Contents

Foreword v

Preface vii

Contributors xv

Part I History and Basic Principles

1. Introduction to Drug Development and Regulatory Decision-Making 1 Lawrence J.Lesko and Chandrahas Sahajwalla

2. Evolution of Drug Development and its Regulatory Process 13 Henry J.Malinowski and Agnes M.Westelinck

3. Regulatory Bases for Clinical Pharmacology and Biopharmaceutics Information in a New Drug Application 35 Mehul Mehta and John Hunt

4. New Drug Application Content and Review Process for

Clinical Pharmacology and Biopharmaceutics 71

Chandrahas Sahajwalla, Veeneta Tandon, and Vanitha J.Sekar

Part II In Vitro/Pre-Clinical

5. In-vitro Drug Metabolism Studies During Development of

New Drugs 87

Anthony Y.H.Lu and Shiew-Mei Huang

6. Drug Transporters 111 Xiaoxiong Wei and Jashvant D.Unadkat

7. Principles, Issues, and Applications of Interspecies Scaling 137 Iftekhar Mahmood

Part III Clinical Pharmacology

8. Analytical Method Validation 165 Brian P.Booth and W.Craig Simon

9. Studies of the Basic Pharmacokinetic Properties of a Drug:

A Regulatory Perspective 187

Maria Sunzel

10. Surrogate Markers in Drug Development 213 Jürgen Venitz

11. Population Pharmacokinetic and Pharmacodynamic Analysis 229 Jogarao V.S.Gobburu

12. Scientific and Regulatory Considerations for Studies in Special Population 245

Chandranas Sahajwalla

13. Conducting Clinical Pharmacology Studies in Pregnant and Lactating Women 267

Kathleen Uhl

14. Scientific, Mechanistic, and Regulatory Issues with Pharmacokinetic Drug-Drug Interactions 297 Patrick J.Marroum, Hilde Spahn-Langguth, and

Peter Langguth

15. Assessing the Effect of Disease State on the Pharmacokinetics of the Drug 345

Marie Gärdmark, Monica Edholm, Eva Gil-Berglund, Carin Bergquist, and Tomas Salmonson

16. Clinical Pharmacology Issues Related to Specific Drug

Classes During Drug Development 373

Kellie Schoolar Reynolds, Vanitha J.Sekar, and Suresh Doddapaneni

Part IV Biopharmaceutics

17. Issues in Bioequivalence and Development of Generic

Drug Products 399

Barbara M.Davit and Dale P.Conner

18. Regulatory Considerations for Oral Extended Release Dosage Forms and in vitro (Dissolution)/in vivo (Bioavailability) Correlations 417 Ramana S.Uppoor and Patrick J.Marroum

19. In vivo Bioavailability/Bioequivalence Waivers 449 Patrick J.Marroum, Ramana S.Uppoor, and Mehul U.Mehta

20. Bioavailability and Bioequivalence Issues for Drugs Administered via Different Routes of Administration; Inhalation/Nasal Products; Dermatological Products, Suppositories 475 Edward D.Bashaw

Part V Contemporary and Special Interest Topics

21. Scientific and Regulatory Issues in Development of Chiral

Drugs 503

Chandrahas Sahajwalla, Jyoti Chawla, and Indra K.Reddy

22. A Regulatory View of Liposomal Drug Product Characterization 525 Kofi Kami and Brian P.Booth

23. Challenges in Drug Development: Biological Agents of Intentional Use 535 Andrea Meyerhoff

24. The Regulation of Antidotes for Nerve Agent Poisoning 543 Russell Katz and Barry Rosloff

25. Bioequivalence Assessment: Approaches, Designs, and

Statistical Considerations 561

Rabindra N.Patnaik

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