Paul Baldrick

Biocompatibility assessments for medical devices – evolving regulatory considerations

Lesley Reeve, Paul Baldrick, Lesley Reeve, 2017, Expert review of medical devices.

Preclinical development of monoclonal antibodies

Ian Ragan, Kathryn Chapman, Colin Green, 2009, mAbs.

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

Jennifer Sims, Ian Ragan, Kathryn Chapman, 2016, mAbs.

Safety evaluation to support First-In-Man investigations II: toxicology studies.

Paul Baldrick, P. Baldrick, 2008, Regulatory toxicology and pharmacology : RTP.

Safety evaluation of biological drugs: what are toxicology studies in primates telling us?

Paul Baldrick, P. Baldrick, 2011, Regulatory toxicology and pharmacology : RTP.

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

Jennifer Sims, Paul Baldrick, Kathryn L Chapman, 2012, Regulatory toxicology and pharmacology : RTP.

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.

Fiona Sewell, Sally Robinson, Beatriz Silva Lima, 2014, Regulatory toxicology and pharmacology : RTP.

Toxicokinetics in preclinical evaluation.

Paul Baldrick, P. Baldrick, 2003, Drug discovery today.