10-year outlook and may include marketing experts, drug delivery scientists, a licensing expert, and a patent lawyer. Members of the team ask and answer questions for senior management such as: What is currently available to treat the targeted disease? What is the total market for this lesion? How long will it take to bring the proposed drug delivery system to market? Will the product be protected by patents and will it have freedom to practice? Are there superior drug delivery systems, which should be licensed from an outside individual or group? What will the competition look like by the time the product is introduced? Will the proposed product be sufficient to take a reasonable piece of the competitions market at the time of approval?

It should be understood that by the time the new drug is approved, perhaps some 5–10 years hence, the current-year competition may have a strong foothold in the world market; consequently, it may take a significant advantage for the newcomer to compete. Furthermore, one must assume that the competition is not standing still; it is developing its next generation pharmaceutical. Therefore, there is a clear need to design a product, which will not only be superior to the competitor’s current product but will leapfrog the competitor’s next generation therapy.

Depending on the team’s findings and senior management’s direction, the strategic team may provide invaluable input into the current and future drug delivery system requirements. For example, the team may nix a concept for a product designed to be equivalent to the current Lucentis intravitreal injection because, by the time this new product reaches market, it is likely that it will be competing with the next generation of that drug. The team might redirect the research efforts toward leapfrogging the competition 7 years down the road.

This strategic logic applies to nonprofit organizations. Being free of the obligation to run a profitable business, nonprofits have more latitude to synthesize and investigate new drugs, discover novel disease-mitigating pathways, develop new drug delivery devices, and/or evaluate “out of the box” therapies. Why, then, would such organizations waste precious resources trying to match a therapy, which is currently available?

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Chapter 2

Microdialysis for Vitreal Pharmacokinetics

Ravi D. Vaishya, Hari Krishna Ananthula, and Ashim K. Mitra

Abstract  Microdialysis has been an instrumental sampling technique to study ocular pharmacokinetics without sacrificing a huge number of animals. It has undergone significant transformations in the last decade and several animal models have been established for sampling inaccessible posterior segment tissues such as vitreous humor. Remarkable progress has been made in the probe design and validation techniques. In the following chapter we have discussed the principle and development of various animal models related to posterior segments.

A.K. Mitra (*)

Division of Pharmaceutical Sciences, University of Missouri-Kansas City, School of Pharmacy, 2464 Charlotte Street (HSB-5258), Kansas City, MO 64108-2718, USA

e-mail: mitraa@umkc.edu

AAPS Advances in the Pharmaceutical Sciences Series 2, DOI 10.1007/978-1-4419-9920-7_2, © American Association of Pharmaceutical Scientists, 2011