Clinical trial considerations on male contraception and collection of pregnancy information from female partner: update-Reference-Cited by-同舟云学术

Clinical trial considerations on male contraception and collection of pregnancy information from female partner: update

Published:2016-07-25 Issue:1 Volume:5 Page:
ISSN:2001-1326
Container-title:Clinical and Translational Medicine
language:en
Short-container-title:Clinical and Translational Medicine

Author:

Banholzer Maria Longauer¹,Wandel Christoph¹,Barrow Paul²,Mannino Marie³,Schmitt Georg²,Guérard Melanie²,Müller Lutz²,Greig Gerard⁴,Amemiya Kenjie⁵,Peck Richard⁴,Singer Thomas²,Doessegger Lucette⁶

Affiliation:

1. Safety Risk ManagementLicensing & Early DevelopmentF. Hoffmann‐La Roche AGBaselSwitzerland

2. Pharma Research & Early DevelopmentRoche Innovation Center BaselPharmaceutical SciencesF. Hoffmann‐La Roche AGBaselSwitzerland

3. Safety Risk ManagementLicensing & Early DevelopmentF. Hoffmann‐La Roche LtdNew YorkNYUSA

4. Pharma Research & Early DevelopmentRoche Innovation Center BaselClinical PharmacologyF. Hoffmann‐La Roche AGBaselSwitzerland

5. Non‐Clinical Safety DepartmentGenentech IncSouth San FranciscoCAUSA

6. ZürichSwitzerland

Publisher

Wiley

Subject

Molecular Medicine,Medicine (miscellaneous)

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1186/s40169-016-0103-8

Reference30 articles.

1. Clinical trial considerations on male contraception and collection of pregnancy information from female partners

2. ICH M7(2014)Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk.http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M7/M7_Step_4.pdf. Accessed 15 Jan 2016

3. Clinical Trial Facilitation Group (CTFG)(2014)Recommendations related to contraception and pregnancy testing in clinical trialshttp://www.hma.eu/fileadmin/dateien/Human_Medicines/01‐About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf. Accessed 15 Jan 2016

4. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)(2015)Assessment of male‐mediated developmental risk for pharmaceuticals guidance for industry: guidance for industry (draft guidance).http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM450627.pdf. Accessed 15 Jan 2016

5. Scientific opinion on genotoxicity testing strategies applicable to food and feed safety assessment;Committee ES;EFSA J,2011

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3. Erratum to: Clinical trial considerations on male contraception and collection of pregnancy information from female partner: update;Clinical and Translational Medicine;2016-08-12