Why inspection is inevitable?

During ongoing clinical trials to provide real-time assessment of the investigator’s conduct of the trial and protection of human subjects.In connection with a clinical study, An inspection may be undertaken if there are concerns about its safety, data or ethics,monitor standards of clinical research,when there is suspicion of fraud or scientific misconduct or serious quality systems breakdown.

Types of inspections

1.Routine surveillance-It occurs after premarket approval/NDA submitted.

2.For cause-Find any suspicion of fraud,complaints and termination of the site.

For more about clinical research visit:www.englishtest0.blogspot.com

CLINICAL AUDITOR

2012-01-04T09:15:00.000-08:00

What is a Audit?

A Systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted and the data were recorded, analysed and accurately reported according to the Protocol,Sponsor’s SOP,Good Clinical Practice and Applicable Regulatory requirement (ICH-GCP Sec 1.6)

Who can Audit a clinical trial?

The audit can be conducted by FDA,Department of health and Human Services,The Sponsor of the clinical trial,Cooperative Group,IRBs and Institutions

What can be audited?

1. Regulatory and protocol compliance
2. Subject Records and Informed Consent
3. Investigational Product and Lab Tests/Study Procedures
4. Data Management Assessment,Adverse events, SAEs or complications
5. Documentation.

Different types of audit?

1.Study-oriented Inspection-It is ensure that a site is complying with Protocol, SOP, GCP and Applicable regulatory requirements.This is also referred as “ROUTINE AUDIT.

2.Investigator-oriented Inspection-The audit will do if the site is out of compliance and the sponsors want to either verify the problem or be reassured that no problem exists.

Who can be a perfect auditor?

Those who are capable to perform the following functions and responsibilities accurately:-

· Producing protocol statistical reports

· Coordinating Clinical Investigation Leadership Committee and Audit Committee meetings

· Implementing policies as needed for the clinical trial process

· Coordinating the Multi-Center Coordinating Committee

· Prospectively registering all protocol subjects, including consent and eligibility verification

· Monitoring protocol accrual

· Assisting investigators with external audits

· Participating in clinical trials process training

RESPONSIBILITIES OF CLINICAL RESEARCH COORDINATOR

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Who Can Be A Real Clinical Research Coordinator?

1.IRB Submission:Clinical research coordinator has to submit all essential documents for IRB review with the cooperation of investigator.

2.Patient Screening and Study Document Maintenance:The study coordinator is responsible for the initial screening of the Study Participant and study documents maintenance.The main responsibilities include- On-site pre-screen visit with the subject. Any documentation generated from this process must be documented and screening log is filled by the study coordinator/ research assistant. The study coordinator/research assistant will perform assigned duties related to the study such as documenting vital signs, drug accountability, Collection of blood samples, obtaining urine samples, monitoring adverse events, shipping laboratory samples, performing ECG’s, Scheduling a next visit to the subject and patient follow -up.

3.Patient Recruitment:Study coordinators/Research Assistants are responsible for assisting in recruiting and enrolling patients into clinical trials . Recruitment of patients may be performed via- IRB approved advertising,Phone interviews. Clinician referrals ,Posting of fliers and Chart review.

4.Communicate with Sponsor and Regulatory:The study coordinator will also be responsible for interacting with sponsor and regulatory regarding to any study related queries.

5.Miscellaneous:

Monitoring that the research follows proper clinical practices and the maintenance of accurate protocol.
Verify that the documentation of the informed consent process for each study subject is accurate and periodic.
See that all the adverse experiences are correctly reported and documented
Check the completeness and accuracy of the case report.
Try to increase the uses and the efficiency of clinical documentation.

INFLUENCES OF PHARMACOVIGILANCE IN PATIENT SAFETY

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The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem - WHO

What are main aims of pharmacovigilance ?

To improve patient care and safety

To improve public health and safety

To contribute to the assessment of benefit, harm, effectiveness and risk of medicines

To promote understanding, education and clinical training

How it influences on patient safety?

Increased awareness and interest amongst doctors and pharmacists to report ADRS as they have seen some benefit in reporting

GCP training for investigators served to increase awareness of SAE and ADR reporting amongst health care professionals and the industry

More hospitals and companies using on-line reporting system – less hassle than submitting hard copy reports

Increasing involvement by hospital pharmacists in pharmacovigilance – during clinical ward rounds and when counseling patients

Who are the organizers in Pharmacovilance?

Government

Industry

Hospitals and academia

Medical and pharmaceutical associations

Poisons information centres

Health professionals

Patients

Consumers

Media

WHO

BENEFITS & CHALLENGES OF INFORMED CONSENT PROCESS

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INFORMED CONSENT

A document that describes the rights of the study participants, and includes details about the study, such as its purpose, duration, required procedures, key contacts, risks and potential benefits of the clinical research study.

CHALLENGES

Lack of training &shortage of trainers.
Renewal & re consultation of Informed consent
Inadequate information in the informed consent.
Poor communication & lack of vigilance during the informed consent process.

BENEFITS

Patient should have an opportunity to ask questions to elicit a better understanding of the treatment or procedure.
Patient will be safe in legally.

STAKE HOLDERS AND THEIR ROLES IN CLINICAL RESEARCH

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Sponsor (Initiator)-It is an individual or organization provide support for financing,management and initiation of clinical study.

Investigator(The Researcher)-He/She is the team leader of the clinical trial.The prime responsibilities include regulatory submission,patient counseling and study coordination.

Regulatory(The Enforcer)-Regulatory must keep on eye on the study whether it complies all regulatory requirements or not

EC (Safety Squad)-Ethics committee reviews all essential documents provided by study site and evaluate the quality of study.

Study Subject-Study subject must obey all protocol requirements and cooperate with study site for the success of the trial.

CRA (Monitors)-They recruited by sponsor to evaluate study and train other research team for the success of the study.

CRC-They act as a bridge between sponsor and investigator for the coordination of the trial.

CLINICAL RESEARCH

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What is Clinical research?

Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy.

How clinical research benefits to society?

1.Knowledge transfer-It is the exploitation of the research findings for the benefits of the economy,environment and quality of life.

2.Improve health services-By the advent of sophisticated technology enhances the life style in a large extent.Eg-Medical imaging technologies and the use of Antithrombotics to prevent heart attacks and strokes.

PREPARATION OF HA/POLYMER BLENDS

2011-12-04T05:04:00.000-08:00

PREPARATION OF HA/POLYMER BLENDS

MATERIALS

The materials used for the scaffold preparation are polymers like PBMA and PEVA, hydroxyl apatite and mannitol.PBMA was supplied by sigma Aldrich (St .Louis, USA), PEVA was supplied by Phoquse Pharmaceuticals limited.Hydroxy apatite by Riedel-de Haen (Germany) Mannitol was provided by Fisher Scientific (Leicestershire, UK).

PREPARATION

The method used here for the fabrication of the scaffold is conventional particulate leaching method. Two type of polymers are used for this purpose was polybutyl methacrylate (PBMA) and poly ethylene co vinyl acetate (PEVA).Accurately weighed PEVA and PBMA dissolved in 3ml of chloroform solution at 50°C and add hydroxyl apatite and mannitol into the polymer solution. Stir the sample at 50°C under 300 rpm.for 30 min.Continue stirring another 30 min without heating until it reaches room temperature.

Add 0.4 ml of sample into the tissue mould and allow for solidification at 30°C under oven for 1 day. The prepared disc immersed into the 1 litter of distilled water under magnetic stirring for 24 hrs.It can be dried under room temperature .Different samples are prepared by using altering the amount of polymers and mannitol.Total 5 samples prepared.All samples are prepared by combination of PEVA and PBMA using varying amount.

Method-2

In second method, the amount of chloroform used will change. The first 3 samples can be dissolving in 5 ml of chloroform and rest of 2 samples can dissolve in 12 ml of chloroform. The rest of the procedures same as above.

Method-3

In this method, again change the amount of chloroform used. The first 3 samples can dissolve 4 ml of chloroform and the rest of the 2 samples dissolved in 8 ml of chloroform. Prepared discs have to keep at 70°C under oven for 1 day.

Method-4

Dissolve the polymer amount in 4 ml (for all samples )of chloroform at 50°C.Add the amount of HA and mannitol under magnetic stirring (300rpm).Stir the above sample for 30 minutes use magnetic stirrer. Continue stirring for another 30 minutes without heating until they reach room temperature.Then put the glass vial into the sonication bath for 10 minutes. Add 0.4 ml in the plastic moulds and then put it into the oven at 30°C for 1 day until the solvent is completely remove from the moulds.

CHARACTERISTICS OF HYDROXY APATITE /POLYMER BLENDS

2011-12-03T01:27:00.000-08:00

CHARACTERISTICS OF HYDROXY APATITE /POLYMER BLENDS

The hydroxyl apatite /polymer blends have some specific properties for the maximum cell growth. They are

Biocompatibility

The scaffold used for the tissue transplantation must be biocompatible. There are many factors which influence implant biocompatibility such as implant size, shape, material composition, surface wettability and roughness.

Scaffold should not produce any toxic effect to host cells or tissues. Any adverse reaction may cause to minimise the functions of body and produce inflammation. So, implantable material should not -

Cause thrombus formations.
Produce any carcinogenic effect
Alter plasma proteins and enzymes in the body
Produce any toxic or allergic reactions
Destroy or sensitize the cellular elements of the blood
Cause teratological effect
Produce immunogenic and mutagenic effect

Osteoconductivity

The scaffold must have good pore size and surface property for the growth of osteoblast cells on the surface.Osteoconductivity is a passive process which enhances bone growth.

Interconnected porosity

It provides a high void volume for vascularisation and nutrient diffusion. It is necessary to promote cell adhesion.

Desirable mechanical integrity.

Polymers provide high mechanical integrity to scaffold. It helps to maintain predesigned tissue structure.

Ability to deliver inductive factors

Bone formation is complex process that involves a large number of hormones, cytokines, and growth factors. Growth factors are the osteoinductive molecules which speed up tissue growth and bone healing. They are:-

Bone morphogenic protein (BMP)-it helps to direct endochondral ossification and chondrogenesis of mesenchymal stem cells. Recent studies revealed that BMP-2, BMP-4 and BMP-7 have strong efficacy in inducing bone formation.
Transforming growth factor (TGF-B)-it mediates multiple biological functions of fractured bones. Mainly, it enhances the proliferation and recruitment of mesenchymal cells and ECM production.
Basic fibroblastic growth factor (b FGF) - it acts as a stimulant for bone healing.Moreover,the strong potency of this growth factor results to regulation of cell proliferation and increase in osteblastic bone remodelling.

Vascular endothelial growth factor (VEGF) - the blood vessels within bone plays an important role in the transport of nutrients and circulating paracrine factors. It stimulates proliferation and migration of endothelial cells in bone tissue. However, the main function of VEGF is related to nutrient transportation, it also implicated in recruitment, survival, and activity of bone forming cells. Studies demonstrated that VEGF directly stimulates migration and differentiation of primary human osteoblasts.Furthermore, It mediates various osteoinductive factors such as IGF,TGF and FGF-2 for bone formation

HA & POLYMERS

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HYDROXY APATITE

Hydroxyl apatite is a mineral found in teeth and bones within the body. It is naturally occurring calcium phosphate mineral. It has good biocompatibility and excellent bone bonding ability due to its similarity to the mineral constituents of human bone and teeth. It occurs mainly in crystalline forms but in some cases it exists in amorphous forms also. The hydroxyl ion of hydroxyl apatite can be replaced by halides like chlorides and fluorides. A hydroxyl apatite crystal occurs in different colours like green, brown and yellow.

The hydroxyl apatite has good porosity. So, it helps rapid growth of bone cells through the pores. Owing to its high bio activity and bio compatibility hydroxyl apatite is commonly used as filler in polymer based bone substitute. The main aim of hydroxyl apatite with the polymers is to replace extra cellular matrices. The hydroxyl apatite should not have good mechanical property. So, it cannot be used alone as a transplants for bones. This problem can be solving by mixing hydroxyl apatite with high molecular weight polymers.

POLYMERS

Polymers are chemical substances which are having high molecular weight. They are long chain compound which consist of monomers combined with chemical bonds. They are highly elastic and low in stiffness. By combining polymers and ceramics into composites, the mechanical properties will be greatly enhanced, as the problem of brittleness and the difficulty of shaping hard ceramics can be overcome. There are two type of polymers can be used in this occasion, PBMA (Polybutyl methacrylate) and PEVA (Poly ethylene co vinyl acetate) Polymers can be used as scaffolds to promote cell adhesion, maintenance of differentiated, cell function and direct the growth of cells and help in the function of extracellular matrix.

How Hydroxyl Apatite Scaffold helpful in Tissue Engineering?

2011-11-30T05:13:00.000-08:00

HYDROXYL APATITE SCAFFOLD IN TISSUE ENGINEERING

Tissue engineering is one of the most promising method to replace, repair and maintenance of the whole tissues or organs in the human body. Tissue engineering applications has limited due to the deficiency of organs for transplantation. Scaffolds are the artificial substitutes for extracellular matrix which provides an environment in tissue engineering to assist the body to repair itself by delivering the necessary cells to repair damaged tissues. Scaffold matrix slowly degrades in the body after the complete growth of tissue or organs.

Bones are rigid tissues that form part of the endoskeleton of vertibrates.They have different functions in the body like move,support,protect various organs and produce red and white blood cells. So each bone defects may lead to serious illness. Bone substitutes are used in the skeletal deficiencies from the middle of nineteenth century. The two methods commonly used for bone deficiencies are auto grafting and allografting. In allografting the bone used for transplantation is taken from different individual. But in autographing the bone is taken from same individual. Although biological graft such as autograft, allograft or xenografts have some advantages in biological bone regeneration, their wider application is limited because of its histocompatibility, restricted supply and secondary surgery.

Bio ceramics/polymer composites have been applied widely to matrices for bone tissue engineering. The interaction of the cells with these matrices are main advantage for the selecting these composites for bone regeneration.Bioresorbable scaffolds seeded with the appropriate type of cells, should provide a template for tissue regeneration. While it slowly resorbs and degrades, to finally leave no foreign substances in the body, thus reducing the risk of inflammation.

Certain attempts were made to prepare the bone substitutes with good mechanical properties which are similar to the natural bone.These techniques are beneficial to an extend but lack some properties. If the interaction between both the phases is week it will create problem during the transfer of stresses. So the polymer used for the scaffold preparation must have good interaction with the ceramic. This criteria leads to the preparation of blends with polymers having good interaction with the ceramics like hydroxyl apatite.

Continue on next blog............

METHODS FOR THE PREPARATION OF HYDROXY APATITE /POLYMER BLENDS

2011-11-29T02:28:00.000-08:00

METHODS FOR THE PREPARATION OF HYDROXY APATITE /POLYMER BLENDS

There are different types of methods are available for the preparation of hydroxyl apatite /polymer blends. They are classified as conventional and rapid prototyping methods.

CONVENTIONAL METHODS

Solvent casting

Particulate leaching

Cold isostatic pressing

Solution mixing

Gas foaming

RAPID PROTOTYPING

Selective laser sintering

Low temperature deposition manufacturing

Electro spinning

Robocast

Bio plotter

CONVENTIONAL METHODS

SOLVENT CASTING

In this method polymers are dissolved in the appropriate solvent with the help of mixers. The polymers which are soluble in the solvents are used for this process. The next step in this process is casting with the help of an air stream. Then it dries. The uniformity in the thickness is the main advantage of this technique.

PARTCULATE LEACHING

In this technique the polymers are dissolved in the organic solvent (eg.chloroform) at 50°C.After that the hydroxyl apatite is mixed with polymer solution under 300 rpm.The solutions is then mixed in a sonicator for the uniform distribution of the particles. The main aim of this technique to produce the bigger pore size. The scaffold which are used for the bone replacement must have higher pore size .It provides a high void volume for vascularisation and nutrient diffusion.

COLD ISOSTATIC PRESSING

This is the very popular method for the preparation of hydroxyl apatite /polymer scaffolds. The hydroxyl apatite is mixed with polymer and the sodium chloride. This powder mixture is placed in a mould and then the pressure is applied in all directions. The main advantage of this method is the high porous surface which gives good interaction while transplantation.

SOLUTION MIXING

Solution mixing is widely used for the preparation of hydroxyl apatite /polymer scaffolds. The hydroxyl apatite is first surface grafted. Surface grafting of hydroxyl apatite is done by drying the hydroxyl apatite at 120°C followed by mixing it with xylene solution. This solution again mixed with lactide solution.Stirr the solution at 120°C up to 18 hrs.Then wash it with chloroform for five times and dried at 60°Cfor one day. Then it mixed with polymers solution. The precipitation is done by using ethanol and dried for 24 hrs at a temperature of 50°C

GAS FOAMING

In this method gas is used to prepare scaffolds. The ceramics are dried at a temperature of 105°C for one day to prevent degradation. The supercritical carbon dioxide is commonly used for this process. Ceramic materials are then mixed with the polymers by melt extruding techniques. Melt extrusion is carried out at high temperature above 200°C under the flow of nitrogen. This is followed by the foaming process which is carried out in the foaming chamber. The pressure inside the chamber is increased till it reaches the saturation pressure. During this time the polymer is completely saturated by gas. By the releasing the gas quickly from the chamber the foaming is achieved. This leads to the formation of small porous structure. The good porous structure of the blend may be due to the polymeric carbonyl group interaction with the carbon dioxide.

RAPID PROTOTYPING METHODS

SELECTIVE LASER SINTERING

This is a technique which uses carbon dioxide laser beam to sinter the polymeric materials to make the blends of 3D structure. The laser beam is used to scan the powder surface. The temperature of the powder increases above the glass transition temperature, when the laser beam interacts with the powder. The elevated temperature is less than the melting point of the particles. The deformation of the powder particle will occur. It adhere together to form layer. By depositing various layers on the top of the previous layers we can prepare the scaffolds.

LOW TEMPERATURE DEPOSITION MANUFACTURING

This is a new method developed for the preparation of scaffolds. This method can be used only for the preparation of scaffolds using calcium phosphate. Polymer is mixed with the dioxane solvent used for this process. Then hydroxyl apatite is added into it and makes it in the form of slurry. After the preparation of slurry it is passed through LDM system through a pipe which has a small opening. The temperature is controlled at 0°C.The slurry is deposited on the platform in the bottom. New layers are deposited above the first layer. The prepared scaffolds are then freeze dried for solvent removal.

ELECTROSPINNING

Electrospinning is the common method used for the preparation of the scaffolds after the invention of the nanoparticle.Hydroxy apatite is prepared by mixing phosphoric acid and calcium hydroxide at room temperature. The pH should maintain at a basic range. It is then stirred and centrifuged and washed with water. Collagen is the natural protein obtained from animal source mixed with hexafluoropropanol.Then hydroxyl apatite is added into it by constant stirring. This solution is sprayed using a syringe to an aluminium foil. An electrostatic field is generated in the surrounding. It is then electro spun for 5 hours and linked to polymers to obtain the nano hydroxyl apatite /polymer scaffolds.

ROBOCAST

This is the type of fabricating technique developed by Sandia national laboratory. The robocast assembly consist of an elevator, platform and the nozzles. The paste form of ceramic used for this technique. The extrusion head is filled with this ceramic paste. The paste is ejected from the extrusion head in the form of filaments. After the complete removal of the water will provide a rigid structure of the scaffolds. It is then fired to remove the organic binders.

BIOPLOTTER

This technique almost similar to the robocast fabrication method. The material is filled in the extraction head which is then ejected through the nozzle. It is then solidified by the change in temperature. The scaffolds with required strength are obtained.Hyaluronic acid and alginate are used to amend the exterior of the scaffolds. The cell culture studies prove that efficiency in seeding is about 30%.

Fourier Transform Infrared Spectroscopy (FTIR)

2011-11-28T04:19:00.000-08:00

Fourier Transform Infrared Spectroscopy (FTIR)

FTIR provides specific information about chemical bonding and molecular structure of the materials. It works based on the principle of absorption. The chemical bond in the sample vibrates at characteristic frequencies when it exposed to infrared radiation. Measuring the radiation of absorption as a function of frequency produces a spectrum that can be used for the detect functional group and compounds. The spectrometer consists of sample, source and detector. It works on the basis of Michelson`s interferometer.

The sample is grinded to make fine powder and dispersed in the Nujol oil. Then it loaded in the instrument for scanning. The main advantage of this technique is the accuracy in the spectral frequency. Moreover it is capable of identifying organic functional groups and often specific organic compound. The ambient condition (not vaccum, good for volatile compound) and typically non-destructive features are unavoidable features of FTIR.

Differential Scanning Calorimetry (DSC)

2011-11-27T04:51:00.000-08:00

Differential Scanning Calorimetry (DSC)

DSC is an analytical technique which is used to measure the heat required to raise the temperature of the sample and reference as a function of temperature. The technique provides information regarding to the physical and chemical changes that involve endothermic and exothermic process using a little amount of sample. There are two types of DSC instruments: heat flux and power compensation instruments. In power compensation DSC, sample and reference materials are placed in different furnaces and the power input to the furnaces is measured at constant temperature.

The DSC cell is placed in cylindrical structure. The sample and reference sample are placed on the platform. The heat is passed through a Constantine wire. The chromel disc and alumel wires are connected to the platform through the bottom. The temperature of the sample and reference can be measured independently by the formation of the chromel-alumel junction.

DSC has many advantages including its fast analysis time, easy sample preparation, applicability to both solids and liquids, a wide range of temperature applicability and quantitative capability. Moreover it allows accurate determination of temperature associated with thermal events.DSC can be used to measure

Glass transition temperature

Melting and boiling point

Crystallization time and temperature

Percent crystallinity

Oxidative stability

Thermal stability and percent purity.

Scanning Electron Microscopy (SEM)

2011-11-26T04:36:00.000-08:00

Scanning Electron Microscopy (SEM)

SEM is one of the most widely used analytical techniques in industry due to the extremely detailed images it can provide. It is a microscope that uses high energy beam of electrons instead of light to form an image. The SEM consists of an electron gun, anode, magnetic lens, scanning coil and detectors. The electron beams comes from electron gun fitted with a tungsten filament cathode. The anode produces powerful attractive forces for electrons which cause electrons to accelerate toward the anode. The electrons pass through electromagnetic fields and lenses which focus the beam down toward the sample. The electrons and X-rays are ejected from the sample when the beam hits the sample.

Detectors collect all electrons and X-rays and convert them into signal that is sent screen. These signals that contain information about sample surface, composition and electrical conductivity. These produce the image of the sample.

Sample preparation is very important task in scanning electron microscopy. All moisture content on the surface of the sample must be removing by drying. All non metals need to be made conductive by covering the sample with a thin layer of conductive material. This is done by using a device called a sputter coater. The sputter coater uses an electric field and argon gas. The electron field and argon gas help to remove electron from argon and became a positive charged atom. The argon ions become attracted to a negatively charged gold foil. These gold atoms cover the surface of the sample and produce a thin gold coating.SEM has many advantages over traditional microscope’s large depth of field, which allows a large amount of the sample to be in focus at one time. The SEM also produces images of high resolution, which means that closely spaced features can be examined at a high resolution.

Schedule Y in clinical trial

2011-11-24T07:11:00.000-08:00

SCHEDULE Y

Requirements and guidelines for permission to import and/or manufacture of new drugs for sale or to undertake clinical trials.

Studies in special populations

Geriatrics
Paediatrics
Pregnant or Nursing women

Geriatrics

Usually conduct Phase III trials.

Phase II can do only certain situation-

        a)The disease of aging.
        b)Availability of large geriatric population.
        c)Conditions common in the elderly people.
      d)Drug is likely to alter the geriatric response(safety & efficacy) compared     with that of the non-geriatric patient.

Paediatrics

Clinical development begins with older children.

Initial safety & tolerability data should collect from adult.

Paediatric population should be included in the clinical trials early in case of serious & life-threatening diseases

The paediatric studies should include-
a)Clinical trials
b)Relative bioequivalence comparison with adult formulation.
c)Pharmacokinetic studies for dose selection.

Informed consent obtained from the parents or legal guardian.

Participants can withdraw from study at any time, however, parents and investigator opinion essential.

Ethics committee should include members who are knowledgeable about pediatric,ethical,clinical and psychosocial issues.

Pregnant and Nursing women

Drug should be intended to use only for the pregnant/nursing women.

Excretion of the drug or its metabolites into human milk should be examined.

The infant should be monitored for predicted pharmacological effects of the drug.

The power of communication

2011-11-22T10:01:00.000-08:00

Communication is inevitable in today's world.In every stages of life,communication must have its own important.Communication is essential to succeed in life despite the sophisticated technology on other side.Communication is a process by which people exchange their own ideas and feels with each other.

The power of communication mainly deals with the effect of one's command on other people.In the middle of cut throat competition and rat race,the effective communication will reserve a place for good future.Sometimes,the aggressive voice makes feel fear on others.Is it really due to the power of communication?Absolutely no.It brings more annoyance rather than makes them merry.Is the commanding voice is part of the powerful communication?Definitely no.It irritates others to doing works. Ultimately,what is the power of communication?It is the friendly conversation or sharing of ideas and thoughts between two or more people.In depth knowledge about the subject is essential for good communication.

People at the college or workplace communicate with each other to ensure that everything is done according to the protocol or not.Lack of communication can spoil the growth of any organization by procrastination and misunderstanding.So,it is vital to communicate effectively each other.

There are lots of medium available for the powerful communication.Electronic medium like telephone,fax,pager are pushed back by e-mail.People consider e-mail is the quicker,safer and cheaper than other medium.Moreover,the art of words in the e-mail bring more pleasure to the reader than other disgusting medium.The sender always make sure the array of the words are correct and it brings attractiveness to others in a powerful manner.This blog describes,how to do powerful communication without any fault?This is really helpful for those who want to prepare for the English language exams and interviews.