Failures surrounding pharmaceutical quality, particularly with respect to product manufacturing issues and facility remediation, account for the majority of drug shortages and product recalls in the United States.
Network pharmacology-based identification of key pharmacological pathways of Yin–Huang–Qing–Fei capsule acting on chronic bronchitis
For decades in China, the Yin–Huang–Qing–Fei capsule (YHQFC) has been widely used in the treatment of chronic bronchitis, with good curative effects.
Low Testosterone Alters the Activity of Mouse Prostate Stem Cells
Background: Low serum testosterone (low T) has been repeatedly linked to worse outcomes in men with newly diagnosed prostate cancer (PC). How low T...
Revisiting the SAR of the Antischistosomal Aryl Hydantoin (Ro 13-3978)
The aryl hydantoin 1 (Ro 13-3978) was identified in the early 1980s as a promising antischistosomal lead compound. However, this series of aryl hydantoins produced...
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 – Hybrid LBA/LCMS and input from regulatory agencies)
The 2016 10th Workshop on Recent Issues in Bioanalysis (10th WRIB) took place in Orlando, Florida with participation of close to 700 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide.
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 – LBA, biomarkers and immunogenicity)
The 2016 10th Workshop on Recent Issues in Bioanalysis (10th WRIB) took place in Orlando, Florida with participation of close to 700 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide.
Biodegradation and detoxification of naphthenic acids in oil sands process affected waters
After oil sands process affected water (OSPW) was treated in a continuous flow biofilm reactor, about 40% of the organic compounds in the acid extractable fraction (AEF) including naphthenic acids (NAs)...
Prediction of CNS occupancy of dopamine D2 receptor based on systemic exposure and in vitro experiments.
The effect of drugs in the central nervous system (CNS) is closely related to occupancy of their target receptor.
Extension of the dissolution-precipitation model for kinetic elucidation of solvent-mediated polymorphic transformations
Thorough understanding and control of the different crystal forms of a drug product is key for fine chemistry and materials science; it ultimately determines the product's physicochemical properties and performance.
Incorporating transporter kinetics into PBPK models
This webinar will focus more on transporters involved in drug distribution and elimination. A brief summary of current information on transporter expression levels will be followed by a description of options for including transporters in the GastroPlus™ PBPK model.
Structural and conformational determinants of macrocycle cell permeability
Macrocycles are of increasing interest as chemical probes and drugs for intractable targets like protein-protein interactions, but the determinants of their cell permeability and oral absorption are poorly understood.
Forecasting oral absorption across biopharmaceutics classification system classes with physiologically based pharmacokinetic models
The aim of this study was (1) to determine how closely physiologically based pharmacokinetic (PBPK) models can predict oral bioavailability using a priori knowledge of drug-specific properties and (2) to...
In vitro and in silico investigation of electrospun terbinafine hydrochloride-loaded buccal nanofibrous sheets
Terbinafine hydrochloride-loaded nanofibrous buccal films were formulated with the aim to improve the solubility and dissolution behavior; thus, the local effectiveness of the antifungal agent.
Vitamin K epoxide reductase expression and prostate cancer risk
Purpose: Increasing evidence has demonstrated that men taking the anticoagulant warfarin have a lower risk of developing prostate cancer. This phenomenon is not observed...
An in vitro and in silico study of the impact of engineered surface modifications on drug detachment from model carriers
In silico modeling was used to predict the impact of carrier surface modifications on the in vivo plasma concentration of an active pharmaceutical ingredient (API) and as a tool to support formulation development.
Development of Physiologically Based Pharmacokinetic (PBPK) Model for Simulating the Disposition of Antibody Drug Conjugates
Antibody- drug conjugates (ADCs) are a novel class of therapeutic agents that deliver potentcy totoxic drug molecules (payload) to their targets while reducing systemic exposure. ADCs may be composed of...
Simulation of in vitro Caco-2 Papp from Molecular Structure Estimation of Intracellular Km for Efflux Transporters
To build in silico models based on molecular structure that estimate the rate of passive diffusion into and out of the cell membrane and to combine those estimates with a cellular simulation of Caco-2...
Modeling of Cilostazol absorption and pharmacokinetics in Beagle Dogs and design of in-vitro dissolution experiment to model the in-vivo absorption
The purpose of this study was to evaluate the in-vitro/in-vivo (IVIV) correlationfor a Class II compound and to design an in-vitro dissolution experiment that improves this IVIV correlation by taking...