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):
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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
\
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
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