Contract research organization commentary on the importance of harmonization and the impact of ICH M10-Reference-Cited by-同舟云学术

Contract research organization commentary on the importance of harmonization and the impact of ICH M10

Published:2019-09 Issue:18 Volume:11 Page:1727-1729
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Briscoe Chad¹,Nehls Corey²,Buonarati Mike³,Cape Stephanie⁴,Islam Rafiqul⁵,Satterwhite Christina⁶,Hayes Roger⁷

Affiliation:

1. PRA Heath Sciences, Lenexa, KS 66219, USA

2. PPD, Wilmington, NC 28401, USA

3. Intertek Pharmaceutical Services, LCMS, San Diego, CA 92121, USA

4. Covance Laboratories Inc., Bioanalytical Chemistry, Madison, WI 53704, USA

5. Celerion Inc., 621 Rose Street, Lincoln, NE 68502, USA

6. Charles River Laboratories, Wilmington, MA 01887, USA

7. ICON plc, Whitesboro, NY 13492, USA

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Link

https://www.future-science.com/doi/pdf/10.4155/bio-2019-0231

Reference28 articles.

1. Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies

2. US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research, Center for Veterinary Medicine. Guidance for industry, bioanalytical method validation (2001). www.fda.gov/downloads/Drugs/Guidance/ucm070107.pdf

3. EMA. Committee for medicinal products for human use (CHMP). Guideline on bioanalytical method validation (2011). www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf

4. US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research, Center for Veterinary Medicine. Guidance for industry, bioanalytical method validation (2018). www.fda.gov/regulatory-information/search-fda-guidance-documents/bioanalytical-method-validation-guidance-industry

5. ANVISA. Resolution RDC 27 minimum requirements for bioanalytical method validation used in studies with the purpose of registration and post-registration of medicines. Agencia National de Vigilancia Sanitaria, Brazil (2012). http://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?jo rnal=1&pagina=93&data=22/05/2012