Transcription of 1 2) ガイドラインアネックス 13 和訳
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1 2) ガイドラインアネックス 13 和訳
12) PIC/S GMP 13.. MANUFACTUREOFINVESTIGATIONAL . MEDICINALPRODUCTS. lnv estig ation alm e dicina lp rod uctss ho uldbe GMP j l . producedina cc or d ancew i tht h ep ri ncip lesandt h e . det ailedguid eline so fGoodM anufac turingPract ice . fo rM edic inalProducts .O therguid eline ss ho uldbe . takenintoaccountwherer el evantanda s . appr opriatetothes tag eo fdevelopmentofthe . pro roc eduresneedt obef le xib letop r ovide fo rc hangesask nowledgeofthep r ocessincrea ses, anda p propri atet othestageofd evelop mentoft h e pro duct. I. nclin ica ltria lst h eremaybeaddedr i skto L . p arti cipa tingsubjectscomparedt opati entst r eated . w ithmarketedp rod ppl icati ono fGMPt o GMP . t hem anufact u r eo finve stig atio nalm e dicinal . pr oductsisintendedtoe n suret h attri als ub jects . a ren otplacedatris k,andt ha tt heresul tso fcli nic al.
別紙（1 2) pic/s gmpガイドラインアネックス13 原文 和訳 manufacture of investigational 治験薬の製造 medicinal products ...
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