by RJTimko | Jan 22, 2024 | Processing
The discovery, development and commercialization of a novel drug entity is not a quick or easy endeavor. Many compounds fail during safety and/or clinical testing for a variety of reasons. In addition, the compound may demonstrate chemical or physical characteristics...
by RJTimko | Jul 19, 2018 | Processing
Formulation and process development can be a complex and a time-consuming effort. It can take months depending on the physical and chemical properties of the active pharmaceutical ingredient and the complexity of the dosage form being developed. To assist companies...
by RJTimko | Sep 28, 2017 | Processing
Extended in process hold times for drug product intermediates could have an overall impact on the commercial ‘shelf-life’ (not expiry date) of your product. Establishing Date of Manufacture According to FDA, a 30-day period from the Date of Manufacture to the...
