Drug delivery is an important factor for the success of ocular drug treatment.
Optimization of wet granulation process for manufacturing Rivaroxban generic immediate-release tablets using PBPK modeling and simulations
Granulation is the critical process for the pharmaceutical development of poorly water-soluble drug products.
A Semi-Mechanistic Physiologically Based Biopharmaceutics Model to Describe Complex and Saturable Absorption of Metformin: Justification of Dissolution Specifications for Extended Release Formulation
Physiologically based pharmacokinetic (PBPK) or physiologically based biopharmaceutics models (PBBM) demonstrated plethora of applications in both new drugs and generic product development.
Novel omeprazole delayed release orally disintegrating tablets for enhanced patient compliance: a case of model informed formulation development
The advanced in silico simulation tools, such as physiologically based biopharmaceutics models (PBBM) or physiologically based pharmacokinetic models (PBPK), play critical role in model informed formulation development.
A Physiologically Based Pharmacokinetic Model of Voriconazole in Human CNS —— Integrating Time-Dependent Inhibition of CYP3A4, Genetic Polymorphisms of CYP2C19 and Possible Transporter Mechanisms
Voriconazole is a classical antifungal drug that is often used to treat CNS fungal infections due to its permeability through the BBB.
Design and Evaluation of 3-Phenyloxetane Derivative Agonists of the Glucagon-Like Peptide-1 Receptor
Various small molecule GLP1R agonists have been developed and tested for treating type 2 diabetes (T2DM) and obesity.
Comparison of drug-induced liver injury risk between propylthiouracil and methimazole: A quantitative systems toxicology approach
Propylthiouracil (PTU) and methimazole (MMI), two classical antithyroid agents possess risk of drug-induced liver injury (DILI) with unknown mechanism of action.
Redefining Statin Dosage Post-Gastric Bypass: Insights from a Population Pharmacokinetics–Pharmacodynamics Link Approach
Roux-en-Y gastric bypass (RYGB) involves creating a small stomach pouch, bypassing part of the small intestine, and rerouting the digestive tract.
Scaling approaches for the prediction of human clearance of LNA-i-mir-221: A retrospective validation
LNA-i-miR-221 is a novel microRNA(miRNA)-221 inhibitor designed for the treatment of human malignancies.
Computational approach for drug discovery against Gardnerella vaginalis in quest for safer and effective treatments for bacterial vaginosis
Bacterial vaginosis (BV), primarily attributed to Gardnerella vaginalis, poses significant challenges due to antibiotic resistance and suboptimal treatment outcomes.
Development and Application of a Physiologically Based Pharmacokinetic Model for Elagolix in the Adult and Adolescent Population
Endometriosis, a common and distressing gynecological condition, affects fertility and causes pain, is often managed with medications such as Elagolix.
Oral Absorption from Surfactant-Based Drug Formulations: The Impact of Molecularly Dissolved Drug on Bioavailability
Enabling drug formulations are often required to ensure sufficient absorption after oral administration of poorly soluble drugs.
Cellulose ether and carbopol 971 based gastroretentive controlled release formulation design, optimization and physiologically based pharmacokinetic modeling of ondansetron hydrochloride minitablets
This study aims to design and optimize ondansetron (OND) gastro-retentive floating minitablets for better and prolonged control of postoperative nausea and vomiting (PONV) with improved patient compliance.
Establishing Virtual Bioequivalence and Clinically Relevant Specifications for Omeprazole Enteric-Coated Capsules by Incorporating Dissolution Data in PBPK Modeling
Currently, Biopharmaceutics Classification System (BCS) classes I and III are the only biological exemptions of immediate-release solid oral dosage forms eligible for regulatory approval.
Clinical Ocular Exposure Extrapolation for a Complex Ophthalmic Suspension Using Physiologically Based Pharmacokinetic Modeling and Simulation
The development of generic ophthalmic drug products with complex formulations is challenging due to the complexity of the ocular system and a lack of sensitive testing to evaluate the interplay of its physiology with ophthalmic drugs.
Effect of Hepatic Impairment on Trofinetide Exposures Using an In Silico Physiologically Based Pharmacokinetic Model
Trofinetide is the first drug to be approved for the treatment of Rett syndrome.
Advancing Virtual Bioequivalence for Orally Administered Drug Products: Methodology, Real-World Applications and Future Outlook
Bioequivalence studies are pivotal in generic drug development wherein therapeutic equivalence is provided with an innovator product.
The Synthetic Cathinones MDPHP and MDPV: Comparison of the Acute Effects in Mice, in silico ADMET Profiles and Clinical Reports
The 3,4-methylenedioxy-alpha-pyrrolidinohexanophenone (MDPHP) is a synthetic cathinone closely related to 3,4-methylenedioxypyrovalerone (MDPV), one of the most common synthetic cathinones present in the "bath salts".
Toward Personalized Salbutamol Therapy: Validating Virtual Patient-Derived Population Pharmacokinetic Model with Real-World Data
Interindividual variability, influenced by patient-specific factors including age, weight, gender, race, and genetics, among others, contributes to variations in therapeutic response.
Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report
This Article shares the proceedings from the August 29th, 2023 (day 1) workshop “Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives”.