On the shelf life of pharmaceutical products

AAPS PharmSciTech

Volumn 13, Issue 3, 2012, Pages 911-918

  Capen, Robert ^a   Christopher, David ^a   Forenzo, Patrick ^b   Ireland, Charles ^c   Liu, Oscar ^a   Lyapustina, Svetlana ^d   O'Neill, John ^e   Patterson, Nate ^f   Quinlan, Michelle ^b   Sandell, Dennis ^g   Schwenke, James ^h   Stroup, Walter ⁱ   Tougas, Terrence ^j  

^a MERCK RESEARCH LABORATORIES   (United States)

^b NOVARTIS PHARMA AG   (Switzerland)

^c Regulatory Affairs   (United States)

^d Pharmaceutical Practice Group   (United States)

^e Boston Scientific ^*  (United States)

^f Inspiration Biopharmaceuticals   (United States)

^g S5 Consulting   (Sweden)

^h Applied Research Consultants   (United States)

ⁱ UNIVERSITY OF NEBRASKA LINCOLN   (United States)

^j BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

more..

Author keywords

ICH method; quantile for distribution of batch shelf lives; random batch model; shelf life terminology; stability

Indexed keywords

ARTICLE; DRUG INDUSTRY; DRUG LABELING; DRUG MANUFACTURE; DRUG PACKAGING; DRUG QUALITY; DRUG STABILITY; DRUG STORAGE; METHODOLOGY; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; SHELF LIFE; STATISTICAL ANALYSIS;

DRUG STABILITY; DRUG STORAGE; PHARMACEUTICAL PREPARATIONS; TIME FACTORS;

EID: 84866118445     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-012-9815-2     Document Type: Article

References (12)

1. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Q1A(R2): Stability testing of new drug substances and products; 2003.
2. PQRI Stability Shelf Life Working Group. http://www.pqri.org/commworking/ minutes/pdfs/dptc/sslwg/Addl/2007-MBSW.pdf. Additional presentations from SSL WG are available at http://www.pqri.org/structure/wg.asp#sslwg, 2007; Accessed 27 March 2012.
3. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Q6A: specifications: test procedures and acceptance criteria for new drug substances and new drug products: Chemical Substances; 1999.
4. International Organization for Standardization. ISO 2859. Sampling procedures for inspection by attributes, parts 0-4. ISO 2859-0:1995; ISO 2859-1:1999; ISO 2859-2:1985; ISO 2859-3:1991; ISO 2859-4:2002. http://www.iso.org/iso/iso-catalogue/catalogue-tc/catalogue-detail.htm?csnumber= 7865. Accessed 18 June 2012.
5. International Organization for Standardization. ISO 3951:1989. Sampling procedures and charts for inspection by variables for percent nonconforming. http://www.iso.org/iso/iso-catalogue/catalogue-tc/catalogue-detail.htm?csnumber= 9602. Accessed 18 June 2012.
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8. Larner G, Cooper A, Lyapustina S, Leiner S, Christopher D, Strickland H, et al. Challenges and opportunities in implementing the FDA default parametric tolerance interval two one-sided test for delivered dose uniformity of orally inhaled products. AAPS PharmSciTech. 2011;12(4):1144-56.
9. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Q1E evaluation of stability data; 2004.
10. Quinlan M, Stroup W, Christopher D, Schwenke J. On the distribution of batch shelf lives. (Accepted for publication in J Biopharm Stat. 2011).
11. Quinlan M, Stroup W, Schwenke J, Christopher D. Evaluating the performance of the ICH guidelines for shelf life estimation. (Accepted for publication in J Biopharm Stat. 2011).
12. Stroup W, Quinlan, M. Alternative shelf life estimation methodologies. In JSM Proceedings, Biopharmaceutical Section. Alexandria, VA: American Statistical Association. 2010;2056-x2066.