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 ...

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 ...

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 ...

Formulation development can involve several complex technical challenges, but an approach incorporating design of experiments can help address these difficulties. All pharmaceutical drug products are ...

General aspects of polynomial interpolation theory. Formulations in different basis, e.g. Lagrange, Newton etc. and their approximation and computational properties ...

Lipid nanoparticle formulation has increased over the past two decades. LNPs have proven to be effective nano-based delivery vehicles for cytotoxic chemotherapeutic drugs, nucleic acid therapies and ...

CAMBRIDGE, MA -- About 60 percent of drugs on the market have hydrophobic molecules as their active ingredients. These drugs, which are not soluble in water, can be difficult to formulate into tablets ...

Expertise in CMC (chemistry, manufacturing, and control) ensures the appropriate manufacture of a pharmaceutical or biologic by coordinating material characterization, formulation development, and ...

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 ...