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Raleigh, NC, United States, 2009/06/16 - Company officials credit Phase I success to knowledge, experience and a process that works - MetricsInc.com.
Metrics Inc. recently completed its 100th “first in man” Phase I study, a significant milestone within the contract pharmaceutical development industry.
“This achievement reflects two important facts about Metrics: One, we have demonstrated scientific expertise in Phase I work and, two, we’ve had such scientific expertise for quite a while,” said Dr. Thomas B. Gold, director of pharmaceutical development and new technology.
As defined by the U.S. Food and Drug Administration, a Phase I study introduces an investigational new drug into humans. Closely monitored and usually conducted in healthy volunteers, a Phase I study assesses issues such as safety, tolerability, pharmacokinetics and pharmacodynamics, and normally includes dose escalation. Armed with such information, pharmaceutical companies can design a well-controlled and scientifically valid Phase II study.
A Phase I study presents special challenges that Metrics’ seasoned scientists are experienced in handling, such as formulating the active and inactive components of an investigational drug and determining the correct dosage, Gold said. Metrics has particular expertise in oral dosing.
“There’s a good deal of science in a Phase I study in terms of chemical and physical compatibility of the active pharmaceutical ingredient with other functional components within the tablet or capsule,” Gold said. “The fact we’ve managed more than 100 first in man studies for leading companies proves we’ve got an excellent process for conducting Phase I work and our clients know it.”
Last year, Metrics completed an $18-million, 47,000-square-foot expansion that doubled its overall facility size and dramatically grew service offerings to clients. Because of its expansion, Metrics’ capacity for Phase I work increased and the company now can conduct more such studies concurrently. Metrics also can scale up studies as needed through Phase III and commercial, keeping them under one roof.
Metrics’ facility addition included a new larger scale manufacturing facility with a production capability of 1 billion tablets per year; four new analytical laboratories; stability storage; a totally segregated cytotoxic and potent compound development facility; and a microbiology laboratory.
Headquartered in Greenville, N.C., Metrics Inc. (metricsinc.com) provides quality pharmaceutical formulation development, clinical trial material (Phase I, II and III) and commercial manufacturing, and analytical development/validation services to the pharmaceutical industry. The company is one of the fastest-growing contract pharmaceutical development laboratories in the United States today.