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Formulation Development, Testing, and Approval

Formulation development , Testing, and Approval Part I of 2. Leon H. Kircik, MD, Joseph B. Bikowski, MD. David E. Cohen, MPH, MD. Zoe Diana Draelos, MD. Adelaide Hebert, MD. March 2010. Ve h i c l e s M a t t e r W elcome to Vehicles Matter, Part I, the first in a two-part series that explores the important role of the vehicle on the efficacy, safety, and tol- erability of a drug Formulation . Starting with the process of Formulation plan- Table of Contents Topical Drug Delivery .. 3. ning through the FDA Approval process , this first edition of Vehicles Matter Penetration Enhancers: elucidates the critical considerations that go into designing a new topical Benefits and Challenges .. 6. therapy. In Part II (June 2010), we'll take a closer look at specific drug formula- tions in order to better understand the unique ways that these various prod- Topical Dosage Forms .. 8. ucts address the challenges of Formulation to ensure tolerability and efficacy.

Vehicles Matter Welcome to Vehicles Matter, Part I, the first in a two-part series that explores the important role of the vehicle on the efficacy, safety, and tol-erability of a drug formulation. Starting with the process of formulation plan-

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