Xiaorong He, Ph.D., M.B.A., Ajit Narang, Ph.D., Steven X. Hu, Ph.D., John McQuaid, Rao Tatapudy, R.Ph., Ph.D.
XH: Outsourcing need of formulation development is usually assessed based on internal capacity and capability considerations.
Francis Dumont
The Request for Information/Request for Proposal (RFI/RFP) process for evaluating sourcing partners is well established and has been successfully utilized within the Pharmaceutical Industry.
Gilbert J. Burckart, Pharm.D., Allen Rudman, Ph.D.
Safety studies are required for all drugs undergoing testing in pediatric patients. While efficacy can be extrapolated in some cases on the basis of adult studies, safety studies must be separately conducted in pediatric patients.
William Downey, MBA, Helen Nicely, Ph.D.
The market for biopharmaceuticals continues to expand in both volume and revenue.
Steve Sweeney
Effectively managing biospecimens along with their associated data are key components of efficient clinical development.
Nigel Walker
In terms of differentiating from competitors through marketing, CROs and CMOs serving pharmaceutical and biopharmaceutical outsourcing markets need to recognize that data shows there’s a fundamental difference between black and white regulatory compliance and the regulatory perceptions that might influence outsourcing decisions.
E. David G. McIntosh, Ph.D.
The purpose of this review is to discuss general issues that need to be taken into consideration when planning a pediatric study.
Kevin Mulligan
An environmental revolution is underway that will impact communities, governments and businesses across the globe.