Phase I Drug Clinical Trials
Phase I Drug Clinical Trials, Total:19 items.
The international standard classification for "Phase I Drug Clinical Trials" includes: .
The Chinese standard classification for "Phase I Drug Clinical Trials" includes: .
Professional Standard - Agriculture
- 农业部1247号公告-2-2009 Guiding principles for non-clinical pharmacokinetic tests of veterinary chemical drugs
- 农业部1596号公告-1-2011 Technical guidelines for clinical trials of traditional Chinese medicines and natural medicines for veterinary use
- 农业部1247号公告-4-2009 Guiding Principles for Phase II and Phase III Clinical Drug Efficacy Evaluation Trials of Antibacterial Drugs
- 农业部1247号公告-3-2009 Guiding principles for clinical pharmacokinetic tests of veterinary chemical drugs
- 农业部1596号公告-2-2011 Writing principles of clinical trial reports of traditional Chinese medicine and natural medicine for veterinary use
Anhui Provincial Standard of the People's Republic of China
- DB34/T 4619-2023 Guidelines for the Construction of Intelligent Research Laboratory for Drug Phase I Clinical Trials
Group Standards of the People's Republic of China
- T/CGCPU 014-2020 The practices of chemicals for clinical trials in clinical trial institutions
- T/CGCPU 006-2019 Phase I Clinical Trial Capacity Evaluation Criteria
- T/SHQAP 001-2023 Guidelines for the Construction of Quality Management Systems for Drug Clinical Trial Sponsors
- T/CACM 015.10-2017 Drug Administration Standards for Clinical Research of Traditional Chinese Medicine
- T/CGCPU 006-2023 Specification for competency assessment of phase I clinical trials
Hunan Provincial Standard of the People's Republic of China
- DB43/T 2135-2021 Technical Service Specifications for the Recruitment and Management of Drug Clinical Trial Subjects
ASHRAE - American Society of Heating@ Refrigerating and Air-Conditioning Engineers@ Inc.
- ASHRAE NO-94-29-1994 Validation of Pharmaceutical Clinical Supply Laboratories
RU-GOST R
- GOST R 56701-2015 Medicines for medical applications. Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals
- GOST R 57147-2016 Medicine for medical application. Nonclinical evaluation for anticancer pharmaceuticals
GOST
- GOST R 70355-2022 Specialized food products. General requirements for preclinical tests on laboratory animals
European Committee for Standardization (CEN)
- EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
- EN ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
British Standards Institution (BSI)
- BS EN ISO 14155:2011 Clinical investigation of medical devices for human subjects. Good clinical practice
Phase I clinical trial,Phase I clinical trial conditions,Overseas Drug Clinical Trials,Drug Clinical Trials,Phase I Drug Clinical Trials,Drug Clinical Trial Quality Management,Phase I Clinical Trial Design,The first phase of safety and pharmacokinetic clinical research