Drug discovery and evaluation : methods in clinical pharmacology

A. Clinical Pharmacokinetics.- Single Dose studies incl. Dose finding by allometry.- Multiple Dose studies.- Dose linearity and Proportionality.- Special Populations.- The hADME-study (incl. Dosimetry) and its results.- Synthesis of radiolabelled compounds for clinical studies.- Regulatory Guidelines regarding Metabolite identification and testing.- Drug-Drug interaction studies.- In vitro in vivo correlation for drug-drug interactions.- Specific studies for formulation development.- Absolute and relative bioavailability.- Bioequivalence.- PopKin approaches.- Bioanalysis of clinical studies.- Biomarker, surrogate parameters and clinical endpoints. -Toxicokinetics and safety ratios.- Relevance of transporters in clinical studies.- In vitro in vivo correlation for transporters.- Specifities of oncology studies.- Pharmacogenomics and its influence on Pharmacokinetics.- PK/PD approaches B. Human Studies in Clinical Pharmacology: Methodologies of PD assessment - Scales.- Methodologies of PD assessment - BioStat. -Methodologies of Safety assessment.- Pharmacodynamic Evaluation.- Respiratory System.- Pharmacodynamic Evaluation.- Cardiovascular Methodologies.- Pharmacodynamic Evaluation.- CNS.- Pharmacodynamic Evaluation.- Diabetes Methodologies.- Pharmacodynamic Evaluation.- Metabolism/Lipids.- Pharmacodynamic Evaluation.- Inflammation/Immunology.- Pharmacodynamic Evaluation.- Pain.- Pharmacodynamic Evaluation.- Endocrinology.- Pharmacodynamic Evaluation.- Anesthetics.- Pharmacodynamic Evaluation.- Dermatology.- Pharmacodynamic Evaluation.- Oncology.- Pharmacodynamic Evaluation.- Antibiotics.- Pharmacodynamic DD interaction.- Pharmacogenomics: Pharmacodymanic relevance C. Regulations: Regulatory requirements in Clinical Pharmacology.