Historical perspective on the development and evolution of bioanalytical guidance and technology
Author:
Affiliation:
1. Pharmaceutical Consultant, North Potomac, MD 20878, USA.
2. Hoffmann-La Roche Inc., Nutley, NJ 07110, USA
Abstract
Publisher
Future Science Ltd
Subject
Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry
Link
http://www.future-science.com/doi/pdf/10.4155/bio.11.45
Reference12 articles.
1. Regulatory observations in bioanalytical determinations
2. US 21 Code of Federal Regulations, Food and Drugs. 320.29 Analytical methods for anin vivobioavailability study. 42 FR 1648, 7 January 1977, as amended at 67 FR 77674, 19 December 2002.
3. US FDA. Draft Guidance for industry: bioanalytical method validation. (1999).
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