1FDA, Guidance for industry nonclinical studies for development of pharmaceutical excipients (Draft) [EB/OL]. [ 2002 - 09 - 15 ].http ://www. fda. gov.
6ICH Steering Committee. Harmonised Tripartite Guideline S3A:Note for guidance on toxicokinetics: the assessement of systemic exposure in toxicity studies [EB/OL]. [1994-10 -27]. http://www.ich.org.
7ICH Steering Committee. Harmonised Tripartite Guideline S3B:Pharmacokinetics: guidance for repeated dose tissue distribution studies[EB/OL]. [1994-10-27]. http://www.ich.org.