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GMS 6551 Module 2 (part 2) Exam | Questions And Answers Latest {} A+ Graded | 100% Verified
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GMS 6551 Module 2 (part 2) Exam | Questions And Answers Latest {} A+ Graded | 100% Verified
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GMS 6551 Module 2 (part 2) Exam | Questions And Answers Latest {2024- 2025} A+Graded | 100% Verified
What is the purpose of a Phase I trial? - To establish the maximum-tolerated dose and define
dose/schedule for Phase II trials.
What are the primary endpoints of a Phase I trial? - Maximum-tolerated dose and dose/schedule for
Phase II trials.
What are the secondary endpoints of a Phase I trial? - Optimal route of drug administration, drug half-
life, drug bioavailability, drug engagement of the target, and therapeutic efficacy.
What is the upside of Phase I trials? - Provides hope for patients who have exhausted other options.
What is the downside of Phase I trials? - Exposes patients to the highest probability of adverse events
with the lowest chance of therapeutic benefit.
What is the Critical Path for typical oncology drug development? - The steps between drug discovery
and FDA approval for commercial marketing.
What is Intellectual Property (IP)? - Protecting your invention/discovery.
What is an invention disclosure? - A process where U.F. decides whether or not to file a provisional
patent application.
Why should researchers disclose their work? - To increase the chances of commercializing their work.
What does the U.S. Patent and Trademark Office (USTPO) no longer accept? - Invention disclosures.
What is the link to the U.S. Patent and Trademark Office (USTPO) website? -
http://www.uspto.gov/patents/law/disclosure_document.jsp
,What is the link to the UF website about disclosing inventions? - http://research.ufl.edu/otl/for-uf-
inventors/should-i-disclose.html
What does an invention disclosure determine? - Whether or not to file a provisional patent application.
What happens if researchers do not disclose their work? - Their work is rarely commercialized.
What is the Bayh-Dole Act? - Legislation requiring employees to disclose intellectual property to the
Office of Technology Licensing.
What happens to intellectual property created by University employees? - University of Florida owns it,
unless waived back to the funding agency or inventor(s).
Under what circumstances does UF have rights to an invention? - If the invention was made while
employed at UF and in the same field, or if it was made with university resources.
What is a provisional patent application? - An application that provides 12 months of protection before
a patent application must be submitted.
What is the purpose of a provisional patent application? - To prevent a lapse in protection for a
discovery.
Where can I find more information about provisional patent applications? -
http://www.uspto.gov/patents-getting-started/patent-basics/types-patent-applications/provisional-
application-patent
What is an IND application? - Investigational New Drug application required for Phase I trials.
Where can I find more information about IND applications? -
http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approva
lapplications/investigationalnewdrugindapplication/default.htm
, What information must be included in an IND application? - Information on animal pharmacology and
toxicology studies, manufacturing, and clinical protocols.
What is the purpose of the animal pharmacology and toxicology studies information in an IND
application? - To provide information on the effects of the drug on animals.
What is the purpose of the manufacturing information in an IND application? - To provide details on
how the drug will be produced.
What is the purpose of the clinical protocols and investigator information in an IND application? - To
provide detailed protocols for proposed clinical studies and assess risks to subjects.
How long must a sponsor wait after submitting an IND application before initiating clinical trials? - 30
calendar days.
What is the purpose of the waiting period after submitting an IND application? - To allow the FDA to
review the IND for safety and ensure subjects won't be subjected to unreasonable risk.
What are the prerequisites for Phase I trials? - Governmental and institutional hurdles.
What is an Institutional Review Board (IRB)? - A board that reviews and approves research involving
human subjects.
What is the role of an IRB in Phase I trials? - To ensure the protection of human subjects in the proposed
clinical studies.
What information must be included in an IND application for Phase I trials? - Animal pharmacology and
toxicology studies, manufacturing information, and clinical protocols and investigator information.
What is an IRB? - Review board for human subject research approval.
What is Informed Consent? - Permission given by participants in a study after being informed.
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