Protein Pharmacokinetics and Metabolism

1. Front Matter

   Pages i-xvi

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2. Goals and Analytical Methodologies for Protein Disposition Studies

   • Bobbe L. Ferraiolo, Marjorie A. Mohler

   Pages 1-33

3. Binding Proteins of Protein Therapeutics

   • Marjorie A. Mohler, Jennifer E. Cook, Gerhard Baumann

   Pages 35-71

4. Potential Effects of Antibody Induction by Protein Drugs

   • Peter K. Working

   Pages 73-92

5. Pharmacokinetics and Metabolism of Protein Hormones

   • Jerome A. Moore, Victor J. Wroblewski

   Pages 93-126

6. Pharmacokinetics and Metabolism of Therapeutic Cytokines

   • Carol A. Gloff, Robert J. Wills

   Pages 127-150

7. Pharmacokinetics and Metabolism of Cardiovascular Therapeutic Proteins

   • Paul A. Cossum, Robert A. Baughman Jr.

   Pages 151-187

8. Pharmacokinetics and Metabolism of Hematopoietic Proteins

   • John B. Stoudemire

   Pages 189-222

9. Pharmacokinetics and Metabolism of Therapeutic and Diagnostic Antibodies

   • John M. Trang

   Pages 223-270

10. Back Matter

    Pages 271-275

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Investigation of the pharmacokinetics and metabolism of human proteins has escalated over the last two decades because of the use of recombinant human proteins as therapeutic agents. In addition, the development and improvement of analytical techniques enabling the detection of minute quantities of proteins in biological matrices have aided this process. In assembling this volume, we sought to provide a state-of-the-art as­ sessment of the pharmacokinetics and metabolism of protein therapeutics through complete reviews of selected examples. A comprehensive review of all protein therapeutics was not attempted; the majority -of the therapeutic protein classes and crucial scientific issues have been addressed, however. Therefore, we are confident that this volume will provide a useful reference for scientists in this field. The volume has been divided into two general parts. The first part (Chapters 1-3) is composed of general reviews of topics of importance in pharmacokinetic/metabolism studies of proteins: goals and analytical meth­ odologies, effects of binding proteins, and effects of antibody induction, respectively. The second part (Chapters 4-8) consists of specific, detailed reviews by therapeutic protein class: growth factors and hormones, cyto­ kines, cardiovascular proteins, hematopoietic proteins, and antibodies, respectively. The editors are grateful to the contributors for the patience, personal sacrifice and perseverance required to complete this volume. BoDDE L. FERRAIOLO MARJORIE A. MOHLER CAROL A. GLOFF ix Contents Chapter 1 Goals and Analytical Methodologies for Protein Disposition Studies Bobbe L. Ferraiolo and Marjorie A. Mohler 1. Introduction ................................................. .

• biotechnology
• cytokine
• cytokines
• drugs
• interferon
• kinetics
• metabolism
• pharmacokinetics
• protein
• research

• R. W. Johnson Pharmaceutical Research Institute, Spring House, USA

  Bobbe L. Ferraiolo

• Genentech, Inc., South San Francisco, USA

  Marjorie A. Mohler

• Alkermes, Inc., Cambridge, USA

  Carol A. Gloff

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