Completely updated and enlarged to three volumes, the second edition of Pharmaceutical Dosage Forms: Parenteral Medications examines every important aspect of sterile drug products. Volume 3 offers comprehensive coverage of medical devices, quality assurance, and regulatory issues. It discusses regulatory requirements in record-keeping, places special emphasis on methods of detecting, counting and sizing particles, and offers new perspectives on contemporary validation concepts and how they affect the validation process. It also explains current FDA enforcement activities, the voluntary compliance policy, select court cases, and how these relate to parenterals.
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. . .a valuable compilation of the current situation in regulatory issues as well as some of the technical problems associated with parenteral drug production.
---Pharmaceutical Technology
---Pharmaceutical Technology
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Inside This Book
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First Sentence:
Quality assurance has as its objective the measurement of product attributes to ensure that the product being manufactured conforms to its specifications. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
parenteral devices, parenteral drug manufacturers, new drug section, parenteral drug manufacturing, terminal sterilization cannot, gas sterilization processes, mouse safety test, nonviable airborne particles, parenteral drug industry, component mapping studies, penetration thermocouples, parenteral manufacturing process, periodic evaluation reports, product sterility test, ultraclean water, empty chamber studies, parenteral industry, reject zone, dose setting methods, overkill cycles, dosimetric release, parenteral drug products, bioburden reduction, injectable drug products, bioburden organisms Key Phrases - Capitalized Phrases (CAPs): (learn more)
United States, Federal Register, Cosmetic Act, Code of Federal Regulations, New York, Federal Food, Drug Assoc, Supreme Court, Knapp Figure, Government Printing Office, National Formulary, Marcel Dekker, Orphan Drug Act, Superintendent of Documents, Validation of Aseptic Pharmaceutical Processes, Particle Atlas, Administrative Procedure Act, Freedom of Information Act, New Brunswick, New Jersey, Public Law, Regulatory Procedures Manual, Ann Arbor, Bureau of Drugs, Fishers Lane New!
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Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Quality assurance has as its objective the measurement of product attributes to ensure that the product being manufactured conforms to its specifications. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
parenteral devices, parenteral drug manufacturers, new drug section, parenteral drug manufacturing, terminal sterilization cannot, gas sterilization processes, mouse safety test, nonviable airborne particles, parenteral drug industry, component mapping studies, penetration thermocouples, parenteral manufacturing process, periodic evaluation reports, product sterility test, ultraclean water, empty chamber studies, parenteral industry, reject zone, dose setting methods, overkill cycles, dosimetric release, parenteral drug products, bioburden reduction, injectable drug products, bioburden organisms Key Phrases - Capitalized Phrases (CAPs): (learn more)
United States, Federal Register, Cosmetic Act, Code of Federal Regulations, New York, Federal Food, Drug Assoc, Supreme Court, Knapp Figure, Government Printing Office, National Formulary, Marcel Dekker, Orphan Drug Act, Superintendent of Documents, Validation of Aseptic Pharmaceutical Processes, Particle Atlas, Administrative Procedure Act, Freedom of Information Act, New Brunswick, New Jersey, Public Law, Regulatory Procedures Manual, Ann Arbor, Bureau of Drugs, Fishers Lane 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 15
books:
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100
books
cite this book:
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- Pharmaceutical Dosage Forms: Disperse Systems, Volume 3 by Herbert Lieberman on 5 pages
- Disinfection, Sterilization, and Preservation by Seymour S Block on page 65, page 523, and page 524
- Validation of Aseptic Pharmaceutical Processes by Frederick J. Carleton on page 65, page 286, and page 287
- Health and Safety (Statutory Instruments) by The Stationery Office on page 359
- Juran's Quality Control Handbook by J.M. Juran on page 421
See all 15 books this book cites
- Pharmaceutical Dosage Forms: Disperse Systems, Volume 3 by Herbert Lieberman on 8 pages
- Advanced Pharmaceutical Solids (Drugs and the Pharmaceutical Sciences) by Jens T. Carstensen on 7 pages
- Pharmaceutical Dosage Forms by Herbert Lieberman on 6 pages
- Encyclopedia of Pharmaceutical Technology (Pharmaceutical Technology Encyclopedia) by James Swarbrick on 6 pages
- Pharmaceutical Dosage Forms: Parenteral Medications, Volume 2 by Kenneth E. Avis on 6 pages
See all 100 books citing this book
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