Thursday, December 30, 2010

Pharmaceutical Inspiration and The Post Populi 2010

Pharmaceutical Inspiration and The Post Populi  2010 , Most Popular Articles in 2010.
We wish you a very prosperous and happy new year 2011.

In today's post we are providing you the most popular articles of 2010.As well as an article  which you must read. It is really inspiring. We like to share it with every one associated with pharmaceutical industry it is very inspiring  hence one should read that article completely we have provided it below the most popular articles.
Such are few things that is why we call our company Pharmaceutical Inspiration.    

Here are the links to Popular Articles

Validation in Pharma Industry

Clean Room Classification

Media Fill Run in sterile dosage form manufacturing

What is ( HEPA )High Efficiency Particulate Air filter

How to investigate out of specification resuts.

CFR 21 PART 11 compliance current status and its implementation.

Quality Assurance in Pharma Industry

Annual Product Qualit Review guidelines for your pharma companies

Laminar Air Flow Cabinets and Bio Safety Cabinets

Pharma Companies , Pharmaceutical companies from all around the world

Here is the most Inspiring article.

US FDA honors woman who rejected thalidomide and saved millions of American children's from thalidomide.

Dr Frances Oldham Kelsey a former US FDA employee a medical officer and doctorate in pharmacology from University of Chicago and was honored by FDA on 13 sep 2010.

As in 1960s as she played a vital role in ensuring that the tragedy drug thalidomide do not get marketing approval in United States of America.

Dr Frances Oldham Kelsey, Now 96 year old lady and a retired US FDA employee refused to approve Kevadon a brand that contained thalidomide  manufactured by pharmaceutical company William S Merrell was restricted to distribute thalidomide in the US after she learnt that the drug is linked with birth defects in Europe.

At that time thalidomide was prescribed to pregnant women for to treat morning sickness and to get good sleep. and, it was not known that thalidomide taken by a mother could affect the foetus.

In the late 1950s and early 60s in Europe thousands of babies were born without limbs, and it was reported later that the birth defects in children’s were developed where ever the mothers of these children’s were prescribed drug thalidomide in pregnancy.

But in US at that time about 40 children’s were born with birth defect as the drug was already distributed through physicians to about 20,000 patients as a part of trial without need for an approval (it was allowed at that time) most of the women took the drug and were not informed about the trial.

Dr Frances Oldham Kelsey was under tremendous pressure from pharma industry for approving the drug , as the drug was already approved in other 20 countries in Europe.

Her decision at that time saved millions of American children’s from the drug thalidomide and the story led the US Congress to set rigid rules for testing and marketing any new drugs in United States of America, which also included a requirement from pharmaceutical companies conduct trials where the patients participating in clinical trial are well informed and a well informed consent is required by patients participating in clinical trial.

Dr Frances Oldham Kelsey was awarded highest civilian award by then President John F. Kennedy and became the second woman to receive it.

Do you know now this website has become a most popular and most referred website in pharmaceutical industry and in pharmaceutical companies by pharmaceutical manufacturers from all over the world for almost all topics related to FDA guildelines, GMP guidelines for Pharmaceutical Manufacturing (Current Good Manufacturing Practice for Pharmaceutical Manufacturing , c GMP guidelines ),and technical aspects of pharma manufacturing research and development , Pharma Regulatory Affairs  and latest news and new drugs developments.
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What is Therapeutic Index ?

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What is an Isolator in pharmaceutical manufacturing.?

What is 21 CFR Part 11, US FDA compliance and CFR 21 Part 11?

CFR 21 part 11 and its application on computarised systems used in clinical trials US FDA guidelines

What is High-Efficiency Particulate Air  HEPA Filter

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 )

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Mechanism of drug resistance

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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

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Antibiotic Definition and classification

Antibiotic Resistance and Antibiotic resistance mechanism

Antioxidants food supplements

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Terminologies In vaccine Production

Multi stage testing of Virus vaccine production

Testing of vaccines at different stages of production


Enzyme linked immunosorbent assay ELISA

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Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definitions.

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




Controlling Pyrogens in injectable dosage forms

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

Injectable Dosage Form Asepict Techniques  Sterile dosage form manufacturing imprtant aseptic techniques

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


Electronic record in pharmaceutical manufacturing industry

Good manufacturing practice in pharmaceutical industry

Pharmaceutical industry pharmaceutical companies and FDA latest updates

Here is an interesting article on world wide pharmaceutical industry and making a carrier in one of pharmaceutical companies article on Pharmaceutical Industry pharmaceutical industry

Find a Job in Pharmaceutical Company -->JOBS IN PHARMA INDUSTRY<---
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Useful Books For Pharmaceutical Manufacturers and Pharmaceutical Professionals
What is Therapeutic Index ?

What is Narrow Therapeutic Range Drug?

What is What is a High-Efficiency Particulate Air (HEPA) filter ?

What is 21 CFR Part 11, US FDA compliance and CFR 21 Part 11.

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