Helping clients achieve effective and efficient drug development and clinical

pharmacology programs using model informed drug development



  • Streamline drug development by improving the efficiency of the Pre-IND phase to the Proof-of-Concept study


  • Strategic drug development planning, specifically in clinical pharmacology plans




  • Maximize information - the right data at the right time


  • Make timely data-driven decisions


  • Minimize waste - plans and studies designed to target specific program, business and regulatory goals while avoiding superfluous studies or assessments




  • Partners with experts possessing a broad range of experience from other disciplines to optimize strategies and study designs


  • Meets project goals and development objectives through an expansive, reliable approach





  • Standard non-compartment PK analysis for non-clinical and human PK/PD studies


  • Phase 1 study designs and dose selection for first-in-human, multiple dose tolerance, drug-drug interaction, dose response, and proof of concept studies


  • In-licensing opportunity preparation and evaluation - experience in first-pass review and full due diligence of the pharmacokinetic and clinical pharmacology aspects of drug candidates




  • IND option selection for streamlining development and decision making


  • Phase 1 study design option selection to maximize information and minimizing cost


  • Proof of concept study design optimization to enhance learning and decision making


  • Develop quantitative decision making criteria through comparison of marketing profile to market place competition




  • Development plans, study designs and analysis based on:


- the body of drug and disease state literature


- the understanding of PK, dose-response, disease progression, and time course of drug effect.


  • PK/PD and dose-response analysis


  • Phase 2/3 population PK and PK/PD study design and analysis




Print | Sitemap
Copyright © 2018. Milad Pharmaceutical Consulting. All Rights Reserved.