創薬と薬物評価：臨床薬理学実験法 Drug Discovery and Evaluation : Methods in Clinical Pharmacology

Vogel, Hans Georg (EDT)/ Maas, Jochen (EDT)/ Gebauer, Alexander (EDT)

Springer（2010/12発売）

• 製本 Hardcover:ハードカバー版／ページ数 564 p.／サイズ 138 illus.
• 商品コード 9783540898900

基本説明

An easy-to-use, method-oriented overview on all aspects of clinical pharmacology.

Full Description

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. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects.

Contents

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.