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 ...

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 ...

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 ...

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 ...

Spray-dried protein microparticles without MoNi surfactant form paste-like materials (left), whereas those spray dried with MoNi surfactant form injectable suspensions that flow like liquids (right).

When designing stability protocols, formulation, storage, and dosing conditions must be assessed. Establishing adequate stability of a preclinical dose formulation is a crucial component of drug ...

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 ...

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 ...