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Research article

First published 1997-7

An Index of United States Federal Regulations and Guidelines Which Cover Clinical Safety Surveillance of Biological Products

Charles F. Curran, Judith M. Sills

Therapeutic Innovation & Regulatory Science

Free access

Research article

First published 1997-01

Problems Associated with the Absence of Activity in Standard Models of Safety Pharmacology used to Assess Biologic Products

Martin D. Green

International Journal of Toxicology

Free access

Research article

First published 2025-1

Applications of Cell-Based Protein Array Technology to Preclinical Safety Assessment of Biological Products

Axel Vicart, Cam Holland, Kathryn Fraser [...]

Toxicologic Pathology

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Research article

First published 2016-2

Environmental contamination by cyclophosphamide preparation: Comparison of conventional manual production in biological safety cabinet and robot-assisted production by APOTECAchemo

Rudolf Schierl, Carla Masini, Svenja Groeneveld [...]

Journal of Oncology Pharmacy Practice

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Research article

First published 2009-2

Biologicals in Japan

Rokuro Hama

International Journal of Risk & Safety in Medicine

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Research article

First published 2011-7

Evergreening biologics

D Christopher Ohly, Sailesh K Patel

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

Open access

Research article

First published 2022-11

Safety of belimumab in adult patients with systemic lupus erythematosus: Results of a large integrated analysis of controlled clinical trial data

Daniel J Wallace, Tatsuya Atsumi, Mark Daniels [...]

Lupus

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Research article

First published 2011-1

Similar biological medicinal products: lessons learned and challenges ahead

Sol Ruiz, Gonzalo Calvo

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

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Research article

First published 2009-2

Quality and safety considerations for recombinant biological medicines: A regulatory perspective

Henry J. Barnes, Gert Ragnarsson, Gunnar Alván

International Journal of Risk & Safety in Medicine

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Research article

First published 1991-4

On Establishing the Safety of Cosmetic Ingredients and Products Produced and/or Marketed within the European Economic Community

Michael Balls

Alternatives to Laboratory Animals

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