Best Practices for Drug Substance Stress and Stability Studies During Early Stage Development. Part III—How to Make Science- and Risk-based Stability Testing Decisions for Drug Substance Batches Produced after Manufacturing Process Changes

Journal of Pharmaceutical Innovation - Tập 8 Số 4 - Trang 229-239 - 2013
Q. Chan Li1, Fenghe Qiu1, W.H. McWilliams1, Cheryl Pape2, Jinhua J. Song1, F. Swanek1, Xiaojun Wang1, Kenneth A. Cohen1, Dennis O’Connor1
1Development US, Boehringer Ingelheim Pharmaceuticals, Incorporated, Ridgefield, CT, 06877, USA
2Now Regulatory Affairs, CMC, AbbVie Pharmaceuticals (formerly Abbott), Abbottt Park, IL, 60064, USA

Tóm tắt

Từ khóa


Tài liệu tham khảo

Chan Li Q, Qiu F, Cohen K, Tougas T, Li J, McCaffrey J, et al. Best practices for drug substance stress and stability studies during early-stage development, Part I—conducting drug substance solid stress to support phase Ia clinical Trials. J Pharm Innov (JPI). 2012;7(3):214–24.

Chan Li Q, Qiu F, Cohen K, Tougas T, Li J, McCaffrey J, et al. Best practices for drug substance stress and stability studies during early-stage development Part II—conducting abbreviated long term and accelerated stability testing on the first clinical drug substance batch to confirm and adjust the drug substance retest period/powder for oral solution shelf life. J Pharm Innov (JPI). 2013;8(1):56–65.

International Conference on Harmonisation Guidance (ICH) Q1B: Stability testing: photostability testing of new drug substances and products, November 1996

Colgan ST, Whipple RD, Watson TJ, Nosal R, Beaman JV, DeAntonis DM. The application of quality by design's science and risk based concepts to API stability strategies. September: AAPS Stability Workshop; 2009.

Colgan ST, Watson TJ, Whipple RD, Nosal R, Beaman JV, De Antonis DM. The application of science and risk based concepts to drug substance stability strategies. J Pharm Innov (JPI). 2012;7(3–4):205–13. doi: 10.1007/s12247-012-9135-9 .

Acken B, Alasandro M, Colgan S. Paul Curry, Frank Diana, Q. Chan Li, Z. Jane Li, Tony Mazzeo, Andy Rignall, Z. Jessica Tan, Robert Timpano. Early development GMPs for stability—an industry perspective (Part IV). Pharmaceutical Technology. 2012;29(9):64–70.

J.V. Beaman. Stability testing—doing everything or doing the right thing? Pharm. Rev. Apr July/August 2010; 73–76

International Conference on Harmonisation Guidance (ICH) Q9: Quality risk management, dated 9 November 2005

International Conference on Harmonisation Guidance (ICH) Q10: Pharmaceutical quality system, dated 4 June 2008

International Conference on Harmonisation Guidance (ICH) Q11: Development and manufacture of drug substances (Chemical entities and biotechnological/biological entities), dated 1 May 2012

International Conference on Harmonisation Guidance (ICH) Q3A(R2): Impurities in New Drug Substances, dated October 2006

US FDA. Guidance for industry: INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information, May 2003. http://www.fda.gov/cder/guidance./index.htm

Canada GUIDANCE DOCUMENT Quality (Chemistry and Manufacturing) Guidance: clinical trial applications (CTAs) for pharmaceuticals, Effective Date 2009/06/01. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/qual_cta_dec-eng.pdf

European Medicines Agency (EMA): Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials—CHMP/QWP/185401/2004 Final, 31 March 2006. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003484.pdf