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Era of surrogate endpoints and accelerated approvals: a comprehensive review on applicability, uncertainties, and challenges from regulatory, payer, and patient perspectives.

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Title: Era of surrogate endpoints and accelerated approvals: a comprehensive review on applicability, uncertainties, and challenges from regulatory, payer, and patient perspectives.
Authors: Sharma R; University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh, 160014, India. rsharma.heor@gmail.com., Gulati A; Centre for Studies in Science Policy, School of Social Sciences, Jawaharlal Nehru University, New Delhi, India., Chopra K; University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh, 160014, India. k.chopra@pu.ac.in.; Pharmacology Research Laboratory, UGC Centre of Advanced Studies, University Institute of Pharmaceutical Sciences (UIPS), Panjab University, Chandigarh, 160014, India. k.chopra@pu.ac.in.
Source: European journal of clinical pharmacology [Eur J Clin Pharmacol] 2025 May; Vol. 81 (5), pp. 605-623. Date of Electronic Publication: 2025 Mar 13.
Publication Type: Journal Article; Review
Journal Info: Publisher: Springer Country of Publication: Germany NLM ID: 1256165 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1432-1041 (Electronic) Linking ISSN: 00316970 NLM ISO Abbreviation: Eur J Clin Pharmacol Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: <searchLink fieldCode="AU" term="%22Sharma+R%22">Sharma R</searchLink>; University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh, 160014, India. rsharma.heor@gmail.com.<br /><searchLink fieldCode="AU" term="%22Gulati+A%22">Gulati A</searchLink>; Centre for Studies in Science Policy, School of Social Sciences, Jawaharlal Nehru University, New Delhi, India.<br /><searchLink fieldCode="AU" term="%22Chopra+K%22">Chopra K</searchLink>; University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh, 160014, India. k.chopra@pu.ac.in.; Pharmacology Research Laboratory, UGC Centre of Advanced Studies, University Institute of Pharmaceutical Sciences (UIPS), Panjab University, Chandigarh, 160014, India. k.chopra@pu.ac.in.
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