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Knowledge Bank

27

Mar'15

List of Code of Federal Regulations (CFR) related to BA/BE studies [With links]

About Code of Federal Regulations (CFR):   CFR is the codification of the general and permanent rules and regulations published in …

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08

Feb'15

USFDA New Guidances Publishing in 2015

Center for Drug Evaluation and Research(CDER) -FDA  is planning to publish, new and revised guidances in calendar year 2015   …

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06

Feb'15

FDA warning letters-2015 on Data Integrity Issues

FDA issued two warning letters in January 2015 relating to Data Integrity Data integrity is essential requirement in a pharmaceutical …

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20

Jan'15

Tablet Coating Problems in Pharma Manufacturing : How to Solve

Coating problems occurs during manufacturing of tablets in Pharma industries In this article, we will discuss various coating problems occurs …

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24

Dec'14

Rapivab (Peramivir) got US FDA Approval

On December 19, the U.S. Food and Drug Administration approved Rapivab (Peramivir) to treat influenza infection in adults. Influenza, commonly …

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24

Dec'14

An Over view of Stability Testing of Pharmaceutical Products

Over view of Stability Testing of Pharmaceutical Products What is Stability? Stability of a pharmaceutical product may be defined as …

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