ABSTRACT
Pharmaceutical scientists are taking a fresh look at understanding underlying mechanisticbased scientific approaches in formulation development and manufacturing development. Pharmaceutical profiling is typically done to select the compound that not only has the desired drug activity, but also the physical, chemical, and biopharmaceutical properties that will translate into bioavailability in humans. The pharmaceutical scientist plays an important role in the selection of the vehicle for preclinical drug safety studies. Understanding polymorphism and hydrate formation is critical to the manufacturing and commercial success of a drug product. The pharmaceutical industry trends follow two approaches for First-in-human formulations: active-only formulations, e.g., powder-in-bottle or powderin-capsule approach, or traditional formulations. Once the stable dosage form is created, the formulation needs to be tested with respect to its robustness. A scientific rationale for package choice based on product requirements is an important part of the submission data package and also for manufacturing site Pre-approval inspections readiness.
