Contents

1. In Vitro/In Vivo Correlations of Pharmacokinetics, Pharmacodynamics, and Metabolism for Hematologic Growth Factors and Cytokines 1

Graham Molineux and Stephen J. Szilvassy

2. In Vitro-In Vivo Correlations of Pharmacokinetics, Pharmacodynamics, and Metabolism for Antibody Therapeutics 15

C. Andrew Boswell, Rong Deng, Kedan Lin, Wendy S. Putnam, Cherry Lei,

Frank-Peter Theil, Amita Joshi, Paul J. Fielder, and Leslie A. Khawli

3. In Vitro/In Vivo Correlations of Pharmacokinetics, Pharmacodynamics, and Metabolism for Extracellular Matrix-Binding Growth Factors 53

Matthew A. Nugent, Maria Mitsi, and Jean L. Spencer

4• Metabolic Processes at Injection Sites Affecting Pharmacokinetics, Pharmacodynamics, and Metabolism of Protein and Peptide Therapeutics 80

Randall J. Mrsny

5. Local Tissue Responses to Polymer Implants Affecting Pharmacokinetics, Pharmacodynamics, and Metabolism of Proteins and Peptides 106

James M. Anderson and William G. Brodbeck

6. Engineering as a Means to Improve the Pharmacokinetics of Injected Therapeutic Proteins 129

Mark S. Dennis, Yik A. Yeung, Henry B. Lowman, and Robert F. Kelley

7. Ophthalmic Delivery of Protein and Peptide Therapeutics; Pharmacokinetics, Pharmacodynamics, and Metabolism Considerations 163

Arto Urtti

8. Pharmacokinetic and Pharmacodynamic Aspects of Intranasal Delivery 173

Henry R. Costantino, Anthony P. Sileno, Mike Templin, Chingyuan Li,

Diane Frank, Gordon C. Brandt, and Steven C. Quay

9. Oral Delivery of Protein and Peptide Therapeutics: PK/PD and Metabolism Considerations 192

Puchun Liu and Steven Dinh

10. Drug Interaction Studies of Therapeutic Biologics: Protein and Peptide Actions and Interactions That Alter Their Pharmacokinetics, Pharmacodynamics, and Metabolism 207

Iftekhar Mahmood

11. Intersection of Pharmacogenomics with Pharmacokinetics and Pharmacodynamics 225

Cecile M. Krejsa, Emmanuel Monnet, and David Cregut

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