A Randomized Phase I Study Comparing the Pharmacokinetics of HD201, a Trastuzumab Biosimilar, With European Union–sourced Herceptin-Reference-Cited by-同舟云学术

A Randomized Phase I Study Comparing the Pharmacokinetics of HD201, a Trastuzumab Biosimilar, With European Union–sourced Herceptin

Published:2018-03 Issue:3 Volume:40 Page:396-405.e4
ISSN:0149-2918
Container-title:Clinical Therapeutics
language:en
Short-container-title:Clinical Therapeutics

Author:

Pivot Xavier,Deslypere Jean Paul,Park Lisa Soyeon,Kim Michael Jinwoo,Lee Wonjae,Lee Jeonghyeon

Publisher

Elsevier BV

Subject

Pharmacology (medical),Pharmacology

Reference22 articles.

1. Trastuzumab in the treatment of breast cancer;Hortobagyi;N Engl J Med,2005

2. Limited RR. Herceptin® (trastuzumab) summary of product characteristics. http://wwwemaeuropaeu/%20docs/en_GB/document_library/EPAR_-_Product_Information/%20human/000278/WC500074922pdf. 2016.

3. Agencies UEM. Scientific considerations in demonstrating biosimilarity to a reference product, Guidance for Industry. http://wwwfdagov/downloads/drugs/guidanceComplianceRegulatoryInformation/Guidances/UCM291128pdf. 2015.

4. Agency EM. Guideline on similar biological products containing biotechnology-derived proteins as active sustance: non-clinical and clinical issues. http://wwwemaeuropaeu/docs/en_GB/document_library/Scientif_guideline/2015/01/WC500180219pdf. 2015.

5. European Medecines Agency cfMpfHU. Guideline on similar biological medecinal products containing monoclonal antibodies—non clinical and clinical issues. http://wwwemaeuropaeu/docs/en_GB/document_library/Scientif_guideline/2012/06/WC500128686pdf. 2012.

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