PBPK Modeling to Support Bioequivalence & Generic Product Approvals
Physiologically-based pharmacokinetic modeling can be used to support bioequivalence (BE) assessment of complex and locally acting generic drugs.
Tag: Dermatology
Certara’s Simcyp PBPK Achieves First FDA Virtual Bioequivalence Approval for ‘Complex’ Generic Drug
PRINCETON, NJ – June 12, 2019 – Certara’s Simcyp®️ physiologically-based pharmacokinetic (PBPK) modeling and simulation technology was used to demonstrate bioequivalence (BE) for the US Food and Drug Administration (FDA) approval of a complex generic drug on the agency’s abbreviated new drug application (ANDA) pathway.
Multi-phase Multi-layer Mechanistic Physiologically-based Pharmacokinetic Dermal Absorption Model Verification Including Inter- and Intra-individual Variability Assessment Using Nicotine as a Model Drug
Predicting Depth Resolved Concentrations in the Dermis Using PBPK Modeling: Design, Development and Verification of the Model with Five Drugs
Combining Machine Learning and Mechanistic Modeling Approaches to Solve Real Life Problems and Assessment of the Local Tissue Binding and Its Influence on the Systemic Exposure after Topical Application of Drugs
Performance Verification of Mechanistic Dermal Physiological Based Pharmacokinetic (PBPK) Model for Enhanced Understanding of Dermal Absorption: Prediction of Local Tissue Exposure after Topical Application of Acitretin
Immunogenicity Prediction and Dose Optimization using Clinically-Validated In Silico Modeling and Simulation
Biologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Immunogenicity is an inherent challenge with this complex class of drugs. A quantitative systems pharmacology approach can be used to predict and better manage immunogenicity, and as a tool to guide clinical and regulatory decision-making in biologics drug development.
Population Pharmacokinetic Modeling of Tildrakizumab (MK-3222), an Anti-interleukin-23-p19 Monoclonal Antibody, in Healthy Volunteers and Subjects with Psoriasis
A Model-based Meta-analysis (MBMA) to Support Development of Medicines for Treatment of DPN, PHN, and Fibromyalgia
Skin in the Game: Mechanistic Modeling of Dermal Drug Absorption
The ability to estimate systemic exposure from dermal absorption is essential in developing new dermatological medications or assessing the toxicological liability of commercially-used chemicals. Historically, animal models were used to evaluate dermal drug absorption prior to clinical testing. However, both differences in human and animal physiology as well as ethical concerns over animal testing have … Continued