CLINICAL PHARMACOKINETIC REGISTRATION FILE FOR NDA AND ANDA PROCEDURES

• 31 December 1997
• journal article
• review article
• Published by Elsevier in Pharmacological Research
• Vol. 36  (6) , 425-450
• https://doi.org/10.1006/phrs.1997.0254

Abstract

Keywords

• PHARMACOKINETIC REGISTRATION FILE
• CLINICAL PHARMACOLOGY
• DRUG DEVELOPMENT
• NEW DRUG APPLICATION (NDA)
• ABRIGED NEW DRUG APPLICATION (ANDA)