This report summarizes the proceedings for Day 3 of workshop titled “Current State and Future Expectations Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes Controls”. From a drug product quality perspective, patient-centric development necessitates clinically relevant specifications (CRDPS). In this regard, Physiologically Based Biopharmaceutics model...

Low water solubility and high permeability present formulation challenges for drugs categorized as Biopharmaceutics Classification System (BCS) Class II, resulting in reduced bioavailability. This research focuses on addressing the issues of BCS II drugs, including Simvastatin, Ketoprofen, griseofulvin, ibuprofen, ketoconazole, carbamazepine, which exhibit but poor solubility. A potential strat...

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing isoniazid as the only active pharmaceutical ingredient (API) are reviewed. Isoniazid's solubility and permeability characteristics according to the Biopharmaceutics Classification System (BCS), as well as its therapeutic ...

The metabolic capacity of the intestine and its importance as the initial barrier to systemic exposure can lead to underestimation of first-pass, and thus overestimation of oral bioavailability. However, the in vitro tools informing estimates of in vivo intestinal metabolism are limited by the complexity of the in vitro matrix preparation and uncertainty with the scaling factors for in vitro to...

Literature data pertaining to the decision to allow a waiver of in vivo bioequivalence testing for the approval of immediate-release (IR) solid oral dosage forms containing efavirenz as the only active pharmaceutical ingredient (API) are reviewed. Because of lack of conclusive data about efavirenz's permeability and its failure to comply with the "high solubility" criteria according to the Biop...

A biowaiver monograph for acetylsalicylic acid (ASA) is presented. Literature and experimental data indicate that ASA is a highly soluble and highly permeable drug, leading to assignment of this active pharmaceutical ingredient (API) to Class I of the Biopharmaceutics Classification System (BCS). Limited bioequivalence (BE) studies reported in the literature indicate that products that have bee...