REVALIDATION OF IN-VITRO SPECIFICATION LIMITS FOLLOWING AN IN-VITRO IN-VIVO CORRELATION

Authors
PABST G
Citation
G. Pabst, REVALIDATION OF IN-VITRO SPECIFICATION LIMITS FOLLOWING AN IN-VITRO IN-VIVO CORRELATION, Arzneimittel-Forschung, 48(5A), 1998, pp. 584-588
Citations number
7
Categorie Soggetti
Pharmacology & Pharmacy","Chemistry Medicinal",Chemistry
Journal title
Arzneimittel-Forschung → ACNP
ISSN journal
00044172
Volume
48
Issue
5A
Year of publication
1998
Pages
584 - 588
Database
ISI
SICI code
0004-4172(1998)48:5A<584:ROISLF>2.0.ZU;2-B
Abstract
A ''Level A'' in vitro/in vivo correlation was established for a susta ined release theophylline (CAS 58-55-9) preparation (Bronchoretard(R)) under investigation. Such a functional relationship is a valuable too l for predicting the in vivo performance of a product. Additionally, t he in vitro specification limits could be justified or even enlarged b ased on such an extrapolation.