Sam C. Shum

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In-process tests are used between manufacturing steps to avoid the cost of further processing material that is apt to fail its final tests. Rapid microbiological methods that return simple negative or positive results are attractive in this context because they are faster than the compendial methods used at product release. However, using a single such test(More)
Some drugs are intended for sequential storage under two different storage conditions. If the data for each condition are analyzed separately, predicting assay and other responses after T1 months at one condition followed by T2 months at the other condition is non-trivial for several reasons. First, the two analyses will give different intercept terms. What(More)
UNLABELLED In-process tests are used between manufacturing steps to avoid the cost of further processing material that is apt to fail its final tests. Rapid microbiological methods that return simple negative or positive results are attractive in this context because they are faster than the compendial methods used at product release. However, using a(More)
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