Contents

xi xiii xv xvii

5 Pharmacology, Toxicology, Therapeutic Dosage Formulations, and Clinical Response 97

5.1. Clinical Pharmacology 98

5.2. Dose and Therapeutic Response 116

5.3. Dosage Form and Routes of Administration 118

THERAPEUTICS BASED ON BIOTECHNOLOGY 125

6 Hematopoietic Growth Factors and Coagulation Factors 127

6.1. Overview 128

6.2. Monographs 136

7 Interferons and Cytokines for Anti-infective and Cancer Therapy 161

7.1. Interferons in Cancer Therapy Mamta Chawla-Sarkar, Paul Masci, and Ernest Borden 161

7.2. Interferons in Viral Hepatitis Gary L. Davis 179

7.3. Interferon-b in the Treatment of Multiple Sclerosis 185

7.4. Monographs 188

8 Hormones 209

8.1. Protein Hormones as Therapeutics: Yesterday, Today, and Tomorrow 209 Sandra Blethen

8.2. Monographs 215

9 Enzymes 245

9.1. Overview of Enzyme Therapies 245

9.2. Monographs 256

10 Antibodies and Derivatives 271

10.1. Overview 271

10.2. Monographs 289

11 Vaccines 313

Shiu-Lok Hu and Rodney J.Y. Ho

11.1. Why Vaccines? 313

11.2. How Do Vaccines Work? 314

11.3. Traditional Vaccine Approaches 315

11.4. Subcellular and Recombinant Subunit Vaccines 318

11.5. Future Directions 321

11.6. Summary 323

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