PharmTech AI Pulse Check panelists explain why attribution, audit trails, and sign-off matter more than AI watermark detection for GxP quality teams.
|Articles|April 22, 2020
Parenteral Drug Association (PDA)
Author(s)Parenteral Drug Association
PDA is the leading global provider of science, technology, regulatory information, and education for the bio/pharmaceutical community.
PDA is the leading global provider of science, technology, regulatory information, and education for the bio/pharmaceutical community. For more than 70 years, PDA has developed sound, practical technical information and resources to advance science and regulation through the expertise of our more than 10,500 members worldwide. We promote dialogue on new technology and regulations to ensure high-quality pharmaceutical production.
INTERPHEX Booth # 1653
Parenteral Drug Association (PDA)
4350 East West Hwy, Suite 600 Bethesda, MD 20814
info@pda.org
pda.org
tel. 301.656.5900
Related to this article
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.
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.
Trending on Pharmaceutical Technology
1
CPHI Milan 2026: Nitrosamine Risk Mitigation, Part 2
2
Pritelivir Shifts Resistant Herpes Care from Intravenous to Oral
3
Symptomatic Dermographism: Novartis Lands Remibrutinib Label Expansion
4
PharmTech AI Pulse Check: Availability Bias Threatens AI Regulatory Reviews
5