Understanding Drug Distribution and Bioavailability

At MedPharm, our Tissue Protein Binding Models provide essential insights into drug distribution, retention, and release within biological tissues. This information helps pharmaceutical companies optimize formulation strategies, enhance drug bioavailability, and meet regulatory requirements. By assessing how topical and transdermal drug formulations interact with tissue proteins, we support predictions of drug efficacy, pharmacokinetic (PK) modeling, and bioequivalence studies.  

Using state-of-the-art bioanalytical techniques and regulatory-compliant methodologies, we generate high-quality data for formulation refinement, clinical trial planning, and regulatory submissions (IND, NDA, ANDA). 

Key Components of Tissue Protein Binding Models

Assessment of Drug-Tissue Interactions 

• Quantification of free vs. bound drug concentrations in skin, mucosa, and soft tissues 

• Evaluation of drug retention and release from tissue reservoirs 

• Analysis of API-protein interactions that affect drug bioavailability 

• Prediction of drug clearance, distribution, and systemic absorption 

Optimizing Drug Absorption and Release Profiles 

• Determination of protein-binding kinetics to enhance formulation effectiveness 

• Comparison of formulation variations to optimize drug release 

• Analysis of penetration enhancers and excipients that affect tissue retention 

• Custom binding models for specific disease applications 

Bioanalytical Testing for Pharmacokinetics and Bioequivalence 

• Assessment of API absorption, metabolism, and distribution in tissues 

• Tissue extraction and drug quantification using LC-MS/MS and HPLC 

• Support for PK modeling and bioequivalence (BE) studies 

• Correlation of tissue-binding results with systemic exposure data

Regulatory and Data Integrity Compliance 

• ICH-compliant tissue protein binding studies for regulatory submissions 

• CMC (Chemistry, Manufacturing & Controls) documentation for IND, NDA, and ANDA filings 

• Compliance with FDA 21 CFR Part 11 for data integrity and electronic records 

• Regulatory support for bioequivalence and biowaiver studies 

Why Choose MedPharm for Tissue Protein Binding Models? 

• Industry-leading expertise in drug-tissue interaction studies 

• Regulatory-compliant testing for IND, NDA, and ANDA submissions 

• Advanced bioanalytical techniques for pharmacokinetic and bioequivalence support 

• Seamless integration with formulation development and in vitro testing 

• GMP and GLP-certified laboratories supporting both early-stage and late-stage development 

Optimize Drug Absorption and Distribution with MedPharm’s Tissue Protein Binding Models

With scientifically validated tissue-binding assays, bioanalytical expertise, and regulatory-driven data generation, MedPharm ensures that your topical and transdermal drug formulations achieve optimal bioavailability, efficacy, and regulatory success.