OR WAIT null SECS
April 01, 2020
Tools help improve understanding of excipient risk in formulating OSD drugs.
January 02, 2020
Focusing on symptoms instead of root causes locks teams into a corrective, rather than preventive, mindset.
December 15, 2019
Long a staple for quality by design and solid dosage form manufacturing, design of experiments is becoming an integral part of biopharma upstream process development.
Too narrow a focus on regulatory compliance may prevent organizations from embracing-and profiting from-quality and operational excellence.
December 02, 2019
Regulators are facing huge challenges on how to deal with the digitalization transformation occurring in the healthcare and pharmaceutical sectors.
As equipment evolves and use of PAT increases, DOE is becoming an integral part of upstream bioprocess development.
November 08, 2019
As they seek to increase the number of generics available, regulators are requiring that in-vitro and other test data be used for ANDAs, and promoting the concept of biowaivers that would allow such data to replace costly clinical studies.
September 15, 2019
A GAO report analyzes some of the reasons why so few generics are approved the first time around. NIPTE has proposed a program that would address these issues.
Validation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies.
August 02, 2019
Harmonization of regulatory guidelines not only reduces workloads for manufacturers and regulators but can potentially help to accelerate patient access to vital therapies.