Ron Scarboro, Azurity Pharmaceuticals, explains how cross-functional development, disciplined reformulation, and post-approval metrics can help proven medicines work in everyday use.
|Articles|February 2, 2019
Connecting People, Science, and Regulation®
The Parenteral Drug Association (PDA) is the leading global provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical community.
Advertisement
The Parenteral Drug Association (PDA) is the leading global provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance bio/pharmaceutical science and regulation through the expertise of its more than 10,000 members worldwide, so members can better serve patients.
PDA Booth: 716
Advertisement
Related to this article
The FDA approves oral pritelivir for drug-resistant herpes sores in immunocompromised patients; what it means for antiviral development and manufacturing.
This week, drug formulation and manufacturing experts showcased their knowledge, and companies exhibited their products, at CPHI Milan.
FDA approves Teva’s Weltruza, a once-monthly subcutaneous olanzapine for schizophrenia whose copolymer depot eliminates post-injection monitoring.
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.
Richard Jaenisch examines whether FDA's NAM pathway truly shortens drug pipelines or just shifts the evidentiary burden elsewhere.
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.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
Pritelivir Shifts Resistant Herpes Care from Intravenous to Oral
2
What the Olanzapine Depot Approval Means for CMC Teams
3
PharmTech AI Pulse Check: Availability Bias Threatens AI Regulatory Reviews
4
Complying with International Pharmacopoeias
5