Overview of non-innovator biological products in India

As per regulatory requirements, biosimilar drugs must show high similarity to their reference product in quality, preclinical and clinical tests. It is by these means that biosimilars are considered to be safe and efficacious. In India, any major deviation(s) from science-based principles in the man...

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Bibliographische Detailangaben

Veröffentlicht in:	GaBI Journal 2020-03, Vol.9 (1), p.30-36
1. Verfasser:	Soni, G.R
Format:	Artikel
Sprache:	eng
Schlagworte:	Biological products Comparative analysis Health aspects Product introduction Regulatory compliance
Online-Zugang:	Volltext
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