多くの患者にとってこのような利点があるにもかかわらず、新法はすでに希少疾病患者のための新薬の発見と開発に影響を及ぼしています。Not only are drugs that could treat more than one disease being disincentivized, small molecule medicines, which play an important role in treating neurological disorders, cancers, and other diseases, may … Continued
Characterising the small intestine absorptive membrane is essential to enable prediction of the systemic exposure of oral formulations. In particular, the ontogeny of key intestinal Drug Metabolising Enzymes and Transporter (DMET) proteins involved in drug disposition needs to be elucidated to allow for accurate prediction of the PK profile of drugs in the paediatric cohort. … Continued
As part of a collaboration between Medicines for Malaria Venture (MMV), Certara UK and Monash University, physiologically-based pharmacokinetic (PBPK) models were developed for 20 antimalarials, using data obtained from standardized in vitro assays and clinical studies within the literature. The models have been applied within antimalarial drug development at MMV for more than 5 years. During … Continued
We present a physiologically based pharmacokinetic (PBPK) model simulating systemic drug concentrations following administration to the human rectum. Rectum physiology is parameterized based on literature data. The model utilizes in vitro release (IVRT) profiles from which drug mass transfer through the rectal fluid and tissue and into the systemic circulation are predicted. Due to a … Continued
While the concept of ‘Virtual Bioequivalence’ (VBE) using a combination of modelling, in vitro tests and integration of pre-existing data on systems and drugs is growing from its infancy, building confidence on VBE outcomes requires demonstration of its ability not only in predicting formulation-dependent systemic exposure but also the expected degree of population variability. The concept of … Continued
Madin–Darby canine kidney (MDCK) cells are widely used to study epithelial cell functionality. Their low endogenous drug transporter protein levels make them an amenable system to investigate transepithelial permeation and drug transporter protein activity after their transfection. MDCK cells display diverse phenotypic traits, and as such, laboratory-to-laboratory variability in drug permeability assessments is observed. Consequently, … Continued
By: Justin Hay & Frank Engler Pandemics amplify existing strengths and vulnerabilities—not only highlighting who are among the at-risk populations in our society, but also bringing to prominence strengths and weaknesses within healthcare systems and drug development processes. Advancements in vaccines and antivirals were carried out at unprecedented speed during the COVID-19 pandemic using exciting, … Continued
In an interview with HCPLive, Maximilian Vargas, PhD, MBA, vice president of the United States (US) Access Strategy and Account Management within Certara’s Evidence and Access Group, discussed the Inflation Reduction Act (IRA) and what the means for creating a more positive market and treatment environment for biosimilars.
2023 guidance from FDA on dosages in oncology provides further context on expectations with Project Optimus. Reprinted with permission from Applied Clinical Trials. Applied Clinical Trials is a copyrighted publication of MultiMedia Healthcare, LLC. 無断複写・転載を禁じます
This paper introduces external control studies and provides an overview of the key methodological issues to be considered in the design of these studies. A series of case studies are presented in which evidence derived from one or more external controls was submitted to regulatory and HTA agencies to provide support for the consistency of … Continued
