A phase I dose-escalation study of oxaliplatin delivered via a laparoscopic approach using pressurised intraperitoneal aerosol chemotherapy for advanced peritoneal metastases of gastrointestinal tract cancers

A phase I dose-escalation study of oxaliplatin delivered via a laparoscopic approach using pressurised intraperitoneal aerosol chemotherapy for advanced peritoneal metastases of gastrointestinal tract cancers

Authors: Dumont F, Raoul JL, Kepenekian V, Lelievre B, Boisdron-Celle M, Hiret S, Senellart H, Pein F, Blanc-Lapierre A, Raimbourg J, Thibaudeau E, Passot C
Publication: Eur J Cancer
Keywords: haematologic, intraperitoneal, pharmacokinetics, PIPAC, tumours
Software: PKanalix®
Division: Clinical Pharmacology and Pharmacometrics (CPP)

The objectives were to define the maximum tolerated dose (MTD), safety profile and pharmacokinetics (PKs) of intraperitoneal oxaliplatin delivered by pressurized intraperitoneal...

Development of physiologically-based pharmacokinetic models for standard of care and newer tuberculosis drugs

Development of physiologically-based pharmacokinetic models for standard of care and newer tuberculosis drugs

Authors: Humphries H, Almond L, Berg A, Gardner I, Hatley O, Small B, Zhang M, Jamei M, Romero K, Pan X
Publication: CPT Pharmacometrics Syst Pharmacol
Keywords: and rifapentine, cycloserine, ethambutol, ethionamide, isoniazid, kanamycin, Linezolid, physiologically based pharmacokinetic modeling, pyrazinamide, Rifampicin
Software: GastroPlus®
Division: PBPK

Tuberculosis (TB) remains a global health problem and there is an ongoing effort to develop more effective therapies and new combination regimes that can reduce duration of treatment.

Relationship Between Pimavanserin Exposure and QTc Interval in Patients with Schizophrenia: Modelling Analysis from Randomized, Double-Blind, Placebo-Controlled Studies

Relationship Between Pimavanserin Exposure and QTc Interval in Patients with Schizophrenia: Modelling Analysis from Randomized, Double-Blind, Placebo-Controlled Studies

Authors: Darwish M, Bugarski-Kirola D, Passarell JA, Fellows Maxwell K, Owen JS, DeKarske D, Stankovic S
Conference: European College of Neuropsychopharmacology (ECNP) Congress
Keywords: 5-HT2A receptors, 5-HT2C receptors, ADVANCE, antipsychotic treatment, antipsychotics, ENHANCE, exposure-response, pimavanserin, QTc, schizophrenia
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Patients with schizophrenia who are receiving more than one antipsychotic may be at higher risk for QT interval...

Pharmacokinetics of Baclofen in a Full-Term Newborn after Intrauterine Exposure: A Case Report

Pharmacokinetics of Baclofen in a Full-Term Newborn after Intrauterine Exposure: A Case Report

Authors: Balakirouchenane D, Khoudour D, Chouchana D, Chevillard L, Declèves X
Publication: Neanotology
Keywords: fetal exposure, gastroplus, PBPK modeling, pediatrics, physiologically based pharmacokinetics, population simulations, pregnancy
Software: GastroPlus®

Intrauterine exposure to baclofen can lead to syndrome of withdrawal during the first days of the newborn.

A new phenothiazine derivate is active against Clostridioides difficile and shows low cytotoxicity

A new phenothiazine derivate is active against Clostridioides difficile and shows low cytotoxicity

Authors: Ronco T, Aragao FM, Saaby L, Permin A, Thamsborg SM, Olsen RH
Publication: PLoS One
Keywords: first-in-human, gastroplus, pbbm, PBPK modeling, physiologically based pharmacokinetics, safety assessment
Software: GastroPlus®

The rapid evolution of antibiotic resistance in Clostridioides difficile and the consequent effects on prevention and treatment of C.

Slower degradation rate of cytarabine in blood samples from acute myeloid leukemia by comparison with control samples

Slower degradation rate of cytarabine in blood samples from acute myeloid leukemia by comparison with control samples

Authors: Abbara C, Drevin G, Ferec S, Ghamrawi S, Souchet S, Robin JB, Schmidt A, Hunault-Berger M, Guardiola P, Briet M
Publication: Cancer Chemother Pharmacol
Keywords: AML, Cytarabine, in vitro, linear regression model, myeloid Leukemia
Software: PKanalix®
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Cytarabine, a key chemotherapy agent for acute myeloid leukemia (AML) treatment, is deaminated into inactive uracil-arabinoside by cytidine deaminase.

Dose Selection for Fremanezumab (AJOVY) Phase 3 Pediatric Migraine Studies Using Pharmacokinetic Data From a Pediatric Phase 1 Study and a Population Pharmacokinetic Modeling and Simulation Approach

Dose Selection for Fremanezumab (AJOVY) Phase 3 Pediatric Migraine Studies Using Pharmacokinetic Data From a Pediatric Phase 1 Study and a Population Pharmacokinetic Modeling and Simulation Approach

Authors: Cohen-Barak O, Radivojevic A, Jones A, Fiedler-Kelly J, Gillespie M, Brennan M, Gutman D, Rasamoelisolo M, Hallak H, Loupe P, Kessler Y, Ning X, Levi M, Ahn AH, Rabinovich-Guilatt L
Publication: Cephalalgia
Keywords: calcitonin-gene-related peptide, CGRP, fremanezumab, migraine, pediatric dosing, population pharmacokinetics
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Potential fremanezumab doses for pediatric patients were evaluated using pharmacokinetic modeling and

Pharmacokinetics of Pantoprazole and Pantoprazole Sulfone in Goats After Intravenous Administration: A Preliminary Report

Pharmacokinetics of Pantoprazole and Pantoprazole Sulfone in Goats After Intravenous Administration: A Preliminary Report

Authors: Smith J, Mochel JP, Soto Gonzalez W, Rahn R, Fayne B, Escher O, Geletka A, Harvill L, Bergman J
Publication: Front Vet Sci
Keywords: goat (capra aegagrus hircus), pantoprazole, pantoprazole sulfone, pharmacokinetics, ulcer
Software: PKanalix®
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Ruminant species are at risk of developing abomasal ulceration, but there is a lack of pharmacokinetic data for anti-ulcer therapies, such as the proton pump inhibitor pantoprazole, in...

Developing a PBPK modeling approach for evaluating drug product performance in infants based on adults data

Developing a PBPK modeling approach for evaluating drug product performance in infants based on adults data

Authors: Vertzoni M, Statelova M, O’Connor D, Suarez-Sharp S, Nevarez J
Keywords: drug efficacy, drug product performance, PBPK modeling, pediatrics, U.S. FDA, University+, University+ Program
Software: GastroPlus®
Division: PBPK

Understanding drug and drug formulation performance in relation to the prandial conditions is essential for ensuring the safety and efficacy of products to be administered to pediatric patients, especially newborns...

Establishing the Bioequivalence Safe Space for Immediate-Release Oral Dosage Forms Using Physiologically Based Biopharmaceutics Modeling (PBBM): Case Studies

Establishing the Bioequivalence Safe Space for Immediate-Release Oral Dosage Forms Using Physiologically Based Biopharmaceutics Modeling (PBBM): Case Studies

Authors: Heimbach T, Kesisoglou F, Novakovic J, Tistaert C, Mueller-Zsigmondy M, Kollipara S, Ahmed T, Mitra A, Suarez-Sharp S
Publication: J Pharm Sci
Keywords: bioequivalence, biowaiver, gastroplus, IVIVC, pbbm, PBPK modeling, physiologically based biopharmaceutics modeling, safe space
Software: GastroPlus®

For oral drug products, in vitro dissolution is the most used surrogate of in vivo dissolution and absorption.

Establishing the Bioequivalence Safe Space for Immediate-Release Oral Dosage Forms using Physiologically Based Biopharmaceutics Modeling (PBBM): Case Studies

Establishing the Bioequivalence Safe Space for Immediate-Release Oral Dosage Forms using Physiologically Based Biopharmaceutics Modeling (PBBM): Case Studies

Authors: Heimbach T, Kesisoglou F, Novakovic J, Ahmed T, Mitra A, Suarez-Sharp S
Publication: J Pharm Sci
Keywords: bioavailability, bioequivalence, biopharmaceutics, dissolution model(s), In vitro in vivo correlations (IVIVC), particle size, Physiologically based pharmacokinetic (PBPK) modeling
Software: GastroPlus®
Division: PBPK

For oral drug products, in vitro dissolution is the most used surrogate of in vivo dissolution and absorption.

Integrated Testing Strategy for the Safety of Botanical Ingredients: A Case Study with German Chamomile Constituents

Integrated Testing Strategy for the Safety of Botanical Ingredients: A Case Study with German Chamomile Constituents

Authors: Avonto C, Wang C, Ahn J, Verma RP, Sadrieh N, Dale O, Khan SI, Chittiboyina AG, Khan IA
Publication: Appl In Vitro Tox
Keywords: Alternative methods, chamomilein silico, integrated strategy, skin sensitization
Software: ADMET Predictor®

Introduction: chamomile is a botanical ingredient commonly used in cosmetics, thus determination of skin sensitization effects of German chamomile constituents is critical for the...