Outsourcing projects to CDMOs is becoming increasingly prevalent as drug
sponsors look to optimize their supply chain or conserve internal resources
for other projects. In 2021 alone, 46% of newly developed drugs were
outsourced. Drug sponsors can reap a variety of benefits by outsourcing
late-phase projects, but it comes with risks. The technology transfer that
must occur to transition a late-phase project to a CDMO is complex and
costly. The average cost of a tech transfer is around $1M, so partnering
with the wrong CDMO can be a costly mistake.
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.