PCL102H1 Lecture Notes - Lecture 21: Xenotransplantation, Oncogene, Informed Consent

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Reformulation of drug for better pharmacokinetics: patients were not absorbing the drug, the doctor wanted to test the drug at a lower dose before giving it to more patients in a larger trial this would require retooling the drug in a costly/complicated task that may not even work, the doctor would also have to make his case to 2 companies that had already poured hundreds of millions of dollars into the drug and were eager to move it forward, the new drug was 10 times as potent as the previous one, packaged in a way the body could more easily absorb (better pharmacokinetics) Examples of biomarkers: cancer imaging scan (before and after, before o black spots regions of spread melanoma tumours, after o on the drug for 15 days disappearance of dark spots therefore, the tumours are shrinking > this type of efficacy was surprising for doctors since this pathway had not been investigated previously.

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