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Trends In Medicine

Single-Use Bioreactors Pose E&L Challenges

Derek Wood comments on the challenges posed by single-use bioreactor bags in contributing to extractables and leachables in the biomanufacturing process.

BioPharm International  (December 2017)

Marketing applications for biopharmaceuticals: Considerations for different jurisdictions – Part 2

In this two-part series, John Watkins and Clare Ryder highlight the similarities and differences in global submission requirements.

Regulatory Rapporteur  (November 2017)

The Virtual Opportunity in Rare Disease Trials

In this article written by Karen Kaucic, Horacio Plotkin and Christopher Komelasky, the authors discuss how rare disease research can be solved with virtual trials and their supporting technologies.

Applied Clinical Trials  (November 2017)

Analytical Testing – Extractables and Leachables Testing for Pharmaceutical Products

Xiaochun Yu and Derek Wood provide a detailed overview of extractables and leachables.

Pharmaceutical Outsourcing  (November 2017)

A rare journey: Managing the regulatory landscape

Jonca Bull discusses the significant regulatory actions that have occurred in the rare disease space.

PharmaVOICE  (October 2017)

Tracking adoption of risk assessment and RBM

Nicole Stansbury, executive director, discusses risk-based monitoring in the clinical trial industry with CenterWatch Monthly.

CenterWatch Monthly  (October 2017)

Marketing applications for biopharmaceuticals: Considerations for different jurisdictions – Part 1

In this two-part series, John Watkins and Clare Ryder highlight the similarities and differences in global submission requirements.

Regulatory Rapporteur  (October 2017)

Bending the Cost and Time Curve of Drug Development through the Use of Biomarkers

In this article written by Katie Matys and Janine McKnight, the authors discuss how the right biomarker can make all the difference in a drug-development program.

Genetic Engineering & Biotechnology News   (October 2017)

How Interested Is The FDA In Real-World Evidence?

Radek Wasiak of Evidera comments on real-world evidence in part three of this three-part series.

Clinical Leader  (September 2017)

Real-World Evidence & The 21st Century Cures Act — What You Need To Know

Radek Wasiak of Evidera comments on real-world evidence in part two of this three-part series.

Clinical Leader  (September 2017)

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