Sage Journals: Discover world-class research

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Research article

First published 2019

Shared Learnings on the New EMA First-in-Human and Early Clinical Trial Guideline: Proceedings From a DIAlogue Session at DIA Europe 2018

Jan Willem van der Laan, Charles T. Benson, Walter Janssens [...]

Therapeutic Innovation & Regulatory Science

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Review article

First published 2025-11

Advancing Potency Assay Development for Advanced Therapy Medicinal Products: A Comprehensive Approach and Regulatory Insights

Alaa Abdellatif, Melissa Bou Jaoudeh, Alex Zwiers [...]

Human Gene Therapy

Open access

Review article

First published 2015-07

An Overview of Current Regulatory Requirements for Approval of Biosimilar Insulins

Lutz Heinemann, Hootan Khatami, Ross McKinnon [...]

Diabetes Technology & Therapeutics

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Research article

First published 2026-1

Is there utility in testing IgA-endomysial antibodies in patients with weak-positive or equivocal IgA-tissue transglutaminase antibodies in the diagnosis of coeliac disease? A critique of current NICE guidance (NG20)

Samuel D Brown, Jacqueline Hitchins, Newton ACS Wong [...]

Annals of Clinical Biochemistry: International Journal of Laboratory Medicine

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Research article

First published 2015-1

Clinical Development Approaches and Statistical Methodologies to Prospectively Assess the Cardiovascular Risk of New Antidiabetic Therapies for Type 2 Diabetes

Mary Jane Geiger, Cyrus Mehta, J. Rick Turner [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2023-11

Cross-cultural adaptation and psychometric properties of the engagement in meaningful activities survey

Ellen Cruyt, Mike Jarrey, Ank Eijkelkamp [...]

British Journal of Occupational Therapy

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Research article

First published 2026-3

Liposome drug development as complex pharmaceuticals: Current regulatory aspects in USA and EU

Alishanaz I Subedar, Fazal M. Tai

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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Research article

First published 2019-5

NIRS is having a renaissance;but not all the pieces are moving at the same speed

Emil W Ciurczak

NIR news

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Research article

First published 2018-7

Regional Differences During the ICH Regulatory Consultation Process Between the EU,US,and Japan

Aimad Torqui, Alina Mihaela Macau

Therapeutic Innovation & Regulatory Science

Free access

Review article

First published 2018-10

The surge in biosimilars: considerations for effective pharmacovigilance and EU regulation

Begoña Calvo, Javier Martinez-Gorostiaga, Enrique Echevarria

Therapeutic Advances in Drug Safety

Search results