Phase I, two-way, crossover study to demonstrate bioequivalence and to compare safety and tolerability of single-dose XM17 vs Gonal-f® in healthy women after follicle-stimulating hormone downregulation-Reference-Cited by-同舟云学术

Phase I, two-way, crossover study to demonstrate bioequivalence and to compare safety and tolerability of single-dose XM17 vs Gonal-f® in healthy women after follicle-stimulating hormone downregulation

Published:2015-12 Issue:1 Volume:13 Page:
ISSN:1477-7827
Container-title:Reproductive Biology and Endocrinology
language:en
Short-container-title:Reprod Biol Endocrinol

Author:

Lammerich Andreas,Mueller Arnd,Bias Peter

Funder

BioGeneriX AG, now incorporated into Merckle GmbH, a member of the Teva group

Teva Branded Pharmaceutical Products R&D, Inc.

Publisher

Springer Science and Business Media LLC

Subject

Developmental Biology,Endocrinology,Reproductive Medicine,Obstetrics and Gynaecology

Link

http://link.springer.com/content/pdf/10.1186/s12958-015-0124-y

Reference13 articles.

1. Daya S. Follicle-stimulating hormone in clinical practice: an update. Treat Endocrinol. 2004;3:161–71.

2. Dhillon S, Keating GM. Lutropin alfa. Drugs. 2008;68:1529–40.

3. Pouwer AW, Farquhar C, Kremer JAM. Long-acting FSH versus daily FSH for women undergoing assisted reproduction. Cochrane Database Syst Rev. 2012;6:CD009577.

4. European Medicines Agency. Ovaleap (follitropin alfa) [assessment report]. 31 July 2013. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002608/WC500152908.pdf (2013). Accessed 25 Feb 2015.

5. Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Narayanan G, et al. Biosimilars-why terminology matters. Nat Biotechnol. 2011;29:690–3.

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