Drug Discovery and Evaluation: Methods in Clinical Pharmacology

Section A Introduction: 1 General Introduction; - Section B Human Studies in Clinical Pharmacology: 2 Methodologies of Safety Assessment in Clinical Pharmacology; - 3 Pharmacodynamic Evaluation: Cardiovascular Methodologies;- 4 Pharmacodynamic Evaluation: Pulmonary Methodologies;- 5 Pharmacodynamic Evaluation: CNS Methodologies;- 6 Pharmacodynamic Evaluation: Pain Methodologies; - 7 Pharmacodynamic Evaluation: Drug Dependency and Addiction;- 8 Pharmacodynamic Evaluation: Ocular Pharmacology; - 9 Pharmacodynamic Evaluation: Acoustic Pharmacology (Tinnitus); - 10 Pharmacodynamic Evaluation: Diabetic Methodologies;- 11 Pharmacodynamic Evaluation: Gastroenterology; - 12 Pharmacodynamic Evaluation: Endocrinology;- 13 Pharmacodynamic Evaluation: Inflammation/Immunology; - 14 Pharmacodynamic Evaluation: Dermatology;- 15 Pharmacodynamic Evaluation: Infectious Diseases;- 16 Pharmacodynamic Evaluation: Oncology;- 17 Pharmacodynamic Evaluation: Gentherapy;- 18 Pharmacodynamic Evaluation: Orphan Diseases; - 19 Clinical Studies in Infants (Pediatric Pharmacology); - 20 Clinical Studies in Geriatric Population; - 21 Personalized Medicine;- 22 Non-invasive Methodology (NMR);- 23 Traditional Chinese Medicine; - 24 Pharmacodynamic Evaluation: Herbal Medicine;- 25 Nanotechnology in Medicine;- 26 Methodologies of PD Assessment Scales;- 27 Methodologies of Pharmacodynamic Assessment;- 28 Pharmacodynamic Drug-Drug Interaction. Section C Clinical Pharmacokinetics: 29 Dose Finding in Single Dose Studies by Allometric Scaling;- 30 Multiple Dose Studies;- 31 Dose Linearity and Proportionality;- 32 Effects of Food Intake;- 33 Special Populations: Profiling the Effect of Obesity on Drug Disposition;- 34 Special Population: Renal Impairment;- 35 Special Population: Hepatic Impairment; - 36 Special Population: Protein Binding Aspects;- 37 The Human ADME Study;- 38 Synthesis of Radiolabeled Compounds for Clinical Studies;- 39 Drug-Drug Interaction Studies;- 40 In Vitro/In Vivo Correlation for Drug-Drug Interaction;- 41 Specific Studies for Formulation Development;- 42 Absolute and Relative Bioavailability;- 43 Bioequivalence; - 44 Population Pharmacokinetics in Clinical Pharmacology;- 45 Bioanalysis of Clinical Studies;- 46 Biomarker Definition and Validation During Drug Development;- 47 Toxicokinetics and Safety Ratios;- 48 In Vitro/In Vivo Correlation for Transporters;- 49 Relevance of Transporters in Clinical Studies; 50 Specificities for Oncology Studies;- 51 Pharmacogenomics in and its Influence on Pharmacokinetics;- 52 PK/PD Approaches. Section D Regulations: 53 Regulatory Guidance: EMA, FDA, ICH;- 54 Development of Regulations for Submitting Pharmacogenomic Data to Authorities; - 55 Pharmacogenomic-Guided Drug Development;- 56 Clinical Quality Management System

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• Bioquímica
• Farmacologia

Assays;drug action;drugs;clinical pharmacology;pharmacodynamics;pharmacokinetics;pharmacotherapy