Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Part I Regulatory and Manufacturing Considerations

Chapter 1: Bioequivalence Testing: Rationale and Principle

Chapter 2: Guidance for Industry

Chapter 3: Product-Specific Guidance from FDA on the Development of Compressed Dosage Forms

Chapter 4: Guidance on Formulating Compressed Solids

Part II Manufacturing Formulations

Part III Tablet Coating Formulations

Part IV Composition of Proprietary Products Approved in the United States

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• Tecnologia farmacêutica
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Sodium Starch Glycolate;cGMP compliance;HPMC;Pre-approval inspections;Hydrocodone Bitartrate;Stability and bioequivalence testing;Magnesium Stearate;Packaging commodity development;Vivo Bioavailability;Formulating drugs;Drug Product;Changes to aNDAs, and aBLAs;Inactive Ingredients;pharmaceutical manufacturing formulations;BCS Class;good manufacturing practice;Microcrystalline Cellulose;generic formulations;Croscarmellose Sodium;proprietary formulations;Aluminum Lake;Lactose Monohydrate;Colloidal Silicon Dioxide;Pregelatinized Starch;Test Drug Substance;Dibasic Calcium Phosphate;Plasma Concentration;Yellow Ferric Oxide;Hydroxypropyl Cellulose;BCS;Drug Substance;Extended Release Tablets;Red Ferric Oxide;Carnauba Wax;Sodium Stearyl Fumarate