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What is 21 CFR Part 11, US FDA guidelines requirements of FDA compliance and CFR 21 Part 11.
What is a Site Master file of a pharmaceutical company
What is Generic Drug
What is Reference Listed Drug ? ( RLD )
What is Pharmaceutical Equivalents
What is Pharmaceutical Alternatives
What is Therapeutic Equivalents
What are Post Market studies
Why a drug is bound to protein, What is protein binding? What is drug absorption , distribution ?
Do Physical properties contribute to drug activity.
What is drug receptor , How a drug resistance occurs
Mechanism of drug resistance
What is drug interaction
Drug interaction, and its examples
What is first pass metabolism of a drug
What is What is 510(k) Clearances ?
What is 510(k) Clearances,
Premarket Notification for medical devices - PMN or 510(k)
What is a drug interaction
Examples of drug interactions
Antibiotic Definition and classification
Antibiotic Resistance and Antibiotic resistance mechanism
Antioxidants food supplements
Vitamin D Details on FDA cautions on accurate dosage of Vitamin D
What is an antibody? what is monoclonal and polyclonal antibodies?
Terminologies In vaccine Production
Multi stage testing of Virus vaccine production
Testing of vaccines at different stages of production
TESTING FOR ADVENTITIOUS AGENTS CELL PROPERTIES IN VIRAL VACCINE PRODUCTION
Enzyme linked immunosorbent assay ELISA
Raido Immuno assay
http://whoguideline.blogspot.com/2010/04/terminalogy-and-their-explanations.html
Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definitions.
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 coefficient of a disinfectant
Sterility testing
Clean Room Classification
Time limitations in sterile pharmaceuticals processing
Aspects of validation of manufacturing process in sterile pharmaceuticals
Clinical Trials
Requirements of US FDA Inspections of Clinical Investigators of Clinical Trials
PROCEDURE OF AN INSPECTIONS OF CLINICAL TRIAL INVESTIGATOR BY US FDA HOW ARE CLINICAL INVESTIGATOR INSPECTIONS CONDUCTED?
US FDA INSPECTION OF CLINICAL INVESTIGATORS OUT OF UNITED STATES OF AMERICA
REPORTS AFTER AN INSPECTION OF A INVESTIGAOTR OF CLINICAL TRIALS
Controlling 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 , detailed 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
Electronic record in pharmaceutical manufacturing industry
Good manufacturing practice in pharmaceutical industry
Pharmaceutical industry pharmaceutical companies and FDA latest updates
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