Tag: Simcyp
Simcyp：20年に渡るイノベーションの軌跡
Simcyp Timeline: 20年に渡るイノベーションの軌跡
SIVA V3: Simcyp in Vitro Analysis Toolkit
The SIVA Toolkit is a user-friendly platform, specifically designed to assist scientists
with the analysis of complex in vitro studies using whole cells, tissue samples, and solid
dosage forms to assess the exposure, metabolism, transport, and dissolution/solubility
of drugs.
Certara Launches New Version of Simcyp® Simulator for Population-Based Pharmacokinetic Modeling and Simulation
Version 19 offers mechanistic models for assessing maternal-fetal drug risk, developing drug formulations, and optimizing dermal and transdermal drug development
Certara’s Simcyp Division Acquires Modeling and Simulation Platform for Neurodegenerative Diseases from In Silico Biosciences, Inc.
PRINCETON, NJ – Feb. 25, 2020 – Certara’s Simcyp Division Acquires Modeling and Simulation Platform for Neurodegenerative Diseases from In Silico Biosciences, Inc. Acquisition will spur the development of new drugs to treat complex neurodegenerative conditions, including Alzheimer’s and Parkinson’s disease.
Certara’s Simcyp MechDermA Model Achieves Regulatory Approval: Demonstrates Virtual Bioequivalence in Dermal Drug Development
Demonstrating bioequivalence (BE) remains the key regulatory hurdle for generic drug approval. However, this is a challenging process for today’s complex drugs and alternative delivery methods. Consequently, patients lack availability of thousands of generics. This problem is especially vexing for topical drugs and trans-dermal patches. Regulatory Support for Expediting the Development of Dermal Generics The … Continued
How to Demonstrate Virtual Bioequivalence for Complex Dermal Generic Drugs
This webinar will explain how Certara expanded its PBPK Simcyp Simulator to incorporate an extensive dermal model— MPML MechDermA, a multi-phase, multi-dimensional dermal absorption model.
Certaraは、Galderma社とのパートナーシップの下、局所アクネクリームであるAKLIEF®の米国FDA承認を取得
PRINCETON, NJ – Jan. 8, 2020 – Certara’s Simcyp® Simulator’s MechDermA™ model provided safety label claim and pediatric dosing information without the need for testing in clinical patients for a topical drug product.
Updates to the Simcyp Simulator’s Oral Absorption ADAM and M-ADAM Models
This webinar provided an update on the extensive recent additions to the mechanistic models for handling oral dosage forms available within the ADAM/M-ADAM framework.
