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© 2022 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2022 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
November 02, 2022
Experts discuss factors that can affect the outcome of an ADME study, signs that a drug compound shows promise, red flags, and key parameters to determine safety and efficacy.
July 06, 2022
To ensure patient safety, drug products must be tested for elemental impurities that pose risk.
June 02, 2022
Analyzing elemental impurities in drug products is—much like other analytical testing—primarily aimed at ensuring patient safety.
December 01, 2021
Analytical methods need a boost to ensure quality control for cell and gene therapies.
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.
February 02, 2021
Common approaches to analyze elemental impurities for compliance with regulatory requirements are robust but still have some limitations.
January 02, 2021
Traditional biologic-based testing methods may need an upgrade to properly test newer therapeutic modalities.
September 22, 2020
Samsung will offer large-scale commercial manufacturing for drug substance and drug products to support AstraZeneca’s biologics therapeutics capabilities in the Asia-Pacific region.