Quality by design is an essential part of the modern approach to pharmaceutical quality.
There is much confusion among pharmaceutical scientists in generic drug industry about the …

Crystallizations of pharmaceutical active ingredients, particularly those that posses multiple
polymorphic forms, are among the most critical and least understood pharmaceutical …

We present a theoretical framework for the viscosity of bimodal and polydisperse colloidal
suspensions. For colloidal dispersions both interparticle forces between pairs of particles and …

To implement Quality by Design (QbD) in drug development, scientists need tools that link
drug products properties to in vivo performance. Physiologically based absorption models are …

FDA’s critical path initiative documents have focused on the challenges involved in the
development of new drugs. Some of the focus areas identified apply equally to the production of …

Highly variable (HV) drugs are defined as those for which within-subject variability (%CV) in
bioequivalence (BE) measures is 30% or greater. Because of this high variability, studies …

International regulatory agencies have developed recommendations and guidances for
bioequivalence approaches of orally inhaled drug products (OIDPs) for local action. The …

Advances in predicting in vivo performance of drug products has the potential to change
how drug products are developed and reviewed. Modeling and simulation methods are now …

Regulatory science is science and research intended to improve decision making in a
regulatory framework. Improvements in decision making can be in both accuracy (making better …

For ophthalmic drug products, the determination of bioequivalence can be challenging, as
drug concentrations at the site of action cannot always be measured. The FDA has …