Drug Preclinical Research

Drug Preclinical Research, Total:38 items.

The international standard classification for "Drug Preclinical Research" includes: Research and development , Medical equipment in general .

The Chinese standard classification for "Drug Preclinical Research" includes: Standardization and quality management , Medical apparatus and devices in general .

Group Standards of the People's Republic of China

T/CACM 1323-2019 Standard operating procedure for Chinese medicine data monitoring committee of clinical studies
T/CACM 015.11-2017 Formulation of technical specifications for the summary report of clinical research of traditional Chinese medicine
T/CACM 015.9-2017 Technical specification for the management of clinical research results of traditional Chinese medicine
T/CACM 015.6-2017 Training and management standards for clinical research coordinators of traditional Chinese medicine
T/SDHCST 003-2023 Pre-dose Quality Testing of Test Substances in Non-clinical Studies of the Cell Therapy Medical Products
T/CACM 015.10-2017 Drug Administration Standards for Clinical Research of Traditional Chinese Medicine
T/CAV 001-2023 Terms used in vaccine preclinical research
T/CACM 015.7-2017 Technical specifications for statistical analysis of clinical research of traditional Chinese medicine
T/CACM 015.1-2017 Specifications for formulation of randomized controlled clinical research protocols of traditional Chinese medicine
T/CACM 015.3-2017 Quality Control Standards for Clinical Research of Traditional Chinese Medicine
T/CACM 015.12-2017 Chinese medicine clinical research verification standards
T/CACM 015.8-2017 Standards for management of clinical research documents of traditional Chinese medicine
T/CGCPU 002-2016 The standard of on-site inspection for clinical investigational drug centralized management

DB34/T 4619-2023 Guidelines for the Construction of Intelligent Research Laboratory for Drug Phase I Clinical Trials

YY/T 1754.1-2020 Preclinical animal study of medical devices—Part 1:General considerations

Pharma-Guidelines-Nanodrug002 Technical Guiding Principles for Nonclinical Pharmacokinetic Research of Nanomedicines (Trial Implementation)
Pharma-Guidelines-Nanodrug003 Technical Guiding Principles for Non-clinical Safety Research of Nanomedicines (Trial Implementation)

BS EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects-Clinical investigation plans
NS-EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans (ISO 14155-2:2003)
BS EN ISO 11979-7:2006 Ophthalmic implants. Intraocular lenses. Clinical investigations
DANSK DS/EN ISO 14155/AC:2011 Clinical investigation of medical devices for human subjects - Good clinical practice

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 56702-2015 Medicines for medical applications. Nonclinical toxicology and pharmacokinetic studies of safety
GOST R 56699-2015 Medicines for medical applications. Preclinical safety evaluation of biotechnology-derived pharmaceuticals. General recommendations

KS P ISO 14155-2-2007(2012) Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans
KS P ISO 14155-2-2019 Clinical investigation of medical devices for human subjects－Part 2：Clinical investigation plans

BS EN ISO 11979-7:2006+A1:2012 Ophthalmic implants. Intraocular lenses. Clinical investigations
BS EN ISO 11979-7:2014 Ophthalmic implants. Intraocular lenses. Clinical investigations

EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

DIN EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
DIN EN ISO 14155-2 E:2001-08 Clinical Studies of Medical Devices for Human Use Part 2: Clinical Study Protocol (Draft)

TCVN 7740-2-2007 Clinical investigation of medical devices for human subjects.Part 2: Clinical investigation plans

UNE-EN ISO 14155-2:2004 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)

OS GSO ISO 14155:2015 Clinical investigation of medical devices for human subjects -- Good clinical practice

KS P ISO 14155-2022 Clinical investigation of medical devices for human subjects — Good clinical practice