Regulatory Science of Medical Products
Online ISSN : 2189-0447
Print ISSN : 2185-7113
ISSN-L : 2185-7113
Concepts of Need for Male Contraception Related to Drug Administration
Hiromitsu NEGOROHiroyuki NISHIYAMA
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JOURNAL FREE ACCESS

2022 Volume 12 Issue 1 Pages 55-62

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Abstract

Guidance on the need for contraception related to use of pharmaceuticals has been shaped by the Japan agency for medical research and development (AMED) research group, providing information on the proper use of pharmaceuticals in patients with reproductive potential. The guidance provides basic concepts regarding the conditions under which contraception is recommended during or after the last dose of medication and the duration of contraception, in order to minimize the potential risk for embryonic and fetal development from the use of medications in patients of reproductive potential. This article outlines the guidance on male contraception and adds three additional points: “assisted reproductive technology (e. g., sperm cryopreservation)”, “risk of reproductive and developmental toxicity by radiopharmaceuticals, regenerative medicine products, vaccines, etc.”, and “risk of infection to partners from sexual activity with pharmaceuticals that may be infectious.

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© 2022 Society for Regulatory Science of Medical Products
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