UNIT 5 REGULATORY SCIENCE - Copy.pptx

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PRADUM KUMAR

Regulatory concept.

Education

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1. Introduction During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies. 2. Drug development team 3. Investigational new drug application (INDA) 4. Format and content of IND 5. Preclinical testing 6. The development process IND application and safety 7. Clinical research 8. New drug application 9. Abbreviated new drug application 10. Changes to an approved NDA or ANDA 11. Difference between NDA and ANDA

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 DRUG MASTER FILE  Presented by :  RUSHIKESH D MENDHE  Roll no - 511  Mpharm Ist Year  (Department of Pharmaceutics)  Content : :  INTRODUCTION  TYPES OF DMF  DMF FORMAT & ASSEMBLY  DELIVERY OF DMF TO FDA  SUBMISSION OF DMF  THE MECHANISM OF A DRUG MASTER FILE  CTD & ELECTRONIC DMFS  UPDATES TO DMF  CLOSURE OF A DRUG MASTER FILE  APPLICATION OF DMF  REFERENCE  INTRODUCTION :  A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.  This guideline does not impose mandatory requirements.  Objectives :  Main Objective of the DMF is to support regulatory requirements  To prove the quality, safety and efficacy of the medicinal product  TYPES OF DMF :  DMF FORMAT & ASSEMBLY :  The DMF is submitted as Original and Duplicate jackets, collated, assembled, paginated, and jacketed, using covers obtained from the government printing office and a respecifically provided for the DMFs  Multiple volumes are numbered, and the paper must be standard paper size  Paper length should not be less than 10 inches nor more than 12 inches.  Each volume of a DMF should be not more than 2 inches thick  DELIVERY OF DMF TO FDA :  DMF should be submitted at following address :  Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901 – B Ammendale Road Beltsville, MARYLAND 20705-1266 USA  SUBMISSION OF DMF :  The DMF must be submitted in two copies, one with a blue cover and one with a red cover.  Each page of each copy of the DMF should be dated and consecutively numbered.  Each DMF submission should contain : • A Transmittal letter • Administrative information about the submission • Other specific information A. Transmittal Letter : i) Original Submissions : • Identification of submission: Original, the type of DMF as classified in Section III, and its subject. • Identification of the applications, if known, that the DMF is intended to support, including the name and address of each sponsor, applicant, or holder, and all relevant document numbers. • Signature of the holder or the authorized representative. • Typewritten name and title of the signer. ii) Ammendments : • Identification of submission: Amendment, the DMF number, type of DMF, and the subject of the amendment. • A description of the purpose of submission, e.g., update, revised formula, or revised process. • Signature of the holder or the authorized representative. • Typewritten name and title of the signer. B. Administrative information about the submission:

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Schedule y

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DEVELOPING CLINICAL TRIAL PROTOCOL BY PRANAV LENDHEY.pptx

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