By Sarfaraz K. Niazi
As the usual pharmaceutical keeps to develop and thrive, so does the necessity to behavior effective and winning bioequivalence stories. lately, there were major adjustments to the statistical types for comparing bioequivalence, and advances within the analytical know-how used to become aware of drug and metabolite degrees have made bioequivalence trying out more challenging to behavior and summarize. The instruction manual of Bioequivalence Testing deals a whole description of each point of bioequivalence testing.
- Describes the present analytical equipment utilized in bioequivalence trying out, in addition to their respective strengths and limitations
- Discusses around the globe regulatory standards for submitting for approval of typical drugs
- Covers GLP, GCP, and 21 CFR compliance specifications for qualifying stories for regulatory submission and facility certification
- Includes real examples of news authorized through regulatory gurus to demonstrate a number of medical, regulatory, and formatting aspects
- Provides an inventory of proprietors for the software program used to investigate bioequivalence experiences and suggestions
- Explains the best way to observe for a waiver, how you can safe regulatory approval of stories, and the way to acquire regulatory certification of amenities accomplishing bioequivalence studies
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Additional info for Handbook of Bioequivalence Testing: 002 (Drugs and the Pharmaceutical Sciences)
Handbook of Bioequivalence Testing: 002 (Drugs and the Pharmaceutical Sciences) by Sarfaraz K. Niazi