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Investigational New Drugs (INDs) Phase 1CMC Issues,[object Object]
2,[object Object],Primary Objectives of IND,[object Object],Phase 1: Safety,[object Object],Initial introduction of a new drug into humans,[object Object], Closely monitored, patients or normal volunteers ,[object Object],Metabolism and pharmacological actions of drug in humans ,[object Object],Side effects associated with increasing doses,[object Object],Early evidence of effectiveness,[object Object],Design of well-controlled, scientifically valid phase 2 studies,[object Object],Phase 2: Limited well controlled clinical studies ,[object Object],Phase 3: Expanded well controlled and uncontrolled clinical trials ,[object Object]
3,[object Object],IND Content and Format,[object Object],21 CFR 312,[object Object],21 CFR 312.21: Phases of an Investigation,[object Object],Phase I, II, and III,[object Object],21 CFR 312.22: General Principles,[object Object],21 CFR 312.23: Content,[object Object],Drug Substance,[object Object],Drug Product,[object Object],Placebo,[object Object],Labeling,[object Object],Environmental Analysis,[object Object]
4,[object Object],IND Phase 1 – CMC Requirements,[object Object],The amount of information needed depends on:,[object Object],Phase of the investigation,[object Object],Novelty of the drug,[object Object],Previous studies,[object Object],Dosage form/Route of administration,[object Object],Duration of the Study,[object Object],Patient population,[object Object],Known or suspected risks,[object Object]
5,[object Object],IND Phase 1 – CMC Requirements,[object Object],• Drug Substance ,[object Object],Description (physical, chemical, biological),[object Object],Manufacturer (name and address),[object Object],Method of Preparation (brief description/ flow diagram, reagents, solvents, catalysts),[object Object],Analytical Methods  ( brief description, proposed criteria, certificates of analysis),[object Object],Stability (brief description of study/test methods, preliminary tabular data),[object Object]
6,[object Object],IND Phase 1 – CMC Requirements,[object Object],Drug Product,[object Object],Components (grade (e.g. USP/ NF, ACS), novel excipients, etc.),[object Object],Quantitative composition,[object Object],Manufacturer (name and address),[object Object],Method of Manufacture (narrative and/or flow diagrams, sterilization process for sterile products),[object Object],Analytical Methods,[object Object],brief description of test methods and limits (dosage form dependent),[object Object], Stability of Drug product,[object Object],Information to assure the product’s stability during the planned clinical studies ,[object Object]
7,[object Object],IND Phase 1 – CMC Requirements,[object Object],Placebo,[object Object],Description,[object Object],Composition and Controls,[object Object],Control,[object Object]
8,[object Object],IND Phase 1 – CMC Requirements,[object Object],Sponsor Agency Interactions,[object Object],Pre-IND Meetings:  Generally to focus on safety issues related to the identification, strength, quality, purity of the investigational drug and to identify any potential clinical hold issues,[object Object],EOP2 Meetings: Generally to focus on CMC specific issues for the planned phase 3 studies,[object Object],Pre-NDA Meetings: Generally to focus on filing and format issues,[object Object],Follow-up teleconferences and other meetings, as warranted,[object Object]
9,[object Object],  Safety Concerns,[object Object],In general, Phase 1 review of the CMC sections to ensure the identity, strength, quality, and purity of the investigational new drugs as they relate to safety,[object Object],Examples:,[object Object],Product made with unknown or impure components,[object Object],Sterility and/or apyrogenicity not assured (e.g., injectables),[object Object],Product not stable through clinical study duration,[object Object],Strength or impurity profile insufficiently defined,[object Object],Product possessing structures of known or likely toxicity,[object Object],Impurity profile indicates health hazard,[object Object],Poorly characterized master or working cell bank,[object Object]

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