DDS 1 Notes PDF

# NEW DRUG DEVELOPMENT ## General Requirements for FDA Approval 1. Demonstrated safety and efficacy. 2. Demonstrated process control and validation. ## The Drug Development Process - **Biological Characterization** - Pharmacodynamics - Investigates the biochemical and physiological effects...

# NEW DRUG DEVELOPMENT ## General Requirements for FDA Approval 1. Demonstrated safety and efficacy. 2. Demonstrated process control and validation. ## The Drug Development Process - **Biological Characterization** - Pharmacodynamics - Investigates the biochemical and physiological effects of drugs. - Toxicology - Investigates the potential for adverse or undesired effects. - **Clinical Trials** - Phase 1 - Mainly Safety and dosage. - Phase 2 - Mainly effectiveness, but also short-term safety. - Phase 3 - Confirm effectiveness, longer-term safety. - **Preformulation Studies** - Integrated with knowledge gained from ADME studies. - Used for the rational development of stable, safe, and effective dosage forms. ## Investigational New Drug Application (IND) - Must be filed with the FDA before human testing. - Defines all aspects including animal studies, manufacturing info, and clinical plan. - Reviewed by experts. - The application is forwarded to a specific division within the FDA. ## Final Product Development - During clinical studies, the final formulation is completed as well as the packaging and labeling. ## New Drug Application (NDA) - A complete and organized presentation of pre-clinical and clinical data with summaries of human pharmacokinetics, bioavailability, microbiology (for antibiotics), a discussion of the benefits and risks of the drug's usage, and a complete proposed product labeling. - Prior to final approval, the manufacturing facilities must be inspected to assure its capability to comply with quality standards. ## Post-marketing - Following approval, the drug product is continually monitored in clinical investigations to learn more about the drug. - Adverse Reaction Reporting from physicians and pharmacists. - Comprehensive annual reports are also required. ## Variations in the Drug Development Process ### Orphan Drugs - Drug used to treat a rare disease or condition. - FDA response is usually within 60 days. ### Expanded Access - To facilitate getting the drugs to these patients outside of a clinical trial. ### Abbreviated New Drug Application - NDA for generic drug approval. ### Supplemental New Drug Application - For changes in labeling, method of synthesis, ## Expedited Programs for Serious Conditions ### Fast Track - For a serious condition and nonclinical or clinical data demonstrate the potential to fill an unmet medical need. ### Breakthrough Therapy - FDA takes actions to expedite development. ### Accelerated Approval - For a serious condition that fills an unmet medical need to be approved based on a surrogate endpoint. ### Priority Review - For a drug that appears to represent an advance over available therapy. ## Time and Cost of New Drug Approval - **Preclinical Rand D** - **Phase 1** - **Phase 2** - **Phase 3** - **NDA Submission** ## A good database for FDA approved drugs can be found at Drugs@FDA: FDA-Approved Drugs