Predicting Drug Efficacy and Mechanism of Action

At MedPharm, our Disease Activity Models provide preclinical and in vitro platforms to assess topical and transdermal drug formulations’ efficacy, mechanism of action, and therapeutic potential. We utilize customized in vitro models to assist pharmaceutical companies in simulating disease conditions, optimizing formulations, and generating regulatory-compliant data for IND, NDA, and ANDA submissions. 

Our scientifically validated models facilitate early-stage drug screening, biomarker identification, and a mechanistic understanding of formulations targeted for dermatological, inflammatory, and infectious diseases.  

Key Components of Disease Activity Models  

Custom In Vitro Models for Disease-Specific Applications: 

• Advanced models for inflammatory, infectious, and dermatological conditions 

• Reconstructed human skin models that mimic real-world disease environments 

• 3D tissue cultures to assess drug penetration, metabolism, and activity 

• Pathogen-host interaction models for antimicrobial and antifungal testing 

Mechanism of Action & Biomarker Analysis: 

• Assessment of cytokine and inflammatory marker expression 

• Evaluation of cellular and molecular responses to active pharmaceutical ingredients (APIs) 

• Gene expression profiling to identify targeted therapeutic effects 

• Immunological response evaluation for immune-modulating formulations 

Drug Efficacy & Permeation Testing: 

• In vitro permeation testing (IVPT) to evaluate drug absorption through diseased skin 

• In vitro release testing (IVRT) to measure drug dissolution and delivery kinetics 

• Customized disease-state permeability studies to optimize formulation development 

• Screening of excipients, penetration enhancers, and delivery systems 

Regulatory & Bioequivalence Study Support: 

• Predictive data to support IND, NDA, ANDA, and 505(b)(2) submissions 

• Regulatory-compliant disease models for preclinical and bioequivalence studies 

• Risk mitigation strategies for formulation modifications and therapeutic targeting 

• Comprehensive regulatory documentation to ensure data integrity and approval readiness 

Why Choose MedPharm for Disease Activity Models? 

• Industry-leading expertise in in vitro disease modeling and drug development 

• Regulatory-Compliant Preclinical and Mechanistic Testing for IND and NDA filings 

• Custom Disease Models for dermatological, inflammatory, and infectious conditions 

• Seamless Integration with formulation development and bioanalytical testing 

• State-of-the-art laboratories supporting early-stage drug screening and validation 

Optimize Drug Development with MedPharm’s Disease Activity Models

MedPharm optimizes your topical and transdermal drug formulations for therapeutic efficacy, regulatory compliance, and market success using validated in vitro disease models, predictive biomarker analysis, and advanced permeation testing.