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 ...

Artificial intelligence and machine learning can help overcome poor solubility and bioavailability. Artificial intelligence (AI) and machine learning (ML) in the biopharmaceutical industry have been ...

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 ...

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 ...

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 ...

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 ...

Stability is a critical factor in drug formulation, with implications for product quality, lifecycle management, and ...