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Home » Drugmakers Get Tips on Biotech Drug Dose Selection in Guidance Addendum
Drugmakers Get Tips on Biotech Drug Dose Selection in Guidance Addendum
June 6, 2012
Drugmakers will see more explanation of the proper nonclinical steps to support safety of clinical trials and marketing applications for biotech drugs in an International Conference on Harmonisation (ICH) guidance addendum, just issued by the FDA.