For successful oral drug development, defining a bioequivalence (BE) safe space is critical
for the identification of newer bioequivalent formulations or for setting of clinically relevant in …

Bioequivalence studies are pivotal in generic drug development wherein therapeutic
equivalence is provided with an innovator product. However, bioequivalence studies …

This study investigated the impact of gastro-intestinal fluid volume and bile salt (BS)
concentration on the dissolution of carbamazepine (CBZ) immediate release (IR) 100 mg …

For centuries, Traditional Chinese Medicine (TCM) has been a prominent treatment method
in China, incorporating acupuncture, herbal remedies, massage, and dietary therapy to …

Studies that focus on individual covariates, while ignoring their interactions, may not be
adequate for model‐informed precision dosing (MIPD) in any given patient. Genetic …

Gastric mechanical stress often impacts drug dissolution from solid oral dosage forms, but in
vitro experiments cannot recreate the substantial variability of gastric motility in a reasonable …

The proceedings from the 30th August 2023 (Day 2) of the workshop “Physiologically Based
Biopharmaceutics Models (PBBM) Best Practices for Drug Product Quality: Regulatory and …

Virtual bioequivalence trial (VBE) simulations based on (semi) mechanistic in vitro-in vivo
(IVIV) modeling have gained a huge interest in the pharmaceutical industry. Sophisticated …

Biorelevant dissolution tests of oral solid dosage forms open the gate to valid in vitro-in vivo
predictions (IVIVP). A recently developed apparatus, PhysioCell, allows mimicking the fluid …

Objective To recommend precision dosing and improve therapeutic efficacy against invasive
fungal disease, a physiologically based pharmacokinetic model (PBPK) of oral …