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Research article

First published 1999-01

Safety Assessment of Biotechnology-Derived Pharmaceuticals: ICH and Beyond

Mercedes A. Serabian, Anne M. Pilaro

Toxicologic Pathology

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Other

First published 2001-1

Preclinical Considerations for Regulatory Submissions

Paul Baldrick

Therapeutic Innovation & Regulatory Science

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Research article

First published 1992-06

Preface,Human Gene Therapy Preclinical Data Document,April 24,1987

Human Gene Therapy

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Review article

First published 2018-10

Best Practice Approach for Assessment of Microchip-associated Tumors in Preclinical Safety Studies: Position of the Registry of Industrial Toxicology Animal-data (RITA)

Stefanie Lapp, Axel Bube, Florian A. Colbatzky [...]

Toxicologic Pathology

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Research article

First published 2018-5

The Early Preclinical Development Program for Locally Administered Investigational Medicinal Products in Ophthalmology

Annick Toggenburger, Rebecca Trönnberg, Alexandra Galland [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 1994-1

Computer-Aided Report Auditing

Alan K. Rawling

Therapeutic Innovation & Regulatory Science

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Research article

First published 2024-03-05

Creating an Unprotected Class: Addressing Legal Risks in the Era of Biologically-Defined Alzheimer’s Disease

Neil Vaishnav, Rosa Gonzalez, Krystal Karunungan [...]

Journal of Alzheimer’s Disease

Free access

Rapid communication

First published 2001-3

Diagnosis of Preclinical and Subclinical Scrapie in a Naturally Infected Sheep Flock Utilizing Currently Available Postmortem Diagnostic Techniques

Amir N. Hamir, Janice M. Miller, Mary Jo Schmerr [...]

Journal of Veterinary Diagnostic Investigation

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Research article

First published 2016-09

Human Umbilical Versus Coronary Cell Sources for Tissue-Engineered Blood Vessel Mimics

Scott Herting, Alex DiBartolomeo, Toni Pipes [...]

Applied In Vitro Toxicology

Open access

Research article

First published 2025-12

C-DILI ™ Assay: A New Mechanism-Based Human In Vitro Screen for Prediction of Cholestatic Liver Toxicity

Jonathan P. Jackson, Kenneth R. Brouwer

Applied In Vitro Toxicology

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