...working with Altasciences has been excellent, from both a bioanalytical, and a bioavailability study perspective. We are really impressed with their planning and execution abilities – I would not consider another provider for future work.
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In Phase I ethnobridging clinical trials, there are three primary protocol design concepts utilized. These concepts align the strategy with global clinical development and measure key factors necessary for meeting the unique needs of the Sponsor.
Altasciences is expanding its current clinical operations in Montreal and Kansas City with the addition of a clinical CRO on the U.S.A.'s West Coast. Click below to read more about the acquisition of WCCT Global.
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From formulation development, Phase I through commercial manufacturing, and ICH stability testing
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The purpose of First-In-Human (FIH) trials is to study the human pharmacology, pharmacokinetics (PK) and pharmacodynamics (PD), tolerability, and safety of an investigational medicinal product (IMP) having already gone through preclinical studies, and to evaluate how the effects translate from animals to humans. They allow sponsors to determine potential risks associated to the drug at each step of its development and determine the safe dose range in the course of its clinical progression.
In this issue of The Altascientist, we discuss:
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