Clinical tolerability and pharmacokinetics of Erigerontis hydroxybenzene injection: Results of a randomized phase I study in healthy Chinese volunteers

Author:

Ju Wen-Zheng,Zhao Yang,Liu Fang,Wu Ting,Zhang Jun,Liu Shi-Jia,Zhou Ling,Dai Guo-Liang,Xiong Ning-Ning,Fang Zhu-Yuan

Publisher

Elsevier BV

Subject

Complementary and alternative medicine,Drug Discovery,Pharmaceutical Science,Pharmacology,Molecular Medicine

Reference23 articles.

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4. FDA, 2005. Guidance for Industry Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). http://www.fda.gov/downloads/Drugs/Guidances/UCM078932.pdf.

5. FDA, 2013. Guidance for Industry Bioanalytical Method Validation. US Department of Health and Human Services, Food and Drug Administration. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM368107.pdf.

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