Prior, Helen; Baldrick, Paul; Beken, Sonja; Booler, Helen; Bower, Nancy; Brooker, Paul; Brown, Paul; Burlinson, Brian; Burns-Naas, Leigh Ann; Casey, Warren; Chapman, Melissa; Clarke, David; de Haan, Lolke; Doehr, Olaf; Downes, Noel; Flaherty, Meghan; Gellatly, Nichola; Moesgaard, Sophia Gry; Harris, Jennifer; Holbrook, Mark; Hui, Julia; Jones, David; Jones, Keith; Kedar, Hilla; Mahl, Andreas; Manninen, Alli; McGuire, Aidan; Mortimer-Cassen, Elisabeth; Peraza, Marjorie; Pugsley, Michael K.; Richard, Jacques; Roberts, Ruth; Roosen, Wendy; Rothfuss, Andreas; Schoenmakers, Ankie; Sewell, Fiona; Weaver, Richard; Weir, Lucinda; Wolfreys, Alison; Kimber, Ian

Use of Big Data to Evaluate Responses to Changes in Regulatory Guidelines: Trends in Genotoxicity Testing Packages for New Pharmaceutical Products

THERAPEUTIC INNOVATION & REGULATORY SCIENCE

IF1.9

2019-12-061

PREAI

Safety Evaluation of PQ Birch Allergy Immunotherapy to Support Product Development

REGULATORY TOXICOLOGY AND PHARMACOLOGY

IF3.5

2019-11-010

PREAI

Pharmacokinetic and toxicology comparator testing of biosimilar drugs - Assessing need

REGULATORY TOXICOLOGY AND PHARMACOLOGY

IF3.5

2017-06-017

PREAI

Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges

MABS

IF7.3

2016-02-0629

OAAI

Preclinical development of monoclonal antibodies Considerations for the use of non-human primates

MABS

IF7.3

2014-10-2768

Recommendations from a global cross-company data sharing initiative on the incorporation of recovery phase animals in safety assessment studies to support first-in-human clinical trials

REGULATORY TOXICOLOGY AND PHARMACOLOGY

IF3.5

2014-10-0122

OAAI

Sewell, Fiona; Chapman, Kathryn; Baldrick, Paul; Brewster, David; Broadmeadow, Alan; Brown, Paul; Burns-Naas, Leigh Ann; Clarke, Janet; Constan, Alex; Couch, Jessica; Czupalla, Oliver; Danks, Andy; DeGeorge, Joseph; de Haanm, Lolke; Hettinger, Klaudia; Hill, Marilyn; Festag, Matthias; Jacobs, Abby; Jacobson-Kram, David; Kopytek, Stephan; Lorenz, Helga; Moesgaard, Sophia Gry; Moore, Emma; Pasanen, Markku; Perry, Rick; Ragan, Ian; Robinson, Sally; Schmitt, Petra M.; Short, Brian; Lima, Beatriz Silva; Smith, Diane; Sparrow, Sue; van Bekkum, Yvette; Jones, David

Utility and importance of animal data in drug product labels

REGULATORY TOXICOLOGY AND PHARMACOLOGY

IF3.5

2014-08-015

PREAI

The evolution of juvenile animal testing for small and large molecules

REGULATORY TOXICOLOGY AND PHARMACOLOGY

IF3.5

2013-11-0112

PREAI

The design of chronic toxicology studies of monoclonal antibodies: Implications for the reduction in use of non-human primates

REGULATORY TOXICOLOGY AND PHARMACOLOGY