Certara Announces Release of Simcyp™ Simulator Version 21, Expanding Capabilities to Align with Recent Regulatory Guidances
Certara’s Simcyp physiologically-based pharmacokinetic (PBPK) Simulator models describe the behavior of drugs in different body tissues and include genetic, physiological and epidemiological databases that facilitate simulations in virtual populations. The Simcyp Simulator has been used to inform more than 250 label claims for 85+ novel drug approvals by the
“We are excited to offer new capabilities to advance modern drug development with the launch of our latest Simcyp Simulator,” said
New capabilities of the Simcyp Simulator include:
- Updates to renal- and hepatic-impaired population models to align with recent FDA guidance on pharmacokinetics and support dosing and labelling decisions
- Expansion of the human brain model to a five-compartment model, enabling the prediction of drug concentrations in cerebrospinal fluid and interstitial and intracellular brain fluid compartments
- Additions to the compound library to facilitate drug-drug interaction analysis on a wider range of compounds, including progestins in support of the FDA’s recent oral contraception guidance
- Updates to Simcyp Animal to help increase confidence in translating from animals to humans and refine the design of subsequent studies
- Incorporation of 11 new or updated genotype and phenotype frequency and abundance values across several populations to improve gene variant-dependent drug exposure predictions, which can aid decision-making in clinical studies
“The application of Simcyp modeling continues to grow in formulation development, drug-drug interactions and special populations for novel drugs,” said
Version 21 also features updates to Simcyp modules for pediatrics, pregnancy, lactation, biologic drugs, virtual bioequivalence and in vitro-in vivo correlation.
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Source: Certara