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 ...

Appropriate use of sound science applied at critical junctures will improve efficiency in the high-wire act of drug development. Pharmaceutical companies walk a tightrope in early drug development.

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...