Formulation Development

FORMULATION FORUM - Revitalization of Older Drug Products Using Innovative Formulation Technologies by 505(b)(2) Regulatory Pathway

Jim Huang, PhD, says more than 50% of approved drugs on the market contain poorly water soluble APIs, which typically are associated with poor bioavailability, suboptimal drug delivery, ineffective drug efficacy, and side effects, and this creates a huge opportunity in generating 505(b)(2) products.