Practical Issues of Preclinical Pharmacokinetic Investigations of New Drugs (Review)

Practical Issues of Preclinical Pharmacokinetic Investigations of New Drugs (Review)

Several issues with pharmacokinetic studies of new drugs, in particular, experiment planning, development of study protocols, dose selection, and administration routes, are reviewed. The number of used animals is justified statistically with respect to bioethics. The pharmacokinetic study protocol i...

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Veröffentlicht in:Pharmaceutical chemistry journal 2019-07, Vol.53 (4), p.281-287
Hauptverfasser: Chistyakov, V. V., Stepanova, E. S.
Format: Artikel
Sprache:eng
Schlagworte:
Bioethics
Drugs
Investigations
Medicine
Molecular-Biological Problems of Drug Design and Mechanism of Drug Action
Organic Chemistry
Pharmacology/Toxicology
Pharmacy
Regulatory compliance
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Zusammenfassung:Several issues with pharmacokinetic studies of new drugs, in particular, experiment planning, development of study protocols, dose selection, and administration routes, are reviewed. The number of used animals is justified statistically with respect to bioethics. The pharmacokinetic study protocol is discussed in more detail according to domestic regulatory requirements. Modern approaches to combining bioanalytical methods with pharmacokinetic studies are described.
ISSN:0091-150X
1573-9031
DOI:10.1007/s11094-019-01995-0