Pharmacy

Handbook of Bioequivalence Testing, Second Edition by Sarfaraz K. Niazi

By Sarfaraz K. Niazi

Because the usual pharmaceutical keeps to develop and thrive, so does the necessity to behavior enough, effective bioequivalence reports. in recent times, there were major alterations to the statistical types for comparing bioequivalence. furthermore, advances within the analytical know-how used to realize drug and metabolite degrees have made bioequivalence trying out extra complicated. the second one variation of Read more...

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Additional info for Handbook of Bioequivalence Testing, Second Edition

Example text

FDA............................ 3 Factors Determining the Establishment of BE Requirement by the FDA............ 4 Drugs with Potential BE Problems....................................................................... 5 Classification of Active Ingredients According to Their Health Risk.................. 1 Various Parameters Used in IVIVC Level Assignments...................................... 2 Biopharmaceutical Drug Classification and Associated Likelihood of IVIVC for Immediate-Release Drug Products..................................................................

Chapter 18: Bioequivalence Documentation. Bioequivalence Reports provides a practical guide to writing reports for regulatory submissions along with several examples of reports submitted to regulatory authorities. Also included is a list of standard SOPs that sponsors may want to consider adopting.

661 Objective of an Analytical Method...................................................................... 663 Objective of the Pre-Study Validation Phase....................................................... 663 Classical Design in Pre-Study Validation............................................................ 664 Pre-Validation....................................................................................................... 666 Reference Standard...............................................................................................

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