DrugsApproval

Rules that Drug Needs To Be Agree

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Why This roles?

-To Evaluate Drugs.- Provides Information to use the medicine wisely.

Note:-An important use of a drug may also be discovered by

accident.EX: Retrovir

STEPS OF APPROVAL

Animal Testing

IND:-- outlines what the sponsor of a new drug proposes for human testing in clinical trials.- Sponsors must show:The result of Preclinical testing.Proposes to do for human testing.

Phase 1 Testing:-- Clinical Trials begin after IND is reviewed.- conducted on Healthy Volunteers (20-80)- IRBs approve the clinical trial protocols.- IRBs make sure that:** study is acceptable.** participants have given consent and are fully informed of their risks.** researchers take appropriate steps to protect patients from harm.- This step to study:- (safety)** Side Effects.** Metabolism and Excretion of the drug.

Phase 2 Testing:-

- The aim of this study: (effectiveness)** preliminary data on whether the drug works in people who have a certain disease- Number of subjects ranges from few dozens to about 300.- They are compared with patients receiving different drug.- At the end of the phase FDA meets with a sponsor .

Phase 3 Testing:-- studies gather more information about safety and effectiveness.- studying different populations and different dosages and using the drug in combination with other drugs.- Number of subjects ranges from several hundred to about 3000 people. Review Meeting:-- gather additional information about a product's safety, efficacy, or optimal use.- Postmarketing.

NDA:-- Formal step.- includes all animal and human data and analyses of the data, as well as information about how the drug behaves in the body and how it is manufactured.

Application Reviewed:-- 60 days to decide whether to file it so that it can be reviewed. The FDA can refuse to file an application that is incomplete.

-A team of physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling.

Drug Labeling. Facility Inspection:-- FDA inspects the facilities where the drug will be manufactured. Drug Approval:-- FDA reviews will approve the application or issue a response letter.