CROs conducting bioequivalence and bioavailability (BE/BA) studies for generics firms will have to log details of their sites with the US FDA under new ‘self-identification’ rules.
Drug regulators and the biomanufacturing industry need to embrace drug delivery via the skin to solve solubility problems with peptides and proteins, according to Across Barriers’ Udo Bock.
Pharmaceutics International (Pii) has expanded its range of formulation and process development services with the addition of bioavailability boosting hot-melt extrusion (HME) capabilities.