國立臺灣大學農藝學系Liu, Jen-PeiJen-PeiLiu2006-09-282018-07-112006-09-282018-07-112006http://ntur.lib.ntu.edu.tw//handle/246246/2006092815540143Stability data from long-term studies under ambient conditions ( nonaccelerated data). Shelf-life FDA Guideline(1987) p.29"to establish, with a high degree of confidence, an expiration dating period during which the average drug product characteristic(i.e.,strength) of the batch will remain within specifications. This expiration dating period should be applied to all future batches..." p.30"Also, percent of label claim, not percent of initial average-value, is the variable of interest."application/ppt1152512 bytesapplication/vnd.ms-powerpointzh-TWlearning objecthttp://ntur.lib.ntu.edu.tw/bitstream/246246/2006092815540143/1/biotechnology07.ppt