Sage Journals: Discover world-class research

Free access

Research article

First published 1999-01

Regulatory Decision Strategy for Entry of a Novel Biologic Therapeutic with a Clinically Unmonitorable Toxicity into Clinical Trials: Pre-IND Meetings and a Case Example

Lauren E. Black, Alison M. Bendele, Ray A. Bendele [...]

Toxicologic Pathology

Free access

Other

First published 1996-05

Regulatory Issues of Importance to Developing Anti-HIV Therapeutics

Kenneth L. Hastings

Toxicologic Pathology

Retricted access

Research article

First published 2014-11

Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND

Sundeep S. Sethi, Judith M. Kramer, Suzanne Gagnon [...]

Therapeutic Innovation & Regulatory Science

Retricted access

Research article

First published 1994-12

Regulatory Considerations for Oligonucleotide Drugs: Updated Recommendations for Pharmacology and Toxicology Studies

Lauren E. Black, James G. Farrelly, Joy A. Cavagnaro [...]

Nucleic Acid Therapeutics

Free access

Research article

First published 2015-1

Preclinical Study Design for Evaluation of Stem Cell–derived Cellular Therapy Products

Julia F. M. Baker, Basel T. Assaf

Toxicologic Pathology

Retricted access

Research article

First published 1997-7

Initiatives to Speed New Drug Development and Regulatory Review: The Impact of FDA-Sponsor Conferences

Joseph A. DiMasi, Michael Manocchia

Therapeutic Innovation & Regulatory Science

Retricted access

Research article

First published 1995-10

Can Regulatory Affairs Personnel Add Value When the Goal is Increasing Speed of Drug Development?

David M. Cocchetto

Therapeutic Innovation & Regulatory Science

Retricted access

Research article

First published 1988-10

More Similarities than Differences

Marion J. Finkel

Therapeutic Innovation & Regulatory Science

Retricted access

Research article

First published 2020

Efficient Computation of the Large Inductive Dimension Using Order- and Graph-theoretic Means

Rudolf Berghammer, Henning Schnoor, Michael Winter

Fundamenta Informaticae

Free access

Review article

First published 2001-04

The selection of marmoset monkeys (Callithrix jacchus) in pharmaceutical toxicology

Laboratory Animals

Search results