Biotechnology represents a novel and expanding international industry bound by new and ever-changing legislature. This text provides a comprehensive overview of product-specific, international and country-specific licensing requirements and general regulatory issues in biotechnology.
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Biotechnology represents a novel and expanding international industry bound by new and ever-changing legislature. This text provides a comprehensive overview of product-specific, international and country-specific licensing requirements and general regulatory issues in biotechnology.
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Inside This Book
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First Sentence:
Effective development of novel biotechnology products has been facilitated by preexisting regulatory systems used for older conventional products such as plasma-derived proteins and vaccines prepared by fermentation or cell culture technology. Read the first page Key Phrases - Capitalized Phrases (CAPs): (learn more)
United States, New York, Federal Register, Code of Federal Regulations, Marcel Dekker, Methods Enzymol, National Institutes of Health, World Health Organization, Rockville Pike, Cold Spring Harbor, Advisory Committee, Pharmaceutical Technology, Characterization of Cell Lines, Comprehensive Biotechnology, Pass Pass, American Chemical Society, Boca Raton, Genetics Institute, Actions Under Guidelines, Large Volume Parenterals, National Academy of Sciences, National Research Council, Public Health Service Act, San Francisco, Biological Standardization New!
Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Effective development of novel biotechnology products has been facilitated by preexisting regulatory systems used for older conventional products such as plasma-derived proteins and vaccines prepared by fermentation or cell culture technology. Read the first page Key Phrases - Capitalized Phrases (CAPs): (learn more)
United States, New York, Federal Register, Code of Federal Regulations, Marcel Dekker, Methods Enzymol, National Institutes of Health, World Health Organization, Rockville Pike, Cold Spring Harbor, Advisory Committee, Pharmaceutical Technology, Characterization of Cell Lines, Comprehensive Biotechnology, Pass Pass, American Chemical Society, Boca Raton, Genetics Institute, Actions Under Guidelines, Large Volume Parenterals, National Academy of Sciences, National Research Council, Public Health Service Act, San Francisco, Biological Standardization New!
Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Citations (learn more)
This book cites 46
books:
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7
books
cite this book:
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- Advances in Animal Cell Biology and Technology for Bioprocesses by R. E. Spier on 4 pages
- Encyclopedia of Pharmaceutical Technology: Volume 19 - Blood Substitutes: Hemoglobin-based Oxygen Carriers to Tablet Evaluation Using Near-Infrared ... 2) (Pharmaceutical Technology Encyclopedia) by James Swarbrick on page 61, page 456, and page 457
- Drug Biotechnology Regulation (Biotechnology and Bioprocessing) by Y. Chiu on page 200, and page 380
- Large-scale Mammalian Cell Culture Technology (Biotechnology and Bioprocessing) by Lubiniecki on page 60, and page 198
- Large Scale Cell Culture Technology by Bjorn K. Lydersen on page 442, and page 443
See all 46 books this book cites
- Development of Biopharmaceutical Parenteral Dosage Forms (Drugs and the Pharmaceutical Sciences) by Bontempo on page 29
- Antibody Therapeutics (Pharmacology and Toxicology) by William J. Harris on page 214
- Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies (Biotechnology and Bioprocessing Series) by Anurag S. Rathore on page 390
- Animal Cell Biotechnology: Methods and Protocols (Methods in Biotechnology) by Nigel Jenkins on page 8
- Biopharmaceuticals: Biochemistry and Biotechnology by Gary Walsh on page 40
See all 7 books citing this book
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