Clinical Pharmacology: Current Topics and Case Studies

Part I. Introduction

1. The Discipline of Clinical Pharmacology
Markus Müller

2. Current Issues in Drug Development
Markus Müller

3. Current Issues in Drug Regulation
Christa Wirthumer-Hoche, Brigitte Bloechl-Daum

4. Current Topics in Drug Reimbursement
Anna Bucsics, Robert Sauermann, Valerie Nell-Duxneuner

Part II. Clinical Trials

5. Ethics in Clinical Research
Ernst Singer, Christiane Druml

6. Good Clinical Practice (GCP) and Scientific Misconduct
Brigitte Bloechl-Daum

7. Phase I Studies and First-In-Human Trials
Ulla Derhaschnig, Bernd Jilma

8. Clinical Trials: Interventional Studies
Michael Wolzt, Stefan Aschauer

9. Observational Studies
Harald Herkner, Christoph Male

Part III. Tools in Clinical Pharmacology

10. Tools in Clinical Pharmacology: Imaging Techniques
Martin Bauer, Oliver Langer

11. Pharmacokinetics II: 14C-Labelled Microdosing in Assessing Drug Pharmacokinetics at Phase 0
Graham Lappin

12. Current Concepts of Pharmacogenetics, Pharmacogenomics, and the “Druggable” Genome
Wolfgang M. Schmidt, Robert M. Mader

13. Pharmacokinetics I: PK-PD Approach, the Case of Antibiotic Drug Development
Sherwin K. B. Sy, Hartmut Derendorf

14. Epidemiology and Biostatistics
Gerhard Garhöfer, Leopold Schmetterer

15. Placebo Effects and Placebo Control in Clinical Trials
Johannes Pleiner-Duxneuner

Part IV. Topics in Clinical Pharmacology

16. Pharmaceutical Drug Safety
Martin Brunner

17. Drug Interactions
Markus Zeitlinger

18. Development of Advanced Therapy Medicinal Products: A Case for Early Scientific Advice
Martin Brunner, Bernd Jilma

19. Biologics
Bernd Jilma, Markus Müller

20. Generics, Biosimilars, Enantiomers, and Me-Toos
Dieter Deforce, George Wade, Brigitte Bloechl-Daum

21. Orphan Drugs for Rare Diseases
Brigitte Bloechl-Daum, Florence Butlen-Ducuing, Jordi Llinares-Garcia

22. Special Situations, Market Fragmentation II: Sex Differences
Ghazaleh Gouya

23. Special Situations III: Medicines for Children
Christoph Male

Keywords: Biomedicine, Pharmacology/Toxicology, Pharmacy, Pharmacotherapy