Clinical Pharmacology: Current Topics and Case Studies

This revised and extended second edition focuses on current and emerging topics in drug development, their molecular mechanisms of action as well as regulatory issues. In addition, in-depth insights into clinical drug research and trial methodology are presented on the basis of concrete case studies. This updated book makes a valuable contribution to the field of Clinical Pharmacology and serves as a must-have guide for professors, researchers and advanced students from academia and pharmaceutical industry. 

Table of contents (23 chapters):

The Discipline of Clinical Pharmacology

Pages 3-6

Müller, Markus

Current Issues in Drug Development

Pages 7-18

Müller, Markus

Current Issues in Drug Regulation

Pages 19-31

Wirthumer-Hoche, Christa (et al.)

Current Topics in Drug Reimbursement

Pages 33-48

Bucsics, Anna (et al.)

Ethics in Clinical Research

Pages 51-60

Singer, Ernst (et al.)

Good Clinical Practice (GCP) and Scientific Misconduct

Pages 61-84

Bloechl-Daum, Brigitte

Phase I Studies and First-In-Human Trials

Pages 85-95

Derhaschnig, Ulla (et al.)

Clinical Trials: Interventional Studies

Pages 97-107

Wolzt, Michael (et al.)

Observational Studies

Pages 109-136

Herkner, Harald (et al.)

Tools in Clinical Pharmacology: Imaging Techniques

Pages 139-150

Bauer, Martin (et al.)

Pharmacokinetics II:

Pages 151-160

Lappin, Graham

Current Concepts of Pharmacogenetics, Pharmacogenomics, and the “Druggable” Genome

Pages 161-183

Schmidt, Wolfgang M. (et al.)

Pharmacokinetics I: PK-PD Approach, the Case of Antibiotic Drug Development

Pages 185-217

Sy, Sherwin K. B. (et al.)

Epidemiology and Biostatistics

Pages 219-232

Garhöfer, Gerhard (et al.)

Placebo Effects and Placebo Control in Clinical Trials

Pages 233-243

Pleiner-Duxneuner, Johannes

Pharmaceutical Drug Safety

Pages 247-263

Brunner, Martin

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Drug Interactions

Pages 265-292

Zeitlinger, Markus

Development of Advanced Therapy Medicinal Products: A Case for Early Scientific Advice

Pages 293-303

Brunner, Martin (et al.)

Biologics

Pages 305-315

Jilma, Bernd (et al.)

Generics, Biosimilars, Enantiomers, and Me-Toos

Pages 317-336

Deforce, Dieter (et al.)

Orphan Drugs for Rare Diseases

Pages 337-360

Bloechl-Daum, Brigitte (et al.)

Special Situations, Market Fragmentation II: Sex Differences

Pages 361-375

Gouya, Ghazaleh, MD

Special Situations III: Medicines for Children

Pages 377-392

Male, Christoph