MHRA Guide for GLP regulations
MHRA Guide for GLP Regulations
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Root Cause Analysis (RCA)
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Identifying the root cause for market complaints, out of specifications (OOS), deviations can be challenging, but a number of...
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MHRA Guide for Labeling and Packaging
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MHRA guide for labeling and packaging
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US FDA issues draft norms on waiver of in-vivo BA & BE studies for subsequent analysis; pharma cos to save time, cost – Courtesy(Pharmabiz.com)
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The US FDA has issued draft guidelines on waiver of in-vivo bioavailability (BA) and bioequivalence(BE) studies for immediate release...
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Lipid excipients and delivery systems for pharmaceutical development: A regulatory perspective☆
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1-s2-0-s0169409x07003195-main-1Download
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A REVIEW ON GOOD MANUFACTURING PRACTICE (GMP) FOR MEDICINAL PRODUCTS
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ABOUT AUTHORS:Vikash Kumar Chaudhari1*, Vijay Yadav2, Praveen Kumar Verma1, Amit Kumar Singh21Department of Pharmaceutical Chemistry,2Department of Pharmacognosy,Kunwar Haribansh Singh...
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A REVIEW ON STABILITY GUIDELINES BY ICH AND USFDA GUIDELINES FOR NEW FORMULATION AND DOSAGE FORM
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ABSTRACTStability guidelines for new drug substance and new pharmaceutical formulations as per ICH and USP for the evaluation and...
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Federal Circuit Says Regulatory Patent Term Extension Prolongs Life of Entire Patent – Courtesy(Pharma Patents)
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POSTED BY COURTENAY C. BRINCKERHOFF ON 3 NOVEMBER 2011POSTED IN FEDERAL CIRCUIT DECISIONS;PATENT TERM EXTENSIONI wrote previously about the patentability issues raised in Genetics Institute,...
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What Is an Abbreviated New Drug Application, And What Does It Mean to Investors?
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Over the past year, a lot of investor attention has been focused on drugmakers as the industry increases its...
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