A manufacturer or a person or a party who wants to proceedwith commercialization and selling of a product.
Food and Drug authority.
Centre for drug evaluation and research (USA).
Central Drug Standardisation and Control Organisation (India).
A person or a team which plans, coordinates and gets aclinical study of new drugs on humans executed.
Initial pharmacological studies done on animals tofind efficacy, safety and toxicity and whether they can be utilized forhuman studies.
Pharmacological studies done on limitednumber of human volunteers after a positive preclinical report, to findefficacy, safety and toxicity on human use and establish dosage regimenand treatment methods.