Population Pharmacokinetic Analysis of Quizartinib in Healthy Volunteers and Patients With Relapsed/Refractory Acute Myeloid Leukemia.

Population Pharmacokinetic Analysis of Quizartinib in Healthy Volunteers and Patients With Relapsed/Refractory Acute Myeloid Leukemia.

Authors: Kang D, Ludwig EA, Jaworowicz DJ, Huang H, Fiedler-Kelly J, Cortes J, Ganguly S, Khaled S, Krämer A, Levis M, Martinelli G, Perl A, Russell N, Abutarif M, Choi Y, Mendell J, Yin O
Publication: J Clin Pharmacol
Keywords: AC886, acute myeloid leukemia, population pharmacokinetics, QuANTUM-R, Quizartinib, relapsed/refractory
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Quizartinib is an FMS-like tyrosine kinase 3 (FLT3) inhibitor that has shown robust clinical activity in patients with FLT3-internal tandem duplication-mutated relapsed/refractory acute myeloid leukemia (AML).

Cumulative Fraction of Response for Once- and Twice-Daily Delamanid in Patients with Pulmonary Multidrug-Resistant Tuberculosis

Cumulative Fraction of Response for Once- and Twice-Daily Delamanid in Patients with Pulmonary Multidrug-Resistant Tuberculosis

Authors: Mallikaarjun S, Chapagain ML, Sasaki T, Hariguchi N, Deshpande D, Srivastava S, Berg A, Hirota K, Inoue Y, Matsumoto M, Hafkin J, Geiter L, Wang X, Gumbo T, Liu Y
Publication: Antimicrob Agents Chemother
Keywords: Mycobacterium tuberculosis; PK-PD index; PK-PD target; cumulative fraction of response; delamanid; hollow-fiber system model of tuberculosis
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Pharmacokinetic (PK) and pharmacodynamic (PD) analyses were conducted to determine the cumulative fraction of response (CFR) for 100 mg twice-daily (BID)

Reliance: a smarter way of regulating medical products – The IPRP survey

Reliance: a smarter way of regulating medical products – The IPRP survey

Authors: Doerr P, Valentin M, Nakashima N, Orphanos N, Santos GML, Balkamos G, Saint-Raymond A
Publication: Expert Rev Clin Pharmacol
Keywords: good regulatory practices, regulatory affairs, WHO
Division: PBPK

A survey was conducted among national regulatory authorities' members of the International Pharmaceutical Regulators Programme (IPRP) to collect and share experiences of reliance approaches.

Effect of QTC-4-MeOBnE Treatment on Memory, Neurodegeneration, and Neurogenesis in a Streptozotocin-Induced Mouse Model of Alzheimer’s Disease

Effect of QTC-4-MeOBnE Treatment on Memory, Neurodegeneration, and Neurogenesis in a Streptozotocin-Induced Mouse Model of Alzheimer’s Disease

Authors: Fronza MG, Baldinotti R, Sacramento M, Gutierres J, Carvalho FB, Fernandes MDC, Sousa FSS, Seixas FK, Collares T, Alves D, Pratico D, Savegnago L
Publication: ACS Chem Neurosci
Keywords: alzheimer's disease, central nervous system, Circuits, Nervous system diseases, Peptides and proteins, Rodent models
Software: ADMET Predictor®

Growing evidence suggests that drugs targeting neurogenesis and myelinization could be novel therapeutic targets against Alzheimer’s disease (AD).

Modulating target engagement of small molecules via drug delivery: approaches and applications in drug discovery and development

Modulating target engagement of small molecules via drug delivery: approaches and applications in drug discovery and development

Authors: Yang W, Bhattachar SN, Patel PJ, Landis M, Patel D, Reid DL, Duvnjak Romic M
Publication: Drug Discov Today
Keywords: biopharmaceutics, gastroplus, mechanistic absorption, pbbm, PBPK modeling, physiologically based pharmacokinetics
Software: GastroPlus®

Drug-delivery technologies for modified drug release have been in existence for decades, but their utilization has been largely limited..

Insights of Tris(2-pyridylmethyl)amine as anti-tumor agent for osteosarcoma: experimental and in silico studies

Insights of Tris(2-pyridylmethyl)amine as anti-tumor agent for osteosarcoma: experimental and in silico studies

Authors: Palmeira-Mello MV, Souza JL, Perez AF, Cavalcanti ADS, Kahn SA, Passe-Coutrin N, Guerra IR, Souza AMTDE, Lanznaster M, Cebrián-Torrejón G
Publication: Journal of Molecular Structure
Keywords: admet predictor, in silico, osteosarcoma, pyridylmethyl
Software: ADMET Predictor®

Osteosarcoma (OS) is a malignant bone tumor and its occurrence is associated with high levels of microRNAs (miRNAs) and critical protein involved on intracellular signaling pathways.

The Intestinal Efflux Transporter Inhibition Activity of Xanthones from Mangosteen Pericarp: An In Silico, In Vitro and Ex Vivo Approach

The Intestinal Efflux Transporter Inhibition Activity of Xanthones from Mangosteen Pericarp: An In Silico, In Vitro and Ex Vivo Approach

Authors: Dechwongya P, Limpisood S, Boonnak N, Mangmool S, Takeda-Morishita M, Kulsirirat T, Rukthong P, Sathirakul K
Publication: Molecules
Keywords: bidirectional transport, Caco-2 cells, ex vivo absorptive transport, mangosteen pericarp, MDR1 expression, P-glycoprotein, xanthones
Software: ADMET Predictor®

The capacity of α-mangostin (α-MG) and β-mangostin (β-MG) from mangosteen pericarp on P-glycoprotein (Pgp) in silico, in vitro...

Computational evaluation of endocrine activity of biocidal active substances

Computational evaluation of endocrine activity of biocidal active substances

Authors: Stanojević M, Grobelšek MV, Dolenc MS
Publication: Chemosphere
Keywords: Biocides, Endocrine disruption, in silico methods, molecular docking, Nuclear receptors, QSAR
Software: ADMET Predictor®

Exposure to endocrine disrupting chemicals is an important public health concern although only a few endocrine disruption chemicals have been identified so far.

Secure your 2021 Model Informed Drug Development (MIDD), PBPK or PBBM goals – Use your 2020 year-end budget today!
  • Blog

Secure your 2021 Model Informed Drug Development (MIDD), PBPK or PBBM goals – Use your 2020 year-end budget today!

Authors: Padron A
Keywords: DDIs, exclusive offer, MIDD, MIDD (model-informed drug development), PBPK modeling
Software: GastroPlus®
Division: PBPK

In 2021, we are committed to expanding our collaborations to advance the science of drug development, reduce the time and cost of research, and improve patient wellness. With this commitment, we are extending an exclusive offer for training and regulatory advice and support at 2020 rates for use next year.

Population pharmacokinetics of MYL-1401O (a trastuzumab biosimilar) and reference trastuzumab (Herceptin®) in patients with HER2-positive metastatic breast cancer

Population pharmacokinetics of MYL-1401O (a trastuzumab biosimilar) and reference trastuzumab (Herceptin®) in patients with HER2-positive metastatic breast cancer

Authors: Owen JS, Rackley R, Liu M, Fuentes-Alburo A, Idris T, Loganathan S, Barve A, Waller CF, Rugo HS
Conference: San Antonio Breast Cancer Symposium (SABCS)
Keywords: breast cancer, HER2 receptor, MYL-1401O, PopPK, population pharmacokinetics, trastuzumab
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Mylan trastuzumab (MYL-1401O) is a biosimilar to trastuzumab (Herceptin®)

A Latent Variable Approach to Account for Correlated Inputs in Global Sensitivity

A Latent Variable Approach to Account for Correlated Inputs in Global Sensitivity

Authors: Melillo N, Darwich AS
Publication: Cornell University
Keywords: correlated factors, global sensitivity analysis, latent variable, model-informed drug discovery and development, physiologically based pharmacokinetic models, systems modelling
Software: ADMET Predictor®

In pharmaceutical research and development decision-making related to drug candidate selection, efficacy and safety...

A latent variable approach to account for correlated inputs in global sensitivity analysis with cases from pharmacological systems modelling

A latent variable approach to account for correlated inputs in global sensitivity analysis with cases from pharmacological systems modelling

Authors: Melillo N, Darwich AS
Keywords: correlated factors, global sensitivity analysis, latent variable, model-informed drug discovery and development, physiologically based pharmacokinetic models, systems modelling
Software: ADMET Predictor®

In pharmaceutical research and development decision-making related to drug candidate selection...