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THE PHARMA REVIEW (NOVEMBER DECEMBER 2012)

Application of Contemporary Concept of Qbd, DoE and Fbd for Drug Development

Roop K. Khar & Vandana Chaudhary

Introduction:
 
Quality regulation of medicinal drug product started in early 19thcentury. Initially the scientific streams related to basic sciences like chemistry, physiology and pharmacology provided a strong foundation of quality attributes in modern drug research and development. Even though various undesirable events like thalidomide and others occurred due to improper quality controls mechanism of drug products at various stages but they provided a strong impetus for the development of medicinal regulation namely federal food drug and cosmetic act with the pre-market notification requirement for new drug in 1938.

 

 

 

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