publication . Article . 2020

Dose Selection in Preclinical Studies: Cross-Species Dose Conversion

E. V. Shekunova; M. A. Kovaleva; M. N. Makarova; V. G. Makarov;
Open Access Russian
  • Published: 01 Feb 2020 Journal: Ведомости Научного центра экспертизы средств медицинского применения, volume 10, issue 1, pages 19-28 (issn: 1991-2919, eissn: 2619-1172, Copyright policy)
  • Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”
Abstract
<jats:p>One of the major obstacles to effective translational medicine is the challenge of translating animal research results into clinical studies. Scientific literature mainly addresses the selection of the drug dose at initiation of clinical trials (Phase 1). Appropriate selection of doses is also essential for preclinical toxicology and pharmacology studies. Some basic principles that are used when translating dosages from animal models to humans are applicable to selection and justification of doses when planning and conducting preclinical studies. The paper provides an overview of the main methods that can be used for selection and justification of animal...
Persistent Identifiers
Subjects
free text keywords: preclinical studies, dose selection, cross-species dose translation, equivalent doses, allometric approach, compartmen-tal model, lcsh:Medicine (General), lcsh:R5-920, Preclinical toxicology, Medicine, business.industry, business, Dose conversion, Body weight, Clinical trial, Dose, Medical physics, medicine.medical_specialty, Pharmacodynamics, Translational medicine, Pharmacokinetics
Any information missing or wrong?Report an Issue