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Book
Demonstration of comparability of human biological products, incuding therapeutic biotechnology-derived products
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Year: 1996 Publisher: Rockville, MD : U.S. Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research,

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Keywords

Biologicals


Book
Vaccinations
Authors: ---
ISBN: 0323554350 9780323554367 0323554369 9780323662109 0323662102 9780323554350 Year: 2019 Publisher: St. Louis, Missouri : Elsevier,

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Vaccines. --- Biologicals


Book
Guidance for industry : providing regulatory submissions to the Center for Biologics Evaluation and Research (CBER) in electronic format, lot release protocols.
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Year: 2007 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research,

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Biologicals --- Testing.


Book
Micro- and nanotechnology in vaccine development
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ISBN: 9780323400299 0323400299 0323399819 9780323399814 Year: 2017 Publisher: Amsterdam

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Book
Vaccinology and methods in vaccine research
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ISBN: 0323911463 0323914381 9780323914383 9780323911467 Year: 2022 Publisher: London, England ; San Diego, California : Elsevier,

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"Vaccinology and Methods in Vaccine Research is a combination of cutting-edge methodologies, experimental approaches and literature reviews. The book covers all aspects of vaccine development, including basic immunology (focusing on the stimulation of adaptive immunity, which is required for vaccine efficacy), approaches to vaccine design and target validation, vaccine biomanufacturer and clinical development. Existing vaccinology resources are theoretical reference books, whereas this book provides a practical handbook for use in the research lab and classroom by those working in vaccinology and training others in the field."--

Keywords

Vaccines. --- Biologicals --- Vaccines --- Vaccinology


Book
Guidance for industry : nonclinical safety evaluation of drug or biologic combinations.
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Year: 2006 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Drugs --- Biologicals --- Testing.


Book
Guidance for industry : indexing structured product labeling.
Authors: ---
Year: 2008 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research,

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Drugs --- Biologicals --- Labeling.


Book
Guidance for industry : considerations for allogeneic pancreatic islet cell products.
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Year: 2008 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research,

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Book
Guidance for industry : public availability of labeling changes in "changes being effected" supplements.
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Year: 2006 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,

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Drugs --- Biologicals --- Labeling


Book
Guidance for industry : providing clinical evidence of effectiveness for human drug and biological products.
Authors: ---
Year: 1998 Publisher: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research,

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Keywords

Drugs --- Biologicals --- Effectiveness

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