| PEER-REVIEWED RESEARCH |
Lei Lei and Pramote Cholayudth
The article reports on the CuDAL-Excel program, a set of MS Excel programs transformed and extended from Bergum’s CuDAL version 2 SAS program, designed for industry practitioners to calculate the USP passing probability of content uniformity and dissolution tests for both sampling plan 1 and sampling plan 2 scenarios, and for both immediate release and extended release requirements.
/ read more /
| MANUFACTURING |
Jennifer Markarian
Equipment and process optimization must be considered for scaling up these developmental technologies to commercial production.
/ read more /
| QUALITY/REGULATIONS |
Lauren Lavelle
Organizations involved in aseptic and sterile processing activities must make an effort to comply with current good manufacturing practices.
/ read more /
Felicity Thomas
Industry must never become complacent about the safety of drug products and should seek to continually perform surveillance even if the drug is well-established.
/ read more /
| EDITOR'S COMMENT |
Felicity Thomas
In light of the hype around chloroquine and hydroxychloroquine as potential COVID-19 treatments, it is important to remember that drug repurposing should never be rushed, irrespective of the urgency of the situation.
/ read more /
| EUROPEAN REGULATORY WATCH |
Sean Milmo
EMA’s strategy for regulatory science has divided opinion amongst various industry bodies.
/ read more /
| ASK THE EXPERT |
Siegfried Schmitt
Having a better understanding about compliance will be of benefit when looking for a job or for furthering one’s career, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
/ read more /
|
