Titlebook: Integration of Pharmacokinetics, Pharmacodynamics, and Toxicokinetics in Rational Drug Development; Avraham Yacobi (Director),Jerome P. Sk

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并排上下

The Case for Preclinical Pharmacodynamicst of relevant variables such as pharmacologically active metabolites, pharmacodynamic drug interactions and effects of genetics and underlying diseases. Available (though limited) information indicates that drug concentrations required to produce a defined intensity of pharmacologic action are quite

易怒

Grievance

Pharmacokinetics and Drug Metabolism in Animal Studies (ADME, Protein Binding, Mass Balance, Animal at drug, and should be initiated very early in the drug development program. These studies are of primary importance for the planning and design of animal toxicity studies, and for the selection of the appropriate animal model for purposes of estimating a safe clinical dose. Examples of the usefulne

伪书

Nonclinical Considerations: Disposition of Drugs data. Recommendations will be offered regarding the conduct of studies relating the advantages of using the same species, route of administration, and frequency of administration, where possible, as that proposed for pharmacologic and toxicologic testing. The period of dosing should be representati

外形

浸软

Use of Pharmacokinetics and Pharmacodynamics in Preclinical Studies to Guide Dosage Escalation Scheminical testing and Phase I clinical trials. Recent experiences with very lengthy Phase I trials for at least 8 drugs have provided particular impetus for the project. The specific concept was that dose-limiting toxicity is predicted by drug concentrations in plasma, and that the quantitative relatio

旧石器时代

Use of Toxicokinetic Principles in Drug Development: Bridging Preclinical and Clinical Studiessuring blood levels, the concept of comparing safe/toxic blood concentrations in animals to those in man has not been fully realized. Furthermore, in many cases, the frequency of dosing in animal safety studies may not match with that proposed for use in man. Many examples exist demonstrating that t

挑剔为人

Preclinical Pharmacodynamics of Central Nervous System Active Agentsarmacological properties of new psychotropic drugs. In this chapter a new approach is proposed for this type of investigations, which allows additional quantitative pharmacodynamic information (i.e. potency, intrinsic efficacy, rate of biophase equilibration) to be derived.

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