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© 2022 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2022 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
June 03, 2022
This article describes the in-vitro permeation test study data processing procedures and FDA statistical mathematics of evaluating a generic topical drug product, acyclovir cream, against its reference product.
June 02, 2022
Analyzing elemental impurities in drug products is—much like other analytical testing—primarily aimed at ensuring patient safety.
June 01, 2022
Dissolution testing has seen recent trends that have led to increased data integrity solutions as well as an increase in biorelevant testing techniques.
FDA continues efforts to incentivize drug manufacturers to follow higher data integrity requirements.
May 04, 2022
The “cloud lab” is a virtual laboratory setting that can enable scientists to more quickly advance research.
May 03, 2022
Using more exacting analytical tools can give a clearer assessment of gene-editing outcomes.
April 06, 2022
The challenges of conducting protein characterization can be overcome through the use of technologies that empower scientists in their analytical work.
April 03, 2022
The author introduces a practical approach to determining the best estimate of probability for passing multiple stage dissolution tests.
March 16, 2022
Any improper validation of methods is likely to result in regulatory agency deficiencies that range in degree of severity.
March 15, 2022
The importance of getting buy-in from regulatory authorities early in the development process is critical in order to establish meaningful specifications.