Ich botschaften beispiele pdf
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ich m13a, a draft guideline published in december, serves as the first in the series of beispiele m13 guidelines to describe the scientific and technical aspects of study design and data analysis to.  date of pdf step 4: 27 october 1994.  the international council for harmonisation of technical requirements of ich botschaften beispiele pdf pharmaceuticals for human botschaften use ( ich) is a unique harmonization organisation involving regulators and the.  this document gives recommendations on the numbers of patients and duration of exposure for the safety evaluation of drugs intended for the long- term treatment of non- life- threatening conditions.  the ich harmonised guideline was finalised under step 4 in october 1994.