Common reasons for "for-cause" inspections in bioequivalence studies submitted to the Food and Drug Administration.
AAPS J
; 15(1): 10-4, 2013 Jan.
Article
em En
| MEDLINE
| ID: mdl-23054974
ABSTRACT
"For-cause" inspections are initiated during the review of bioequivalence (BE) data submitted to Abbreviated New Drug Applications when possible scientific misconduct and study irregularities are discovered. We investigated the common reasons for initiating "for-cause" inspections related to the clinical, analytical, and dissolution study sites associated with BE studies. This information may help the pharmaceutical industry to understand the root causes of compliance failures in BE studies and help them to improve compliance with FDA's regulations, thereby facilitating more rapid approval of safe and effective generic drugs.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Equivalência Terapêutica
Idioma:
En
Ano de publicação:
2013
Tipo de documento:
Article