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
http://whoguideline.blogspot.com/2010/03/validation-in-pharmaceutical.html
Clean Room Classification
http://whoguideline.blogspot.com/2010/02/clean-room-classification-aspects-of.html
Media Fill Run in sterile dosage form manufacturing
http://whoguideline.blogspot.com/2010/03/media-fill-run-to-ensure-sterility.html
What is ( HEPA )High Efficiency Particulate Air filter
http://whoguideline.blogspot.com/2010/12/what-is-high-efficiency-particulate-air.html
How to investigate out of specification resuts.
http://whoguideline.blogspot.com/2009/09/how-to-investigate-out-of-specification.html
CFR 21 PART 11 compliance current status and its implementation.
http://whoguideline.blogspot.com/2010/12/21-cfr-part-11-us-fda-compliance-and.html
Quality Assurance in Pharma Industry
http://whoguideline.blogspot.com/2009/08/quality-assurance-systems-in.html
Annual Product Qualit Review guidelines for your pharma companies
http://whoguideline.blogspot.com/2009/07/annual-product-quality-review-of.html
Laminar Air Flow Cabinets and Bio Safety Cabinets
http://whoguideline.blogspot.com/2010/12/what-is-laminar-air-flow-cabinet.html
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.
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