Drug Discovery and Evaluation: Methods in Clinical Pharmacology

H. Gerhard Vogel is a licenced Pharmacist and Physician (Universities of Erlangen and T?bingen, Germany). He taught as Professor of Pharmacology and Toxicology at the Universities Marburg and Frankfurt. He joined Research at the pharmaceutical company Hoechst AG, Frankfurt, to become Head of Endocrinology, Head of the Department of Pharmacology, and the Head of International Preclinical Evaluation and Development. His latest position was Head of the Decision Board on Pharmaceutical Development. At present, he is working as a Consultant for Pharmaceutical and Medical Research and Development. His scientific work was devoted to the elaboration of new pharmacological methods, pharmacology of plant extracts from various countries, pharmacology of steroid hormones, pharmacology of peptide hormones, pharmacology of cardiac glycosides, biomechanics and biochemistry of connective tissue, experimental gerontology, experimental dermatology, and development procedures for pharmaceutical products. H. Gerhard Vogel has published more than 160 papers, mainly on new pharmacological methods, on endocrinology (in particular peptide endocrinology), biomechanics and biochemistry of connective tissue, such as skin and bone, and on other topics. He is a member of many international and national scientific societies and a co-editor and contributor to several scientific textbooks. Together with Wolfgang H. Vogel he published the first edition of Drug Discovery and Evaluation: Pharmacological Assays (Springer-Verlag Berlin Heidelberg New York) in 1997. The second completely revised, updated and enlarged edition with many contributions by his colleagues was published in 2002. The third edition of that work was published in late 2007. He is also Editor-in-Chief of the book Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays, which was published at Springer as well.Jochen Maas is a biologist and DVM from background (Universities of Heidelberg, Munich and Zurich, Germany and Switzerland). He joined Research at the pharmaceutical company Hoechst AG, Frankfurt, as laboratory head in the area of animal pharmacokinetics. Via a position as section head he became head of the Drug Metabolism and Pharmacokinetics Department in Frankfurt, followed by an identical responsibility in Paris and Europe for the company Aventis. Simultaneously he was responsible for the whole Development area in Germany. His latest positions were Vice President for Research and Development Europe , member of the European Strategic Management Committee and global deputy head of the Metabolism and Pharmacokinetic department of Sanofi Aventis. Simultaneously, he gives lectures in Pharmacokinetics and Drug Delivery Devices at the University of applied science, Giessen-Friedberg.His scientific work was devoted to the elaboration of new pharmacokinetic models and methods both in the discovery, preclinical and clinical area. He wrote some chapters of the first edition of Drug Discovery and Evaluation: Pharmacological Assays (Springer-Verlag Berlin Heidelberg New York) in 1997. The second completely revised, updated and enlarged edition with many contributions by his colleagues was published in 2002. The third edition of that work was published in late 2007. He is also Co-editor of the book Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays, which was published at Springer as well.Alexander Gebauer, MD, PhD, studied medicine at the Medical Faculty of the University Mainz, Germany until 1988 and additionally earned a degree in Computer Science at the CBI, Wiesbaden, Germany. After several years as scientist in the department of Neuropharmacology, University of Mainz, where he completed his thesis on opioid receptors, he joined the pharmaceutical industry. From 1992 on he held different positions at Aventis (finally head of early development in Frankfurt) and predecessor companies. After the Sanofi-Aventis merger, he was responsible for all cardiovascular development projects at the newly formed company. In 2005 he joined Merz Pharmaceuticals GmbH in Frankfurt, Germany, where he is a member of the managing board and Chief Scientific Officer.

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.