Drug development for rare diseases is challenged by small populations and limited data.
Policy on Disclosure and Management of Financial Conflicts of Interest related to Public Health Service Research
Policy for disclosure & management of financial conflicts of interest related to PHS Research, with an issue date of the Notice of Award on or after August 24, 2012.
PMDA Adds Licenses of GastroPlus®
Japanese government organization to train reviewers to efficiently analyze PBPK model submissions
Application of Mechanistic Ocular Absorption Modeling and Simulation to Understand the Impact of Formulation Properties on Ophthalmic Bioavailability in Rabbits: a Case Study Using Dexamethasone Suspension
Developing mathematical models to predict changes in ocular bioavailability and pharmacokinetics due to differences in the physicochemical properties of complex topical ophthalmic suspension formulations...
The Biopharmaceutics Classification System (BCS) and the Biopharmaceutics Drug Disposition Classification System (BDDCS): Beyond guidelines
The recent impact of the Biopharmaceutics Classification System (BCS) and the Biopharmaceutics Drug Disposition Classification System (BDDCS) on relevant scientific advancements is discussed.
U.S. FDA Renews DILIsym Software Licenses
U.S. FDA Remains Committed to Streamline & Accelerate Drug Development using Model-Informed Drug Development (MIDD) technology
How to obtain biowaivers for clinical trials using PBPK models, two case studies
FDA is open to proposals of using modeling approaches for bioequivalence (BE), or for new drugs,with the proper justification and model verification
Advancing current PBPK model applications to support internal development and regulatory decisions
Numbers of applications (NDA, ANDA) supported by PBPK modeling has increased significantly since 2008.
Physiologically Based Pharmacokinetic Modeling to Evaluate Formulation Factors Influencing Bioequivalence of Metoprolol Extended‐Release Products
The University of Florida Center for Pharmacometrics and Systems Pharmacology and the Food and Drug Administration Office of Generic Drugs have collaborated on a research project to develop...
Evaluating the Clinical Impact of Formulation Variability: A Metoprolol Extended‐Release Case Study
The objective of this research was to evaluate the impact of changes in the formulation of metoprolol extended‐release (ER) tablets on dissolution, pharmacokinetic, and exercise‐induced heart rate (EIHR) using...
Simulations Plus to Present at B. Riley FBR Investor Conference on May 22, 2019
Shawn O’Connor, chief executive officer, will present at the 20th Annual B. Riley FBR Institutional Investor Conference on Wednesday, May 22, at 10:30 a.m. (PDT) in Room 8.
Oxysterols and apolipoproteins in multiple sclerosis: a 5-year follow-up study
The purpose of this work was to investigate whether changes in oxysterol and apolipoprotein levels over 5 years are associated with...
Discovery of Membrane Permeability, Pharmacokinetics Properties and Mechanism of Action for Analogs of Ethylenediamine-N,N′-di-2-(3-Cyclohexyl)Propionic Acid and 1,3-Propandiamine-N,N′-di-2-(3-Cyclohexyl)Propionic Acid with Antiproliferative Activity Using In Vitro and In Silico Methods
In previously in vitro studies on different cell lines and in vivo on melanoma and 4T1 murine breast cancer and metastasis it was shown antiproliferative activity for ester derivatives of (S,S)-ethylenediamine-N,N′-di-2-(3-cyclohexyl)propanoic acid, and (S,S)-1,3-propanediamine-N,N′-di-2-(3-cyclohexyl)propanoic acid.
Androgen Receptor and PI3K Pathway Activity in Ovarian Cancer
We sought to evaluate androgen receptor (AR) and PI3K pathway activity in ovarian cancer cell lines and tissue and determine if either pathway was correlated with growth...
Development of a Direct CD8+ T Cell Activation QSP Model for Ovalbumin in the Context of Liver Injury Advances Groundwork for Mathematical Representation of Idiosyncratic Drug-Induced Liver Injury (iDILI)
Extensive progress has been made in identifying mechanisms for dose-dependent drug-induced liver injury (DILI) and in developing screening assays to reduce its incidence.
In Silico and in Vitro Simulations to Predict Idiosyncratic DILI: What is on the Horizon?
Multiple species: human, rat, mouse, and dog, Population variability, The three primary acinar zones of liver represented, Essential cellular processes represented to multiple scales in interacting submodels...
Assessing and Managing DILI Risk in Trials: A Consultant’s Perspective
DILI typically has drug-specific “signatures”: Hepatocellular, cholestatic, mixed (R-value), Latency “window,” Rate of progression, rate of resolution, Extra-hepatic manifestations (e.g. hypersensitivity signs)
Assessing Effects of BHV-0223 40 mg Zydis® Sublingual Formulation and Riluzole 50 mg Oral Tablet on Liver Function Test Parameters Utilizing DILIsym®
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease characterized by the death of motor neurons that leads to progressive muscle weakness and difficulties in speaking, swallowing, and breathing.
In Silico Prediction of Plasma Concentrations of Fluconazole Capsules with Different Dissolution Profiles and Bioequivalence Study Using Population Simulation
A biowaiver is accepted by the Brazilian Health Surveillance Agency (ANVISA) for immediate-release solid oral products containing Biopharmaceutics Classification System (BCS) class I drugs showing rapid drug dissolution.
Minor structural modifications of bisphenol A strongly affect physiological responses of HepG2 cells
Bisphenols represent a large group of structurally similar compounds.