Introduction
This book is based on the latest relevant laws and regulations of my country and the GCP of developed countries or international organizations, mainly the WHO and ICH GCP guidelines. Foreign materials, combined with the experience and experience of participating in and organizing domestic and foreign GCP training.
This book is mainly for doctors, nurses, pharmacists and file managers in medical units engaged in drug clinical trials, as well as personnel in pharmaceutical companies engaged in new drug registration or GCP inspectors as an introductory reading. It can also be used at all levels It can be used as a reference book for all kinds of GCP training courses for personnel engaged in GCP supervision and inspection by the drug regulatory authority.
Book Catalog
Part Ⅰ Introduction to Drugs’ Prompt Trial
1 Procedures for Drug Research and Development
Discovery of the first compound
>Animal experiment
Phase I clinical trial
Phase II clinical trial
Benefit-risk ratio
Phase III clinical trial
Applying for drug registration or marketing authorization
Phase clinical trials
Adverse reactions and revocation of permits
2 Significance of the trial for social entertainment
Evaluate the application value of new drugs for temporary entertainment
Determine the best use method of new drugs
Provide new drug registration information
For enterprise new drugs Research and market development decision-making provide basis
Provide basis for doctors and patients to use new drugs correctly
Health economics evaluation
3 Basic elements of temporary entertainment trials
p>Basic principles of drug clinical trials
Research risks and protection of subjects
Approved by the competent authority
Clinical trial protocol
p>Case report form
Experimental purpose
Control
Experimental design
Random
Get Balanced treatment group
Blind trial
Sample size
Placebo
Double-blind and double-simulation technology
Multicenter clinical trial
Baseline and endpoint
Dosing schedule
Dose-response relationship
Compliance
< p>4 Evaluation of clinical trials5 Implementation procedures of clinical trials
Guidelines for the quality management of clinical trials of drugs in the second edition
6 GCP overview
p>7 GCP implementation in China
8 GCP protection for subjects
9 GCP requirements for the responsibilities of relevant personnel
10 Clinical Management of trial documents and data
11 GCP's assurance of clinical trial quality
12 Factors and countermeasures affecting the success of clinical trials
Part III Appendix< /p>
Appendix Ⅰ "Regulations for the Management of Drug Coordination Trials"
Appendix II ICH GCP Guidelines on Requirements for Necessary Documents for Drug Coordination Trials
Appendix III Helsinki Declaration ( Revised edition in 2000)
Appendix IV "Administrative Measures for Drug Registration (Trial)" Provisions on Drug Clinical Research
Chinese version of professional terminology
References< /p>