BIO375H5 Lecture Notes - Lecture 4: Outsourcing, Gene Therapy, Sample Size Determination
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Fda will do statistical tests to a certain phase in product development phases (phase 1,2,3 & 4) Ho(cid:449) to (cid:373)ake (cid:374)e(cid:449) produ(cid:272)t de(cid:448)elop(cid:373)e(cid:374)t (cid:862)less risk(cid:455)? (cid:863) If our product is a diagnostic product: specificity (using certain antibody to detect target specific protein, if they are able to detect other protein, hence it is not specific enough) > view more published paper for relying the results to a correct source. If the drug development process is struggling, should we keep going or abandon it right away (consider money) >generally early failure is better than late failure. Failing after the later phases (already spent a lot of money prior the clinical tests, development, other testing) Some pressures are hard to change, but some still can be changed. Failed drugs can be revived to be a successful drug. Preclinical, phase i-iii and fda review table *insert* Starting phase ii we need to target diseased population in order to test for efficacy and toxicity.
