The US Food and Drug Administration (FDA) has released a new final guidance document regarding how regulators plan to classify pharmaceutical products that are made of solid-state co-crystals, a novel ...

To optimize the final formulation for a drug, it must meet many criteria beyond producing a safe and effective product. For example, it must be stable and amenable to various manufacturing steps, such ...

Scientists have successfully tested the use of machine learning models to guide the design of long-acting injectable drug formulations. The potential for machine learning algorithms to accelerate drug ...

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

Suzanne Jansen, MSc, PharmD, ICON, says early-phase clinical success depends on flexible, simple formulations that support wide dose ranges, matching placebos, and robust stability. Formulations are ...

High-concentration formulations and patient centricity are challenges to the formulation of biosimilars, which already face patent protection barriers. Biosimilar formulation development requires ...