Business Wire

Certara’s Simcyp PBPK Modeling and Simulation Technology Achieves First FDA Virtual Bioequivalence Approval for ‘Complex’ Generic Drug

PRINCETON, N.J.--(BUSINESS WIRE)--Certara ® the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced that its Simcyp ® ...
NJBIZ

Certara celebrates 20th anniversary of Simcyp Consortium

Princeton-based Certara, a model-informed drug development and decision support company, announced Wednesday it is celebrating the 20th anniversary of its Simcyp Consortium. According to Certara, the ...
Yahoo Finance

Certara introduces Simcyp™ Biopharmaceutics software to increase efficiency of novel and generic drug formulation & development

PRINCETON, N.J., Nov. 21, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the introduction of Simcyp™ Biopharmaceutics software. It is designed ...
Seeking Alpha

Certara announces the release of Simcyp™ PBPK Simulator Version 22, expanding ability to simulate untested scenarios for new patient and therapeutic types

PRINCETON, N.J., March 07, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (CERT), a global leader in biosimulation, today announced the release of Simcyp Simulator Version 22, which includes new capabilities ...
Seeking Alpha

Certara Simcyp™ Group Awarded Two New Grants from US FDA

PRINCETON, N.J., Aug. 29, 2023 (GLOBE NEWSWIRE) -- Certara (CERT), a global leader in biosimulation, today announced that the Simcyp group has been awarded two new grants from the U.S. Food and Drug ...
Odessa American

Certara Releases Simcyp™ PBPK Simulator Version 20, Including Newly Expanded Biologics Software

Certara, Inc., the global leader in biosimulation, today announced the release of version 20 of its Simcyp™ Physiologically-based Pharmacokinetic (PBPK) Simulator platform. Simcyp PBPK Simulator ...
Nasdaq

Certara Awarded FDA Grant to Further Advance Virtual Bioequivalence Assessments of Generic Medicines Using Biosimulation

PRINCETON, N.J., Sept. 20, 2021 (GLOBE NEWSWIRE) -- Certara (Nasdaq: CERT), a global leader in biosimulation, today announced the Company has been awarded a grant from the U.S. Food and Drug ...
Business Wire

US FDA Awards Certara’s Simcyp Division Two New Dermal Virtual Bioequivalence Grants

PRINCETON, N.J.--(BUSINESS WIRE)--Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access, today announced that it has been awarded ...
Mena FN

Bioequivalence Studies Market To Hit US$ 1349.06 Million By 2033, North America Led 43.5% Of Global Market Share.

(MENAFN- EIN Presswire) EINPresswire/ -- The global Bioequivalence Studies Market size was US$ 701.70 Million in 2024 and is expected to reach US$ 1349.06 Million by 2033, growing at a CAGR of 7.5% ...
Healthcare Dive

Certara’s Simcyp PBPK Modeling and Simulation Technology Achieves First FDA Virtual Bioequivalence Approval for ‘Complex’ Generic Drug

In-silico bioequivalence approach using Simcyp’s Multi-Phase Multi-Layer Mechanistic Dermal Absorption model successfully replaced in-vivo, clinical studies in FDA ANDA approval PRINCETON, NJ – June ...