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Chapter-13 Regulations for the Development and Clinical Trials of Biosimilars

BOOK TITLE: Drug Discovery and Clinical Research

Author
1. Prakash Jai
2. Bhatia Amandeep
ISBN
9789352705771
DOI
10.5005/jp/books/18166_14
Edition
2/e
Publishing Year
2019
Pages
16
Author Affiliations
1. Central Indian Pharmacopoeia Laboratory (CIPL), Raj Nagar, Ghaziabad (UP) (India), Institute of Medical Sciences, Banaras Hindu University, Varanasi (UP), Institute of Medical Sciences, Banaras Hindu University, Varanasi, India, Meera Bai Polytechnic, Maharani Bagh, New Delhi-110065, India, Indian Pharmacopoeia Commission (IPC), Ministry of Health and Family Welfare, GOI, Raj Nagar, Ghaziabad (UP), India, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghaziabad, Uttar Pradesh, India
2. Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghaziabad, Uttar Pradesh, India
Chapter keywords
Regulation, clinical trial, biosimilar, biotherapeutics, biotech drug, biomedicine, generic medicine, clinical development, European Union regulation, European medicines agency, EMA, interchangeable product

Abstract

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