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Friday, July 16, 2010

Post market studies of a drug

What are post market studies of a drug.
After any of new drug or medical device is approved by US FDA , it is required that the drug and the medical device to be reviewed for its safety and efficacy even after it is released or approved by FDA , hence  new drug or medical devices are monitored for any of the adverse effects which may not be reflected in the actual clinical trials up to last stage , due to any reason.

US FDA approves a drug after through review of the filed technical documents, after the outcomes are found satisfactory , and grants approval with the condition of post market surveillance to ascertain that the new drug or the medical device approved is really as safe and effective as it was found in the clinical trials.

Following are the CFR'S pertaining to post market surveillance

21CFR310.305  Records and reports concerning adverse drug experiences of marketed prescription drugs for human use without approved new drug applications

21CFR312.32  Investigational New Drug Safety Reports

21CFR314.80 Post marketing reporting of adverse drug experiences

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What is What is 510(k) Clearances ?
What is 510(k) Clearances, Premarket Notification for medical devices - PMN or 510(k)


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http://whoguideline.blogspot.com/2010/04/terminalogy-and-their-explanations.html

Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definations.

http://whoguideline.blogspot.com/2010/02/pharmaceutical-aseptic-manufacturing.html

Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in pharmaceutical industry

Pharmaceutical Validation

Types of validations in pharmaceutical manufacturing


Requirements of documents for validation of sterilisation process

How to investigate OOS out of specification results

Determination of Phenol coeeficient of a disinfectant

Sterility testing

Cleen Room Classification

Time limitations in sterile pharmaceuticals processing

Aspects of validation of manufacturing process in sterile pharmaceuticals

Clinical Trials

Controling Pyrogens in injectable dosage forms

Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation

New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA

Abbreviated New Drug Application (ANDA) What is ANDA , detaied information about ANDA preparation and submission to US FDA

How to make Investigational New Drug (IND) Application to US FDA

Drug applications submission to us fda Over the counter Drugs OTC drugs

BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

Eletronic record in pharmaceutical manufacturing industry

Good manufacturing practice in pharmaceutical industry

Pharmaceutical industry pharmaceutical companies and FDA latest updates

Here is an intresting article on world wide pharmaceutical industry
Article on Pharmaceutical Industry pharmaceutical industry

Here are some interesting articles on Quality assurance systems for pharmaceutical company
1.Quality assurance in pharma industry

2.Quality by designe concept for pharmaceutical industry

3.Quality by designe concept in pharmaceutical industry an  explanation

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