INFLUENCE OF SEX DIFFERENCES ON PHARMACOKINETICS OF DRUGS WITHIN THE FRAMEWORK OF BIOEQUIVALENCE STUDIES OF GENERIC MEDICINAL PRODUCTS

Background. Evidence of the effect of sex on the pharmacokinetics of drugs and, accordingly, on the clinical response is significantly accumulated, because of a growing number of clinical studies of the early development of original drugs, which include female subjects. The number of bioequivalence...

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Autores principales:	D. P. Romodanovsky, D. V. Goryachev, A. L. Khokhlov, A. E. Miroshnikov
Formato:	article
Lenguaje:	RU
Publicado:	Scientific Сentre for Family Health and Human Reproduction Problems 2018
Materias:	bioequivalence pharmacokinetics sex differences reproduced drugs intra-individual variability Science Q
Acceso en línea:	https://doaj.org/article/713248eeafce4665b7609405fe548eea
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spelling	oai:doaj.org-article:713248eeafce4665b7609405fe548eea2021-11-23T06:14:41ZINFLUENCE OF SEX DIFFERENCES ON PHARMACOKINETICS OF DRUGS WITHIN THE FRAMEWORK OF BIOEQUIVALENCE STUDIES OF GENERIC MEDICINAL PRODUCTS2541-94202587-959610.29413/ABS.2018-3.5.15https://doaj.org/article/713248eeafce4665b7609405fe548eea2018-09-01T00:00:00Zhttps://www.actabiomedica.ru/jour/article/view/714https://doaj.org/toc/2541-9420https://doaj.org/toc/2587-9596Background. Evidence of the effect of sex on the pharmacokinetics of drugs and, accordingly, on the clinical response is significantly accumulated, because of a growing number of clinical studies of the early development of original drugs, which include female subjects. The number of bioequivalence studies of replicated drugs involving both sexes is also growing. Of particular importance for the bioavailability of oral medications are differences in the anatomy and physiology of the digestive system. Along with this factor, the differences may be due to the dosage form of the reproduced drug, which may differ from that of the reference (original). The aim of the study was to identify the effect of sex differences on the pharmacokinetics of drugs and to propose an algorithm for assessing their detection. Materials and methods. The article presents a general analysis of the works devoted to the pharmacokinetics of medicines in men and women and includes literature data. Results. The main factors influencing the pharmacokinetics of drugs (absorption, distribution, metabolism, excretion) are identified. Examples of medicinal products for which differences in pharmacokinetics in men and women are revealed are given. The article describes the main international requirements for conducting clinical trials and bioequivalence studies with regard to the choice of gender of subjects and their number to be included in the clinical study. It is suggested that there is a need to further study of the effect of sex differences on bioequivalence results in carrying out relevant studies. Conclusion. An algorithm for estimating the detection of sex differences and their effect on the results of bioequivalence studies of generic drugs is proposed.D. P. RomodanovskyD. V. GoryachevA. L. KhokhlovA. E. MiroshnikovScientific Сentre for Family Health and Human Reproduction Problemsarticlebioequivalencepharmacokineticssex differencesreproduced drugsintra-individual variabilityScienceQRUActa Biomedica Scientifica, Vol 3, Iss 5, Pp 94-105 (2018)
institution	DOAJ
collection	DOAJ
language	RU
topic	bioequivalence pharmacokinetics sex differences reproduced drugs intra-individual variability Science Q
spellingShingle	bioequivalence pharmacokinetics sex differences reproduced drugs intra-individual variability Science Q D. P. Romodanovsky D. V. Goryachev A. L. Khokhlov A. E. Miroshnikov INFLUENCE OF SEX DIFFERENCES ON PHARMACOKINETICS OF DRUGS WITHIN THE FRAMEWORK OF BIOEQUIVALENCE STUDIES OF GENERIC MEDICINAL PRODUCTS
description	Background. Evidence of the effect of sex on the pharmacokinetics of drugs and, accordingly, on the clinical response is significantly accumulated, because of a growing number of clinical studies of the early development of original drugs, which include female subjects. The number of bioequivalence studies of replicated drugs involving both sexes is also growing. Of particular importance for the bioavailability of oral medications are differences in the anatomy and physiology of the digestive system. Along with this factor, the differences may be due to the dosage form of the reproduced drug, which may differ from that of the reference (original). The aim of the study was to identify the effect of sex differences on the pharmacokinetics of drugs and to propose an algorithm for assessing their detection. Materials and methods. The article presents a general analysis of the works devoted to the pharmacokinetics of medicines in men and women and includes literature data. Results. The main factors influencing the pharmacokinetics of drugs (absorption, distribution, metabolism, excretion) are identified. Examples of medicinal products for which differences in pharmacokinetics in men and women are revealed are given. The article describes the main international requirements for conducting clinical trials and bioequivalence studies with regard to the choice of gender of subjects and their number to be included in the clinical study. It is suggested that there is a need to further study of the effect of sex differences on bioequivalence results in carrying out relevant studies. Conclusion. An algorithm for estimating the detection of sex differences and their effect on the results of bioequivalence studies of generic drugs is proposed.
format	article
author	D. P. Romodanovsky D. V. Goryachev A. L. Khokhlov A. E. Miroshnikov
author_facet	D. P. Romodanovsky D. V. Goryachev A. L. Khokhlov A. E. Miroshnikov
author_sort	D. P. Romodanovsky
title	INFLUENCE OF SEX DIFFERENCES ON PHARMACOKINETICS OF DRUGS WITHIN THE FRAMEWORK OF BIOEQUIVALENCE STUDIES OF GENERIC MEDICINAL PRODUCTS
title_short	INFLUENCE OF SEX DIFFERENCES ON PHARMACOKINETICS OF DRUGS WITHIN THE FRAMEWORK OF BIOEQUIVALENCE STUDIES OF GENERIC MEDICINAL PRODUCTS
title_full	INFLUENCE OF SEX DIFFERENCES ON PHARMACOKINETICS OF DRUGS WITHIN THE FRAMEWORK OF BIOEQUIVALENCE STUDIES OF GENERIC MEDICINAL PRODUCTS
title_fullStr	INFLUENCE OF SEX DIFFERENCES ON PHARMACOKINETICS OF DRUGS WITHIN THE FRAMEWORK OF BIOEQUIVALENCE STUDIES OF GENERIC MEDICINAL PRODUCTS
title_full_unstemmed	INFLUENCE OF SEX DIFFERENCES ON PHARMACOKINETICS OF DRUGS WITHIN THE FRAMEWORK OF BIOEQUIVALENCE STUDIES OF GENERIC MEDICINAL PRODUCTS
title_sort	influence of sex differences on pharmacokinetics of drugs within the framework of bioequivalence studies of generic medicinal products
publisher	Scientific Сentre for Family Health and Human Reproduction Problems
publishDate	2018
url	https://doaj.org/article/713248eeafce4665b7609405fe548eea
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INFLUENCE OF SEX DIFFERENCES ON PHARMACOKINETICS OF DRUGS WITHIN THE FRAMEWORK OF BIOEQUIVALENCE STUDIES OF GENERIC MEDICINAL PRODUCTS

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