Similar to 薬事承認

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

Clinical trial

New Drug Application

PDUFA date

Investigational New Drug

Placebo

Drug discovery

Human equivalent

Bioprospecting

Xanomeline/trospium chloride

Iclepertin

NBI-1117568

Bitopertin

Pesampator

Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices

Dry heat sterilization

Robert Baratz

Toxicology

Pharmacopoeia