FDA Draft Guidance for Exploratory IND Studies issued on April 7, 2005 recommends use of microdosing techniques.

(Philadelphia, Pa. May 10, 2005.) – MDS Pharma Services, a leading provider of innovative drug discovery and development solutions, has announced that their Tampa, Fla., pharmaceutics division has expanded manufacturing capabilities to include precision microdosing automation, enabling clients to conduct Phase 0 studies and move efficiently toward clinical proof-of-concept. These capabilities are in close alignment with FDA efforts to streamline drug development by endorsing the use of exploratory IND studies which, as defined by the FDA, involve very limited human exposure and no therapeutic intent (e.g. screening studies, microdose studies).

According to a recent BioBusiness Report, “Phase 0 studies involve microdoses or very short-term exposure to doses that are pharmacologically active, but not toxic, and could yield data that are not available from animal tests.” A recent Pharmaceutical Technology publication also supports the use of automatic gravimetric powder-filling machines to quickly manufacture CIC (Chemicals in Capsule) supplies for microdosing.

The FDA's March 2004 Critical Path Report and recent Guidance cite a number of advantages associated with exploratory IND studies, including reduced preclinical requirements and the ability to identify promising drug development candidates earlier in the process, thereby reducing the time and resources devoted to drug development candidates that are unlikely to succeed.

Dr. Robert Butz, MDS Pharma Services vice president, Global Regulatory Affairs, states, “Phase 0 studies provide an important opportunity for pharmaceutical and biotechnology companies to establish clinical proof-of-concept with smaller doses, thereby accelerating the path to reach critical scientific and financial milestones.”

“Phase 0 studies require accurate yet flexible methods for weighing and preparing small doses as well as highly sensitive bioanalytical methods to measure drug in plasma or blood. Access to these technologies is essential before one can define pharmacokinetics and any pharmacodynamics responses at subtherapeutic doses,” adds Dr. J. Fred Pritchard, MDS Pharma Services vice president, Drug Development Programs. “MDS Pharma Services Pharmaceutics provides the solution for dose preparation requirements for phase 0 studies.”

MDS Pharma Services offers a full spectrum of resources to meet the drug discovery and development needs of the pharmaceutical and biotechnology industries. With numerous facilities strategically located around the world, the company applies advanced scientific and technological expertise to each stage of the drug discovery and development process – Early Stage: lead optimization, pre-IND research, pharmaceutical and biopharmaceutical development, early clinical research (bioequivalence, phases I-IIa) and bioanalysis; and Late Stage: global clinical development (phases IIb-IV) and central lab. For more information, visit MDS Pharma Services' Web site at www.mdsps.com.

MDS Pharma Services is an integral part of MDS Inc. (TSX: MDS; NYSE: MDZ). MDS Inc. has more than 9,000 highly skilled people in 25 countries providing a diverse range of superior products and services to increase our customers' speed, precision and productivity in the drug development and disease diagnosis processes. We are a global health and life sciences company, recognized for our reliability and collaborative relationships. Please refer to our website at www.mdsintl.com to find out more about how we help create better outcomes in the treatment of disease.