Ultraviolet exposure can cause photoaging toward the human skin which is begun by the inflammation on the exposure area, also resulting in activation of a degradative enzyme cathepsin L.
Basic of machine learning and deep learning in imaging for medical physicists
The manuscript aims at providing an overview of the published algorithms/automation tool for artificial intelligence applied to imaging for Healthcare.
PK/PD modeling of a clazosentan thorough QT study with hysteresis in concentration-QT and RR-QT
Clazosentan's potential QT liability was investigated in a thorough QT study in which clazosentan was administered intravenously as a continuous infusion of 20 mg/h immediately followed by 60 mg/h.
Prediction of fraction unbound in plasma in children in data-limited scenarios for human health risk assessment
In human health risk assessment, pediatric physiologically-based pharmacokinetic modeling has been used to predict chemical-specific toxicokinetic adjustment factors.
The emerging plasticity of SARS-CoV-2
Viruses evolve as a result of mutation (misincorporations, insertions or deletions, and recombination) and natural selection for favorable traits such as more efficient viral replication, transmission, and evasion of host defenses.
Characterization of stress degradation products of nintedanib by UPLC, UHPLC-Q-TOF/MS/MS and NMR: Evidence of a degradation product with a structure alert for mutagenicity
Nintedanib is an anti-cancer drug used for the treatment of idiopathic pulmonary fibrosis and non-small cell lung cancer.
Experimental Solubility, Thermodynamic/Computational Validations, and GastroPlus-Based In Silico Prediction for Subcutaneous Delivery of Rifampicin
We focused to explore a suitable solvent for rifampicin (RIF) recommended for subcutaneous (sub-Q) delivery [ethylene glycol (EG), propylene glycol...
Extemporaneous Compounding and Physiological Modeling of Amlodipine/Valsartan Suspension
In case of absent liquid dosage form, crushing a tablet or dispersing a capsule would be the most convenient option for using these drugs in patients with dysphagia difficulties.
Next generation risk assessment of human exposure to anti-androgens using newly defined comparator compound values
Next Generation Risk Assessment (NGRA) can use the so-called Dietary Comparator Ratio (DCR) to evaluate the safety of a defined exposure...
In vitro and in vivo correlation for lipid-based formulations: Current status and future perspectives
Lipid-based formulations (LBFs) have demonstrated a great potential in enhancing the oral absorption of poorly water-soluble drugs.
A comprehensive review of integrative pharmacology-based investigation: A paradigm shift in traditional Chinese medicine
Over the past decade, traditional Chinese medicine (TCM) has widely embraced systems biology and its various data integration approaches to promote its modernization.
Relationship of the Calcitonin Gene-Related Peptide Monoclonal Antibody Galcanezumab Pharmacokinetics and Capsaicin-Induced Dermal Blood Flow in Healthy Subjects
Galcanezumab, a humanized monoclonal antibody targeting calcitonin gene-related peptide, was recently approved for...
A Survey of the Regulatory Requirements for the Waiver of In Vivo Bioequivalence Studies of Generic Products in Certain Dosage Forms by Participating Regulators and Organisations of the International Pharmaceutical Regulators Programme
The requirements to waive in vivo bioequivalence studies for immediate release solid oral dosage forms based on the Biopharmaceutics Classifications System (BCS) are well known, and biowaivers[1] for other types of oral dosage forms based on pre-defined criteria may also be acceptable.
Physiologically Based Biopharmaceutics Modeling of Regional and Colon Absorption in Dogs
Colon absorption is a key determinant for the successful development of modified-release (MR) formulations, and the risk that colon absorption may limit the in vivo performance...
An IPRP survey of the regulatory requirements for the waiver of in vivo bioequivalence studies of generic medicinal products in certain dosage forms
The requirements to waive in vivo bioequivalence studies for immediate release solid oraldosage forms based on the Biopharmaceutics Classifications System (BCS) are well known, and biowaiversafor other types of oral dosage forms based on pre-defined criteria may also be acceptable.
Retrospective Analysis Using Pharmacokinetic/Pharmacodynamic Modeling and Simulation Offers Improvements in Efficiency of the Design of Volunteer Infection Studies for Antimalarial Drug Development
Volunteer infection studies using the induced blood stage malaria (IBSM) model have been shown to facilitate antimalarial...
Neutralization of European, South African, and United States SARS-CoV-2 mutants by a human antibody and antibody domains
Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) transmission with several emerging variants remain uncontrolled in many countries, indicating the pandemic remains severe.
Leveraging Oral Drug Development to a Next Level: Impact of the IMI-Funded OrBiTo Project on Patient Healthcare
A thorough understanding of the behavior of drug formulations in the human gastrointestinal (GI) tract is essential when working in the field of oral drug development in a pharmaceutical company.
Prediction of Plasma Concentrations Using In Silico Modeling and Simulation Approach: Case of Acebutolol
The aim of this study was to predict the plasma concentrations of acebutolol tablets with different dissolution profiles using computer modelling and evaluating whether they are bioequivalent using simulated population studies.
Deposition of pentamidine analogues in the human body – spectroscopic and computational approaches
Bis-benzamidines are a diverse group of compounds with high potential in pharmacotherapy, and among them, pentamidine is a drug of great...