Tracy Purdue

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Regulatory guidances for drug stability testing during early development stages lack specifics. Consequently, companies either conduct more stability studies than necessary just to avoid regulatory questions or perform insufficient stability work resulting in regulatory questions and delays in drug development. Hence, there exist a pressing need and a great(More)
The U.S. Environmental Protection Agency (EPA) Federal Insecticide. Fungicide and Rodenticide Act and Toxic Substance Control Act Standards issued in 1989 presented a new task for the Quality Assurance Unit (QAU). Sections .190 and .195 of these Good Laboratory Practice (GLP) Standards require "quality assurance verification" prior to the disposal of(More)
Since the inception of the Food and Drug Administration's Good Laboratory Practice Regulations and Environmental Protection Agency's Good Laboratory Practice Standards, many "questions and answer" documents have been produced. Our purpose in this presentation is to pull together some of these reference documents and provide a cross-reference index to sort(More)
In pursuit of continuous process improvement, the authors streamlined the drug substance (DS) stress and stability testing process from preclinical to the first clinical batch. High temperature/high humidity stress and ICH Q1B confirmatory photostability testing on an early DS batch provide stability data that help quickly assess the new DS stability(More)
Immobility in hospitalized patients, particularly the elderly, can lead to serious untoward events. A pragmatic ambulation program that could be incorporated easily into clinicians' practice routines significantly improved ambulation in hospitalized patients compared to usual care with no organized emphasis on ambulation.
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