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Certara Introduces Simcyp™ Biopharmaceutics Software to Enhance the Efficiency of Novel and Generic Drug Formulation and Development

Wednesday, November 22, 2023

Certara, Inc. (Nasdaq: CERT) has introduced its new Simcyp™ Biopharmaceutics software, designed for use by biopharmaceutic, formulation, and CMC scientists. The software aims to assist in the quick and cost-effective formulation of both novel and generic small molecule medicines. Part of the Simcyp Simulator biosimulation platform, which has played a role in supporting label claims for over 100 approved novel therapies, the Simcyp Biopharmaceutics software extends the platform's applications to earlier stages of drug development.

Certara Scientific Software, highlighted the Simcyp Simulator's reputation in clinical development, including predicting drug-drug interactions, drug-food interactions, and drug performance in diverse populations. Certara has invested in advanced scientific formulation modeling technology and engaged in FDA R&D grant programs over the past five years to address client needs and regulatory requirements in the early phases of drug development.

The Simcyp Biopharmaceutics software aids sponsors in generating evidence for biowaivers, offering an alternative to traditional clinical studies. It is available as a standalone product, catering to life sciences companies of all sizes and aiming to optimize therapy formulations for improved safety, efficacy, and patient convenience.

Key features and benefits of Simcyp Biopharmaceutics software include:

  • Replacing Costly Clinical Bioequivalence Studies: The software incorporates a Virtual Bioequivalence (VBE) module that uses physiologically based pharmacokinetic (PBPK) modeling to demonstrate bioequivalence (BE) between test and reference drugs. This facilitates the attainment of biowaivers, aligning with regulatory encouragement for virtual bioequivalence studies.                                        
  • Optimizing Formulation for Complex Drugs: Addressing challenges posed by Biopharmaceutical Classification System (BCS) Class II-IV drugs, which often exhibit poor solubility and/or absorption, the software aids in the development of oral formulations for these complex drugs, accounting for 90% of new drug candidates.                                                                                                                                          
  • Informing Drug Labels: Recognizing the significance of physiologically based pharmacokinetic (PBPK) models, the FDA acknowledges their role in identifying and optimizing the impact of gastrointestinal effects. Simcyp Biopharmaceutics software enhances these capabilities, enabling the optimization of dosing strategies and providing valuable label guidance to clinicians.



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