Nonclinical dose formulation analysis methods are used to confirm test article concentration and homogeneity in formulations and determine formulation stability in support of regulated nonclinical ...
It is crucial to have a tight formulations control process in any laboratory environment. A robust formulations management plan can help to meet specifications, ensure product quality, and decrease ...
The authors describe a method-validation-by-design (MVbD) approach to validate a method over a range of formulations using both design-of-experiment and quality-by-design principles to define a design ...
Impact of Quality by Design on Topical Product Excipient Suppliers, Part II: Reasonable Expectations
This article will clarify reasonable expectations for the responsibilities of topical product formulation developers and for excipient suppliers regarding the information and samples for experiments ...
ALBANY, New York, Jan. 19, 2015 /PRNewswire/ -- AMRI (AMRI) today announced it received a 10-year federal contract award from the National Institutes of Health (NIH) for drug development and ...
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