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The Contribution of SIFT-MS to Breath Analysis and Drug Research

AAPS | American Association of Pharmacueticals Scientists | Path Course Page

As a direct mass spectrometry, Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) is a novel tool to breath analysis and early-stage drug research. With SIFT-MS, the breath of a subject can be introduced into the instrument either directly or using thermal desorption tubes. The volatile profiles from a subject's breath can be used to screen for disease. E.g. Bowl cancer, lung cancer, Diabetes, etc. SIFT-MS could also be used to continuously monitor the volatiles released from tumor tissues, cancer cells or other biological relevant samples. The dynamic changes above cells during cell culture after certain drug candidates are introduced into the culture medium can be monitored by SIFT-MS in real-time. It will be useful to assess whether a potential drug candidate successfully drives a particular metabolic pathway. The volatile profile of tumor tissues could be valuable to differentiate cancer types or separate healthy subjects from patients.

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Course Objectives

Introduce the statute, regulation and guidance relationships.

Review positioning the quality pillars (GLP, cGMP, and GCP) in eCTD submissions.

Compare and contrast critical GLP roles and responsibilities from the perspectives of the Sponsor, Study Director, Principal Investigator and Quality Assurance.

Provide a detailed understanding of the relevant GLP formulation nuances.

Review ICH Q10 in-depth.

Gain insight into the value of linking development knowledge to manufacturing, and knowledge management to continuous improvement.

Differentiate how to perform appropriate quality investigations during development and commercial batch manufacturing, and when managing investigations of external vendors such as suppliers and CROs.

Discuss pertinent models for conducting clinical research, focusing on new drug development and approval.

Understand how to put GCP into action from obtaining Informed Consent, to composing a Protocol, to selecting Clinical Sites and ending with describing the Data Review Committee.