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.
April 2021 News/Events
As they say, April showers bring May flowers...
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.
A Phase 1b Study of Oral Chk1 Inhibitor LY2880070 as Monotherapy in Patients with Advanced or Metastatic Cancer
In the context of DNA damage, Checkpoint Kinase 1 (Chk1) mediates a checkpoint response which arrests the cell cycle and allows the cell to complete DNA repair and replication.
Simulations Plus Sets Date for Second Quarter Fiscal Year 2021 Earnings Release and Conference Call
Conference call to be on Monday, April 12, 2021, at 4:15 p.m. ET
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.
The Future of Clinically Relevant Dissolution Testing and Physiologically Based Biopharmaceutics Modeling (PBBM/PBPK) in Drug Product Development, Manufacturing Changes and Controls
Regulatory applications of dissolution testing as per published FDA guidance...
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...
AAPS Webinar: Translating manufacturing variants from in vitro to the clinic. Opportunities and gaps for IR formulations with additional IVIVC ‘Safe Space’ applications
Development of an in vitro/in vivo correlation (IVIVC) can be most challenging for immediate release (IR) products
Simulations Plus Forms Scientific Advisory Board for RENAsym Consortium
RENAsym SAB to Provide Insights and Guidance for Development of Kidney Injury Software
March 2021 News/Events
2021 SLP MIDD+ Scientific Conference Wrap Up Report
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.