OVERVIEW OF CLINICAL TRIALS FOR NEW DRUG SAFETY AND EFFICACY


Mr. Avinash D. Hatkar, Mr. Shrikant Rushindar Katkade, Ms. Pooja Mule, Dr. Sunil Jaybhaye, Mr. Saurabh Bondre
Pharmacy, Department Dr. Babsaheb Ambedkar Technological University, Raigad, Lonere, Maharashtra
Abstract
Clinical trials is a testing research of a new drug safety and efficacy. Pre-clinical studies starts before clinical trials. In pre-clinical trial may look at whether a drug is safe or the side effects it causes; later trials aim to test whether a new treatment is better than existing treatment. Clinical trials study on different phases that are phase 0, 1,2,3,4. Main purpose of phase 0 to help speed up and streamline the drug approved the process. In phase 1 trials to find out about closes and side effects. A phase 2 clinical trial is to evaluate the effectiveness and safety of a new drug or drug combination for a particular indication. Then in phase 3 study that tests the safety and how well a new treatment works compared with a standard treatment. The main objective of phase 4 trials is to check the drug's performance in real life scenarios. The Phase 4 studies include all studies performed after drug approved and related to the approved indication
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Journal Name :
EPRA International Journal of Research & Development (IJRD)

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Published on : 2024-11-28

Vol : 9
Issue : 11
Month : November
Year : 2024
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