Modeling Based Approaches to Support Generic Drug Regulatory Submissions-Practical Considerations and Case Studies

Modeling Based Approaches to Support Generic Drug Regulatory Submissions-Practical Considerations and Case Studies

Publication: AAPS J
Software: GastroPlus®

Model informed drug development (MiDD) is useful to predict in vivo exposure of drugs during various stages of the drug development process. This approach employs a variety of quantitative tools to assess the risks during the drug development process.

Evaluation of the anticancer potential of CD44 targeted vincristine nanoformulation in prostate cancer xenograft model: a multi-dynamic approach for advanced pharmacokinetic evaluation

Evaluation of the anticancer potential of CD44 targeted vincristine nanoformulation in prostate cancer xenograft model: a multi-dynamic approach for advanced pharmacokinetic evaluation

Publication: Cancer Nanotechnology
Software: ADMET Predictor®

The in vivo anticancer potential of vincristine (VC) loaded, thiolated chitosan-based nanoformulation (NFs) with an outer hyaluronic acid (VC-loaded in TCs-HA) coating was studied in prostate cancer (PC) xenograft in the immunosuppressed rat model induced by PC3 cell lines.

Predictive Potential of Acido-Basic Properties, Solubility and Food on Bioequivalence Study Outcome: Analysis of 128 Studies

Predictive Potential of Acido-Basic Properties, Solubility and Food on Bioequivalence Study Outcome: Analysis of 128 Studies

Publication: Drugs in R&D
Software: GastroPlus®

Risk assessment related to bioequivalence study outcome is critical for effective planning from the early stage of drug product development.

Modeling time‐delayed concentration‐QT effects with ACT ‐1014‐6470, a novel oral complement factor 5a receptor 1 (C5a 1 receptor) antagonist

Modeling time‐delayed concentration‐QT effects with ACT ‐1014‐6470, a novel oral complement factor 5a receptor 1 (C5a 1 receptor) antagonist

Publication: Pharmacology Research & Perspectives

The novel oral complement factor 5a receptor 1 antagonist ACT- 1014- 6470 was well tolerated in single- and multiple- ascending dose studies, including 24 h Holter electro-cardiogram (ECG) recordings evaluating its cardiodynamics based on data from singledoses of 30– 200 mg and twice- daily (b.i.d.) dosing of 30– 120 mg for 4.5 days.

Gastroplus and HSPiP Oriented Predictive Parameters as the Basis of Valproic Acid Loaded Mucoadhesive Cationic Nanoemulsion Gel for Improved Nose-To-Brain Delivery to Control Convulsion in Human

Gastroplus and HSPiP Oriented Predictive Parameters as the Basis of Valproic Acid Loaded Mucoadhesive Cationic Nanoemulsion Gel for Improved Nose-To-Brain Delivery to Control Convulsion in Human

Publication: Preprints.org
Software: GastroPlus®

Oral and parenteral delivery of first-line anticonvulsant Valproic cid (VA) are associated with serious adverse effects, high hepatic metabolism, high clearance, and low bioavailability in brain.

Simulation of drug-drug interactions between breast cancer chemotherapeutic agents and antiemetic drugs

Simulation of drug-drug interactions between breast cancer chemotherapeutic agents and antiemetic drugs

Authors: Deb S, Hopefl R
Publication: Daru Jour Pharma Sci
Software: GastroPlus®

Chemotherapy-induced nausea and vomiting are commonly experienced side effects in breast cancer (BCa) patients.

Development of Biopredictive Dissolution Method for Extended-Release Desvenlafaxine Tablets

Development of Biopredictive Dissolution Method for Extended-Release Desvenlafaxine Tablets

Publication: Pharmaceutics
Software: GastroPlus®

This study aimed to develop a biopredictive dissolution method for desvenlafaxine ER tablets using design of experiments (DoE)...

A Combined In-Vitro and GastroPlus® Modeling to Study the Effect of Intestinal Precipitation on Cinnarizine Plasma Profile in a Fasted State

A Combined In-Vitro and GastroPlus® Modeling to Study the Effect of Intestinal Precipitation on Cinnarizine Plasma Profile in a Fasted State

Publication: AAPS PharmSciTech
Software: GastroPlus®

Poorly water-soluble weak base molecules such as cinnarizine often exhibit pH-dependent solubility within the gastrointestinal tract.

Pan-genome mediated therapeutic target mining in Kingella kingae and inhibition assessment using traditional Chinese medicinal compounds: an informatics approach

Pan-genome mediated therapeutic target mining in Kingella kingae and inhibition assessment using traditional Chinese medicinal compounds: an informatics approach

Authors: Basharat Z, Meshal A
Publication: J Biomol Struct Dyn
Software: GastroPlus®

Kingella kingae causes bacteremia, endocarditis, osteomyelitis, septic arthritis, meningitis, spondylodiscitis, and lower respiratory tract infections in pediatric patients