Literature DB >> 23299647

Gender differences in drug bioequivalence: time to rethink practices.

G Koren1, H Nordeng, S MacLeod.   

Abstract

Currently, bioequivalence (BE) studies are carried out exclusively in males, assuming that intrasubject variabilities are similar between the sexes. This article challenges this hypothesis on the basis of available evidence and urges that studies of BE of sufficient power be undertaken in women also for all generic drugs aimed at women.

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Year:  2012        PMID： 23299647     DOI： 10.1038/clpt.2012.233

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN： 0009-9236            Impact factor:   6.875


  9 in total

1.  Sex as a variable in medicines assessment reports for licensing in the European Union. Can gender bias be excluded?

Authors:  N Laguna-Goya; F de Andres-Trelles
Journal:  Eur J Clin Pharmacol       Date:  2014-02-11       Impact factor: 2.953

Review 2.  Physiologically-based pharmacokinetic models: approaches for enabling personalized medicine.

Authors:  Clara Hartmanshenn; Megerle Scherholz; Ioannis P Androulakis
Journal:  J Pharmacokinet Pharmacodyn       Date:  2016-09-19       Impact factor: 2.745

3.  Evaluation of sex-by-formulation interaction in bioequivalence studies of efavirenz tablets.

Authors:  Esperanza González-Rojano; Francisco Abad-Santos; Dolores Ochoa; Manuel Román; Julio Marcotegui; Covadonga Álvarez; John Gordon; Alfredo García-Arieta
Journal:  Br J Clin Pharmacol       Date:  2018-05-22       Impact factor: 4.335

4.  Gender differences in the adverse events associated with cardiovascular drugs in a spontaneous reporting system in South Korea.

Authors:  Han-Heui Park; Ju Hwan Kim; Dongwon Yoon; Hyesung Lee; Ju-Young Shin
Journal:  Int J Clin Pharm       Date:  2021-01-13

Review 5.  Sex-by-formulation interaction in bioequivalence trials with transdermal patches.

Authors:  Esperanza González-Rojano; Julio Marcotegui; Susana Morales-Alcelay; Covadonga Álvarez; John Gordon; Francisco Abad-Santos; Alfredo García-Arieta
Journal:  Eur J Clin Pharmacol       Date:  2019-02-06       Impact factor: 2.953

Review 6.  Microphysiological modeling of the reproductive tract: a fertile endeavor.

Authors:  Sharon L Eddie; J Julie Kim; Teresa K Woodruff; Joanna E Burdette
Journal:  Exp Biol Med (Maywood)       Date:  2014-04-15

Review 7.  Sex-Gender Variable: Methodological Recommendations for Increasing Scientific Value of Clinical Studies.

Authors:  Flavia Franconi; Ilaria Campesi; Delia Colombo; Paola Antonini
Journal:  Cells       Date:  2019-05-17       Impact factor: 6.600

8.  Characterization of the Pharmacokinetics of Samidorphan in Healthy Volunteers: Absolute Bioavailability and the Effect of Food and Age.

Authors:  Vipul Kumar; Hong Lu; Marjie Hard; Lisa von Moltke
Journal:  Drugs R D       Date:  2019-09

9.  Gender differences in the adverse events' profile registered in seven observational studies of a wide gender-medicine (MetaGeM) project: the MetaGeM safety analysis.

Authors:  Delia Colombo; Emanuela Zagni; Mihaela Nica; Sara Rizzoli; Alessandra Ori; Gilberto Bellia
Journal:  Drug Des Devel Ther       Date:  2016-09-13       Impact factor: 4.162
  9 in total

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