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© 2022 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2022 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
December 01, 2021
Analytical methods need a boost to ensure quality control for cell and gene therapies.
November 02, 2021
Automatic visual inspection machines and artificial intelligence highlight inspection deficits for parenteral containers and units.
October 02, 2021
Although stability testing programs for small-molecule drugs and biologics are often perceived as similar, stability programs for biologics are far more complex.
April 02, 2021
A well-chosen replication strategy can effectively reduce the uncertainty for an analytical method, enabling appropriate decisions regarding pharmaceutical quality.
Despite its importance in drug development, dissolution testing still has some limitations, but advances in automation and real-time monitoring are producing promising results.
March 16, 2021
February 02, 2021
Common approaches to analyze elemental impurities for compliance with regulatory requirements are robust but still have some limitations.
August 01, 2020
Carcinogenic compounds have been found in a number of top-selling drugs, leading to recalls and bans. Preventing problems requires working closely with contract testing and development partners as well as API and other suppliers.
June 02, 2020
The correct mix of excipients is crucial to the success of fast dissolving/orally disintegrating dosage forms.
April 01, 2020
With new tests showing NDMA levels increase under normal storage conditions, FDA calls for removal of ranitidine products from the market.