It is estimated that 70% to 80% 1 of small molecule drug candidates in development today can be classified as poorly water-soluble. Since poorly soluble drugs are difficult to formulate as tablets, ...

The FDA has updated its draft guidance on bioequivalence studies with fresh advice for developers of drugs in a range of dosage forms. Publication of the updated draft comes almost eight years after ...

Patient-centric drug development improves adherence and outcomes by focusing on patient needs and preferences, with regulatory support from bodies like the FDA. Special populations, including ...

FDA proposals include ‘major updates’ to simplify biosimilarity studies, reduce unnecessary clinical testing, and ease the ...

Administering medications to children poses unique challenges, especially in resource-limited countries with high infant and child mortality rates. Many drugs are solids or tablets, which are not ...