Essay on CardioPharma Mecamylamine

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CardioPharma Mecamylamine Assignment Paper
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Discussion Points:
1. a. The Hopkins incident uncovered some serious problems with the investigator and the IRB committee. As a sponsor’s representative you should make sure that your investigator submits complete and detailed study information to the IRB necessary for approval

If your company is using a previously approved drug for a new route of administration you should consult with the FDA to see if an IND needs to be submitted prior to the start of a clinical trial. You must make sure the investigator keeps detailed records of any medications dispensed. All adverse or unexpected events must be submitted to the IRB in a timely fashion. If the investigator change any part of
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5. The sponsor/clinical investigator failed to disclose that inhalation administration of hexamethonium was an experimental use of the drug in the consent form, so the subject were unable to give an effective informed consents.
6. The hexamethonium prepared for administration to the subjects was not pharmaceutical grade material and approved for use in humans.****

1. c. In the Hopkins incident the IRB committee did not fully discharge its responsibility for this study and committed some serious errors. They failed in their responsibilities in several different areas from an inadequate review of the protocol regarding issues concerning safety of the subject in regards to the language of the actual consent form. The IRB committee also did not follow the guidelines for protocol review in the approval of this study. The IRB should have reviewed the study at a properly convened meeting.

The IRB did not require Dr. Togias to submit more evidence supporting the safe use of inhaled hexamethonium. The four studies Dr. Togias used in his proposal supporting the safety of inhaled hexamethonium only included 20 patients, which is not enough to document toxicity and adverse events. Inhalation of hexamethonium had only been performed in a small sample of volunteers; under these circumstances the IRB should have asked the principal

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