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/246246/2006092815540133Identity, strength, quality, and purity of a drug product. Sampling plan and acceptance criteria required by USP XXII/NF XVII for content uniformity testing [905] dissolution testing [711] disintegration testing [701] Approximate probabilities can be computed for passing USP testing. Acceptance limits also can be established to pass USP testing with a high probability. Tolerance limit approach can be used to set up the in-house specifications.application/ppt1078272 bytesapplication/vnd.ms-powerpointzh-TWStatistical Methods for Biotechnology Products-USP Tests and Specificationslearning objecthttp://ntur.lib.ntu.edu.tw/bitstream/246246/2006092815540133/1/biotechnology03.ppt