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11 Cards in this Set
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- Back
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What is the purpose of Phase I trials?
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To gain some basic fundamtental dosing knowledge (AUC, half-life, metabolic pathways) on a new drug. No control. Health volunteers only.
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What is the purpose of Phase II trials?
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This is the first stage where the drug is given to patients. Efficacy, safety, and pharacokinetics (PK). Involves comparison groups usually. Placebos used.
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What is the purpose of Phase III trials?
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These trials focus on dose-finding and establishing efficacy as well as determining if there are adverse effets. Double-blinded, placebo-controlled. Success leads to an NDA (new drug application).
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What is the purpose of Phase IV trials?
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To do surveillance on an approved drug.
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What's an IND?
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An investigational new drug application.
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Why do randomized trials not always reflect how the drug will be used clinically?
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Randomized trials often include a number of exclusion criteria with their patient pool to simplify the study and do not investigate the effectiveness of the drug under more complicated scenarios.
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What document is a critical element of an RCT that shows the process of randomization and dropouts?
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A consort diagram
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What are the advantages of an enriched enrollment randomized withdrawal trial?
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They allow patients to be titrated to a set of tolerable dose which is then randomly compared to another control for some of these patients in the same cohort.
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What are some methods of sustained release?
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Waxy matrices (oxycodone), lipid foam (depomorphine), sustained release in a viscous solution (Sucrose acetate isobutyrate--Saber bupivacaine), transdermal iontophoresis (like a PCA pump without an IV), nanotab (sufentanil opioid),
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How are peripherally restricted opioid antagonists helpful in administering opioids?
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They can bind to intestinal opioid receptors, reducing constipation, without crossing the BBB and destroying analgesia (methylnaltrexone, alvimopan).
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How are nanosuspensions helpful with drug deliver?
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They increase the surface are of the drug delivery system allowing for pulmonary delivery and even cell-mediated delivery.
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