Articles by Mark Alasandro - Pharmaceutical Technology

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Articles by Mark Alasandro

Mark Alasandro


Articles
Multifactor Non-linear Modeling for Accelerated Stability Analysis and Prediction
July 2, 2014

The right approach can provide a clear, statistically defendable method for determining dissolution and accelerated stability.

Method Validation by Design to Support Formulation Development
April 2, 2013

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 space that allows for formulation changes without revalidation.

Pharmaceutical Stability: Scientific and Regulatory Considerations for Global Drug Development and Commercialization
November 3, 2012

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.

AAPS Workshop Summary
November 2, 2012

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)
September 2, 2012

IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development, with a focus on stability.

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