An update on the animal studies conducted for biosimilar approvals – Regulatory requirement vs actual scenario-Reference-Cited by-同舟云学术

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An update on the animal studies conducted for biosimilar approvals – Regulatory requirement vs actual scenario

Published:2019-10 Issue: Volume:107 Page:104415
ISSN:0273-2300
Container-title:Regulatory Toxicology and Pharmacology
language:en
Short-container-title:Regulatory Toxicology and Pharmacology

Author:

Pipalava Parag,Patel Ronak,Mehta Miten,Dahiya Meghana,Singh Inderjeet,Jose Vinu

Publisher

Elsevier BV

Subject

Toxicology,General Medicine

Reference62 articles.

1. Guideline on Non-clinical and Clinical Development of Similar Biological Medicinal Products Containing Recombinant Erythropoietins (Revision);EMEA/CHMP/BMWP/301636/2008 Corr*,2010

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