Focusing on the three most critical components that successfully bring an API to market-process development, manufacturing, and governmental regulation and approval-this reference serves as a step-by-step guide to the planning and clear understanding of the bulk manufacturing of APIs. It offers current and timely discussions of the process development cycle, design engineering, the approval process, quality control and assurance, and validation, as well as plant manufacturing activities including materials management, maintenance, and safety. Filling a gap in the literature, this guide covers all the essential information required to effectively plan and execute manufacturing APIs.
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First Sentence:
Pharmachemical manufacturing is that branch of fine chemical manufacturing that is directed to the manufacture of chemicals whose ultimate use will be in a final pharmaceutical dosage form, referred to as the active pharmaceutical ingredient ("API"). Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
bulk drug process development, thermochemical safety, drug pilot plant, project execution strategy, investigational application, kilo lab, process development function, pilot plant environment, preparative effort, preparative task, process development task, process design function, effort plane, new drug approval process, bulk pharmaceutical chemicals, dosage form development, physicochemical attributes, preparative stage, process development effort, bulk drugs, first manufacture, process development team, preliminary scope, processing envelope, preapproval inspections Key Phrases - Capitalized Phrases (CAPs): (learn more)
United States, New York, New Jersey, International Conference, Development Phase, Rosas Figure, Apics Series, Business One Irwin, European Pharmacopoeia, Logistics Series, Oxford University Press, Pharmaceutical Sci Technol, Professional Development Series New!
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Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Pharmachemical manufacturing is that branch of fine chemical manufacturing that is directed to the manufacture of chemicals whose ultimate use will be in a final pharmaceutical dosage form, referred to as the active pharmaceutical ingredient ("API"). Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
bulk drug process development, thermochemical safety, drug pilot plant, project execution strategy, investigational application, kilo lab, process development function, pilot plant environment, preparative effort, preparative task, process development task, process design function, effort plane, new drug approval process, bulk pharmaceutical chemicals, dosage form development, physicochemical attributes, preparative stage, process development effort, bulk drugs, first manufacture, process development team, preliminary scope, processing envelope, preapproval inspections Key Phrases - Capitalized Phrases (CAPs): (learn more)
United States, New York, New Jersey, International Conference, Development Phase, Rosas Figure, Apics Series, Business One Irwin, European Pharmacopoeia, Logistics Series, Oxford University Press, Pharmaceutical Sci Technol, Professional Development Series New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Citations (learn more)
This book cites 100
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2
books
cite this book:
- New Drug Approval Process, Fourth Edition, Accelerating Global Registrations (Drugs and the Pharmaceutical Sciences) by Richard Guarino on 4 pages
- Drug Stability: Principles and Practices (Drugs and the Pharmaceutical Sciences) by Jens T. Carstensen in Front Matter (1), Front Matter (2), and Front Matter (3)
- Pharmaceutical Process Validation: An International Third Edition (Drugs and the Pharmaceutical Sciences) by Robert A. Nash in Front Matter (1), Front Matter (2), and Front Matter (3)
- Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms (Drugs and the Pharmaceutical Sciences) by James McGinity in Front Matter (1), and Front Matter (2)
- Clinical Drug Trials and Tribulations, Second Edition, (Drugs and the Pharmaceutical Sciences) by Cato in Front Matter (1), and Front Matter (2)
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