This workshop report summarizes the proceedings of Day 2 of a three-day workshop on “ Current State and Future Expectations of...

Patient-centric design for peptide delivery: Trends in routes of administration and advancement in drug delivery technologies
Utilizing peptides as therapeutic agents is considered an attractive approach for the treatment of various diseases due to their high...

Computational Modeling and Pharmacokinetics/ADMET Study of Some Arylpiperazine Derivatives as Novel Antipsychotic Agents Targeting Depression
This study focuses on Quantitative structure–activity relationship (QSAR) and in silico pharmacokinetics/ADMET predictions to investigate the structural...

Population Pharmacokinetic Analysis of Quizartinib in Healthy Volunteers and Patients With Relapsed/Refractory Acute Myeloid Leukemia.
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
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
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
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
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
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 capacity of α-mangostin (α-MG) and β-mangostin (β-MG) from mangosteen pericarp on P-glycoprotein (Pgp) in silico, in vitro...

Proving the Mode of Action of Phytotoxic Phytochemicals
Knowledge of the mode of action of an allelochemical can be valuable for several reasons, such as proving and...

Computational evaluation of endocrine activity of biocidal active substances
Exposure to endocrine disrupting chemicals is an important public health concern although only a few endocrine disruption chemicals have been identified so far.

A Latent Variable Approach to Account for Correlated Inputs in Global Sensitivity
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
In pharmaceutical research and development decision-making related to drug candidate selection...

BCS Class IV Oral Drugs and Absorption Windows: Regional-Dependent Intestinal Permeability of Furosemide
Biopharmaceutical classification system (BCS) class IV drugs (low-solubility low-permeability) are generally poor drug candidates, yet...

5-Fluorouracil Loaded Biogenic and Albumin Capped Gold Nanoparticles Using Bacterial Enzyme—In Vitro-In Silico Gastroplus® Simulation and Prediction
The study investigated in situ biosynthesis of albumin capped 5-fluorouracil (5-FU) loaded gold nanoparticles (NPs) using bacterial extract for enhanced...

Circulating tumor DNA analysis of metastatic renal cell carcinoma
The genomic landscape of metastatic renal cell carcinoma (RCC) is not well understood, and currently available data suggest that it is functionally distinct from that of localized...

Ocular Physiologically Based Pharmacokinetic Modeling for Ointment Formulations
The purpose of this study is to show how the Ocular Compartmental Absorption & Transit (OCAT™) model in GastroPlus® can be used to characterize ocular...

Public Workshop Summary Report on Fiscal Year 2021 Generic Drug Regulatory Science Initiatives: Data Analysis and Model‐Based Bioequivalence
On May 4, 2020, the US Food and Drug Administration (FDA) hosted an online public workshop titled “FY 2020 Generic Drug Regulatory Science...

In vitro investigation of metabolic fate of α-mangostin and gartanin via skin permeation by LC-MS/MS and in silico evaluation of the metabolites by ADMET predictor™
Mangosteen, Garciniam angostana L., is a juicy fruit commonly found in Thailand.