Pharma and biotech companies strive to accelerate clinical trials to reduce their costs while continuing to meet unmet medical needs. In this Tech Talk video series, PPD’s industry scientists share improvements to clinical trials using innovative data solutions and technological advancements within the central lab.In the 2nd video of the series, Chris Clendening, SVP, lab operations, PPD® Laboratory services, and Tim Rich, VP, PPD Digital and Decentralized solutions, discuss the importance of direct-to-patient and direct-from-patient shipments as it pertains to the intersection of decentralized clinical trials (DCTs).
Ron Scarboro, Azurity Pharmaceuticals, explains how cross-functional development, disciplined reformulation, and post-approval metrics can help proven medicines work in everyday use.
The FDA approves oral pritelivir for drug-resistant herpes sores in immunocompromised patients; what it means for antiviral development and manufacturing.
Equivalence test using two one-sided tests are widely used for demonstrating the comparability of treatment effects in different research fields. The method described in the manuscript aims to use simulations in Microsoft Excel to compute power for 2 one-sided tests for two groups with unequal variances.
Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel, clear up some of the confusion about what does and does not need to be complied with regarding standards set by international pharmacopoeias.
Mitigating nitrosamine risk requires assessing each product individually, says Bram Baert, Global Head of Regulatory Affairs at Capsugel, and Sandrine Picco, Senior Analytical Specialist on Capsugel's Innovaform Accelerator Team, in this interview with PharmTech.