Rational approaches to specifications setting: An opportunity for harmonization

Pharmaceutical Technology

Volumn 20, Issue 9, 1996, Pages 110-118

  Davis, Gregory C ^a   Murphy, John R ^e   Weisman, Doris A ^c   Andersen, Scott W ^d   Hofer, Jeffrey D ^b  

^a ELI LILLY AND COMPANY   (United States)

^b Stat and Math Sciences Department

^c Biosynthetic Tech Services Group   (United States)

^d Lilly Pharmaceutical Quality Control

^e NONE

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DRUG MANUFACTURE; GOOD MANUFACTURING PRACTICE;

EID: 0029832735     PISSN: 01478087     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (6)

1. International Conference on Harmonization, "Harmonized Tripartite Guidelines: Stability Testing of New Drug Substances and Products," Step 5 Document (effective 1 January 1998).
2. United States of America v. Barr Laboratories, Inc., Civil Action No. 92-1744, United States District Court for the District of New Jersey (1993).
3. Council Directive 83/570/EEC (26 October 1983) amending the Annex to Council Directive 75/318/EEC (20 May 1975), Part 1(E)(2).
4. United States Pharmacopeia 23 (1995).
5. P. Allen, G. Dukes, and M. Gerger, "Determination of Release Limits: A General Methodology," Pharm. Res. 8 (9), 1210-1213 (1991).
6. J. Grimes and L. Foust, "Establishing Release Limits with a Random Slopes Stability Model," 1994 Proc. Biopharm. Sec. Am. Stat. Assoc. (American Statistical Association, Alexandria, VA).