FDA-RFP_1155964_-_Question_and_Answer.doc
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- Pharmacokinetics Studies of Opioid Drug Product following Snorting of Milled Drug Products
- Solicitation number
- FDA-RFP-1155964
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FDA-RFP-1155964
Question and Answer
Question: In response to RFP-1155964, we would like to ask whether there is a particular test/reference opioid that the FDA wishes to investigate for this opioid snorting PK study, or shall we make our recommendation as part of the quote/proposal? Upon initial review, our PK team has suggested morphine tablets, however, if there is a particular opioid or dosage strength that is preferred for use in the study, please let me know.
Answer: A reference product with nasal abuse-deterrent labeling, for example, OxyContin, would be a preferred drug product of choice for this study.
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