NATALIA P, LIN X, CHANDRA P. Radiolabeled absorption, distribution, metabolism, and excretion studies in drug development: why, when, and how?. Chem Res Toxicol, 2012,25(3):513-531.
[2]
NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA). The Guidance on Non-clinical Pharmacokinetic Study (药物非临床药代动力学研究技术指导原则). (2014-05-13) . http://www. cde. org. cn/zdyz. do?method=largePage&id=21e45c8c5bacf662.
[3]
SWART P, LOZACH F,SIMON M, et al. The impact of early human data on clinical development: there is time to win . Drug Discov Today, 2016, 21(6):873-879.
[4]
NIJENHUIS C M, SCHELLENS J H M, BEIJNEN J H. Regulatory aspects of human radiolabeled mass balance studies in oncology: concise review . Drug Metab Rev, 2016, 48(2):266-280.
[5]
EUROPEAN MEDICINES AGENCY (EMA). Guideline on the investigation of drug interactions, Committee for Human Medicinal Products . (2013-01-01) . https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-drug-interactions-revision-1_en.pdf.
[6]
GB18871-2002, Basic Standards for Protection Against Ionizing Radiation and for the Safety of Radiation Sources. 2002.
[7]
STATE COUNCIL OF THE PRC. Regulations on safety of radioactive waste management. (2011-12-20) . http://www.gov.cn/zhengce/content/2011-12/29/content_4655.htm.
[8]
FOOD AND DRUG ADMINISTRATION(FDA). Code of Federal Regulations (CFR)-Title 21-Food and Drugs, Part 361.1. Radioactive drugs for certain research uses . FDA, (2019-04-01) . https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=361&showFR=1. 2019-04-01.
[9]
INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION(ICRP). Radiological Protection in Biomedical Research . Oxford: Pergamon Press, 1993:1-14.
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