Author:
Smolec JoMarie,DeSilva Binodh,Smith Wendell,Weiner Russell,Kelly Marian,Lee Ben,Khan Masood,Tacey Richard,Hill Howard,Celniker Abbie,Shah Vinod,Bowsher Ronald,Mire-Sluis Anthony,Findlay John W. A.,Saltarelli Mary,Quarmby Valerie,Lansky David,Dillard Robert,Ullmann Martin,Keller Stephen,Karnes H. Thomas
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Organic Chemistry,Pharmaceutical Science,Pharmacology,Molecular Medicine,Biotechnology
Reference5 articles.
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2. International Conference on Harmonization. ICH Q2A. Text on Validation of Analytical Procedures. Federal Register. 1995;60 FR 11260. http://www.fda.gov/cder/guidance/ichq2a.pdf..
3. International Conference on Harmonization. ICH Q2B. Validation of Analytical Procedures Methodology. Federal Register. 1997;62 FR 27463. http://www.fda.gov/cder/guidance/1320fnl.pdf..
4. US Department of Health and Human Services. Draft Guidance for Industry: Analytical Procedures and Methods Validation, Chemistry, Manufacturing and Controls Documentation. Rockville, MD:US Dept of Health and Human Services, Food and Drug Administration. Aug 2000. http://www.fda.gov/cder/guidance/2396dft.pdf..
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