Data required to be submitted by an applicant for conduct of clinical trial of an approved new drug with new claims, namely, new indication or new dosage form or new route of administration or new strength

Data to be submitted along with application to conduct clinical trial or import or manufacture of a Phytopharmaceutical drug in the country (India)

Data generated by Applicant:

Data required to be submitted by an applicant forconduct of clinical trial of an approved new drug with new claims, namely, new indication or new dosage form or new route of administration or new strength

Data required to be submitted by an applicant for grant of permission to import or manufacture a new drug already approved in the country

Data to be submitted along with the application to conduct clinical trials or import or manufacture of new drugs for sale in the country

Stability testing of new drugs

Stability testing is to be performed to provide evidence on how the quality of a drug substance or formulation varies with time under the…