August 2004

Ravi Kiran Kaja, PhD, explains how USP’s industry-wide initiative aims to build confidence in trace-level extractables and leachables results.

AI accountability, faster FDA pathways, rare disease CMC review, and next-gen GLP-1 formulation lead this week’s PharmTech roundup.

Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.

This article examines how modern automation platforms create the digital foundation required for Pharma 4.0 by integrating manufacturing systems, centralized data management, Industrial Internet of Things connectivity, electronic batch production records, and AI-driven analytics.

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.

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.