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Open access

Research article

First published 2021-7

Upholding the EU's Commitment to ‘Animal Testing as a Last Resort' Under REACH Requires a Paradigm Shift in How We Assess Chemical Safety to Close the Gap Between Regulatory Testing and Modern Safety Science

Julia Fentem, Ian Malcomber, Gavin Maxwell [...]

Alternatives to Laboratory Animals

Open access

Research article

First published 2022-11

Regulatory Consideration for the Nonclinical Safety Assessment of Gene Therapies

Jeffrey S. Moffit, Diann L. Blanset, Jessica L. Lynch [...]

Human Gene Therapy

Retricted access

Other

First published 2003-12

Regulatory Reform in Light of Regulatory Character: Assessing Industrial Safety Change in the Aftermath of the Kader Toy Factory Fire in Bangkok,Thailand

Fiona Haines

Social & Legal Studies

Retricted access

Research article

First published 2024-06

Regulatory Landscape for Generic Drugs in India: Assessing Quality,Safety,and Efficacy Standards

Azamat Ali, Kunal Sinha

Biotechnology Law Report

Retricted access

Research article

First published 2019

Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions

Greg Ball, Raffael Kurek, Barbara A. Hendrickson [...]

Therapeutic Innovation & Regulatory Science

Free access

Research article

First published 1994-3

Safety Assessment Programs for U.S. Regulatory Agencies: A Perspective of Requirements and Compliance

Raymond A. Bendele

Toxicologic Pathology

Retricted access

Research article

First published 2021-02

Outcomes of the European Federation of Pharmaceutical Industries and Associations Oligonucleotide Working Group Survey on Nonclinical Practices and Regulatory Expectations for Therapeutic Oligonucleotide Safety Assessment

Yann Tessier, William Achanzar, Lauren Mihalcik [...]

Nucleic Acid Therapeutics

Free access

Research article

First published 2020-6

Scientific Regulatory Policy Committee Points to Consider*: Nuisance Factors,Block Effects,and Batch Effects in Nonclinical Safety Assessment Studies

Albert Eric Schultze, Bindu Bennet, Jessica Caverly Rae [...]

Toxicologic Pathology

Free access

Research article

First published 2017-4

Regulatory Forum Opinion Piece * : Use and Utility of Animal Models of Disease for Nonclinical Safety Assessment: A Pharmaceutical Industry Survey

Sherry J. Morgan, Jessica Couch, Peggy Guzzie-Peck [...]

Toxicologic Pathology

Free access

Research article

First published 2014-8

Regulatory Forum Opinion Piece*

Yoichi Konishi, Shim-mo Hayashi, Shoji Fukushima

Toxicologic Pathology

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