Novel therapeutics from modern biotechnology : from laboratory to human testing /
This volume addresses the particular problems associated with several classes of biotechnology products, and at the same time demonstrates that the principles are the same as in the development of small new chemical entities. The first chapter addresses FDA regulatory expectations for biotech produc...
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| Other Authors: | , |
| Format: | eBook |
| Language: | English |
| Published: |
Berlin ; New York :
Springer,
[1999]
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| Edition: | Springer study ed. |
| Subjects: | |
| Online Access: | Connect to the full text of this electronic book |
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.