Mark Alasandro
Articles
Method Validation by Design to Support Formulation Development
April 2nd 2013The 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 space that allows for formulation changes without revalidation.
A two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC.
A two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC.
Early Development GMPs for Stability (Part IV)
IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development, with a focus on stability.
