Application for conducting Bioavailability or Bioequivalence study
Any person or institution or organisation which intends to conduct bioavailability or bioequivalence study of a new drug or an investigational new drug in human subjects shall obtain permission for conducting bioavailability or bioequivalence study from the Central Licencing Authority by making an application in Form CT-05. The Central Licencing Authority may, after scrutiny of […]
Regulation for Conducting trial for New Drug in India
Definition: ) “academic clinical trial” means a clinical trial of a drug already approved for a certain claim and initiated by any investigator, academic or research institution for a new indication or new route of administration or new dose or new dosage form, where the results of such a trial are intended to be used […]
Registration of Clinical Research Organization
Definition: ‘Clinical Research Organisation’ means any commercial or academic or any other category of body ownedby an individual or an organization having the status of a legal entity by whatever name called, which is engagedin conducting clinical trials; Assign or transfer related functions, duties and/or commitments, provided thatcontractual transfers or commitments are to be transferred […]