Simcyp™ Biopharmaceutics

Simcyp Biopharmaceutics stands as the latest addition to the prestigious Simcyp family of mechanistic and predictive modeling technologies. Complementing Simcyp Animal, Simcyp Discovery, and the renowned Simcyp Simulator for physiologically based pharmacokinetic (PBPK) modeling, Simcyp Biopharmaceutics brings a new dimension to our suite of solutions.

Delivering substantial value to biopharmaceutics scientists across multiple dimensions Simcyp Biopharmaceutics streamlines the identification and refinement of promising formulations in a cost-effective manner. Furthermore, it offers tailored support for formulation strategies in the dynamic landscape of complex novel and generic drugs. Moreover, Simcyp Biopharmaceutics enhances the achievement of successful biowaivers, ultimately bolstering overall success rates.

Simcyp Biopharmaceutics’ many proven use cases include: 

• • Early formulation development

• • Bio-waiver applications, facilitating formulation or manufacturing site changes

• • Virtual Bioequivalence (VBE) assessments

• • Extended Release (ER) formulation optimization

• • Accelerating 505(b)2 applications for approved drug products

• • Defining in vitro specifications for bioequivalence with marketed formulations (i.e., safe spaces)

• • Development of clinically relevant dissolution specifications

• • Dissolution method development

• • Modeling the impact of salt, polymorph, excipients, prodrugs, and solid dispersions on dissolution and exposure

Unique use cases include: 

• • Virtual Bioequivalence (VBE) – Increasingly encouraged by regulators, VBE leverages PBPK to demonstrate bioequivalence (BE) between test and reference drugs in lieu of clinical studies.  Simcyp Biopharmaceutics includes a VBE module that automates comparison of crossover and parallel trial design and supports simultaneous estimation of both within- and between-subject variability, thus increasing opportunities for attaining biowaivers.

• • BCS Class II, III, IV drugs – The Biopharmaceutical Classification System (BCS) is a tool used for classifying drugs based on dissolution, solubility, and permeability.  Simcyp Biopharmaceutics facilitates the development of Class II-IV BCS Class drugs, which now account for 90% of new drug candidates and present significant formulation challenges, via its unique tools for evaluating particle size distribution, dual solid state drug form handling, and mechanistic surface pH, salt and excipient models.

• • Automated ‘safe space’ identification – Simcyp Biopharmaceutics may be used to optimize and potentially expand the acceptable operating parameters, within which drug batches may be considered to be equivalent, thus increasing manufacturing output and saving unnecessary BE clinical studies for drug manufacturers.

Use Cases

Features and Capabilities

Model-Informed Formulation Development (MIFD), that’s the power of Simcyp Biopharmaceutics

Simcyp Biopharmaceutics delivers value across several areas to identify and/or refine promising formulations faster and cheaper, support formulation strategy for today’s complex novel and generic drugs and increase success in attaining biowaivers.