Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined.

As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume "Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: "Methods in Clinical Pharmacology".

<p>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.</p>