Contrary to popular belief, early formulation development is not simply dumping API in a vehicle and gavage feeding an animal.  If you do this, you will most likely lose time and money with unnecessary and confusing PK studies.  This led to the development of our SMART biopharmaceutical solutions that offer input from our scientific advisory board:  A one-stop shop from candidate selection through early development.  

This is an integrated approach to find the right form and formulation every step of the development cycle using decision trees and guidance documents built from our over 80 years of innovative pharmaceutical experience. Using our SMART services will lead to the shortest possible development timelines with limited resource utilization.

Preclinical and Tox Formulation - Resources

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• Webinars

  Rational Preclinical Formulation Development through Solid Form Selection, Modeling and Automated Formulation, Chonghui Gu, Agios Pharmaceuticals

• Integrated Phase and Formulation Selection to Support GLP Toxicology and First in Human Studies. Nathalie Toussaint and Annette Bak, Merck

• Pre-clinical Formulation Strategies: Keeping Up with Changing Paradigms in Drug Discovery and Development, Shobha Bhattacher, Eli Lilly

• Efficient Preclinical Formulation Development for Poorly Soluble Compounds, Christopher Lindemann, Focus Pharmaceuticals

• Polymorphism of Drugs- Can We Exploit Physical Form in the Development of Low Solubility Molecules? Elizabeth Vadas, InSciTech

• The Formulators Toolbox: Designing and Developing Disordered Systems, Jayne Hastedt, JDP Pharma

• The Use of Amorphous Solid Dispersions to Enhance Dissolution and Oral Bioavailability of Poorly Water-soluble Pharmaceutical Compounds, George Zografi, University of Wisconsin-Madison

• Publications

  Drug Development- Don’t Overlook Key Preclinical Research. Drug Dev. Deliv.. 2016, 16(3), 66-72 

• A Solid-state Approach to Enable Early Development Compounds: Selection and Animal Bioavailability Studies of an Itraconazole Amorphous Solid Dispersion. J. Pharm. Sci. 2010, 99(9), 3901-3922. (free download)

• An Integrated Approach to the Selection of Optimal Salt Form for a New Drug Candidate. Int. J. Pharm. 1994, 105, 209-217.