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 ...

Discover how early CMC, process optimization, and formulation strategy drive scalable, commercially viable drugs.

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 ...

A new nanomedicine formulation method that uses the active pharmaceutical ingredient (API) as a scaffold rather than a separate matrix is a big breakthrough for biopharmaceutical manufacturers, says ...

High level of microorganisms should not be present in non-sterile products for human use as they may cause adverse incidents. As an expert specializing in drug formulation, CD Formulation announces to ...

PharmTech spoke with Dr. Asma Patel, VP Global Commercial and Scientific Consulting–Drug Product, to find out how the growth ...

Adam Hayes, Ph.D., CFA, is a financial writer with 15+ years Wall Street experience as a derivatives trader. Besides his extensive derivative trading expertise, Adam is an expert in economics and ...

(Boca Raton, Florida) Stellar Materials LLC has introduced a new line of refractory products called the Thermbond 7200 Series that can substantially reduce the cost of most furnace repairs through its ...

Patients with some cancers, autoimmune diseases, and metabolic disorders often endure time-consuming intravenous (IV) infusions to receive the best protein-based treatments available. Because these ...

Mathematics of Computation, Vol. 79, No. 272 (OCTOBER 2010), pp. 2001-2032 (32 pages) We derive in this paper a unified framework for a priori and a posteriori error ...