Novel Therapeutics from Modern Biotechnology: From Laboratory to Human Testing by Dale L. OxenderNovel Therapeutics from Modern Biotechnology: From Laboratory to Human Testing by Dale L. Oxender

Novel Therapeutics from Modern Biotechnology: From Laboratory to Human Testing

EditorDale L. Oxender, Leonard E. Post

Hardcover | December 4, 1998

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While addressing the particular problems associated with several classes of biotechnology products, this book also demonstrates that the principles are the same as in the development of small new chemical entities. It begins by studying FDA regulatory expectations for biotech products, before moving on to discuss general issues common to each class of biotech drug, such as proteins, peptides, and nucleic acids. The text deals with specific biotech drugs that have successfully made it into clinical trials, and each review is written by a renowned expert in the relevant fields.
Title:Novel Therapeutics from Modern Biotechnology: From Laboratory to Human TestingFormat:HardcoverDimensions:265 pages, 9.25 × 6.1 × 0.03 inPublished:December 4, 1998Publisher:Springer Berlin HeidelbergLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:3540650253

ISBN - 13:9783540650256

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Table of Contents

Overview of Regulatory Expectations for Introducing Novel Therapies into Clinical Trials.- Preparation of Clinical Trial Supplies of Biopharmaceuticals.- Protein as Drugs: Analysis, Formulation and Delivery.- Strategies for Dealing with the Immunogenicity of Therapeutic Proteins.- Targeted Toxin Hybrid Proteins.- SB 209763 - A Humanized Monoclonal Antibody for the Prophylaxis and Treatment of Respiratory Syncytial Virus Infection.- Preclinical Development of Antisense Therapeutics.- Formulation and Delivery of Nucleic Acids.- Development of Production and Quality Control Methods of Retroviral Vectors for Human Gene Therapy.- Clinical Systems for the Production of Cells and Tissues for Human Therapy.