Publisher :
China Medical Science and Technology PressPublished Date : 11/2010
Language : Chinese
ISBN/ISSN : 9787506747110
Pages : 865
Weight : 2.30kg
Availability : Usually ship within 48 hours
Book Type : Reference
Estimated Shipping Time"The latest drug registration regulations and guidelines," a comprehensive collection of our current drug registration regulations the latest files and nearly 80 technical guidelines for drug research, highlights the comprehensive, authoritative and practical features. Publication of the book on the popularization of national regulations and policies related to drug registration, drug regulatory system to comprehensively promote administration according to law, to guide science and pharmaceutical companies conduct drug registration work will play a positive role in promoting.
The first part of the laws and regulations
Drug Administration Law of the People's Republic
PRC Drug Administration Law Implementing Regulations
The second part of the drug registration regulations file
Regulation
Drug Registration
Non-clinical studies of drug quality control standards
Clinical trials of drug quality control standards
Direct contact with drug packaging materials and container management practices
State Food and Drug Administration drug approval procedures in particular
Medical registration of pharmaceutical management approach
Package insert and labeling regulations
Registration matching requirements
Special approval of new drug registration regulations
Drug Registration on-site inspection regulations
Drug Registration on-site inspection and sampling program and requirements (Trial)
Site inspection on the implementation of drug registration regulations to inform the problem of convergence
Registration provides pharmaceutical technology transfer
Chinese medicine, natural medicine, the basic technical requirements of injection
Regarding the development of traditional Chinese medicine injection safety re-evaluation of the notice
On the issuance of "Chinese Medicine Registration supplementary regulations," the notice
On the issuance of "a number of pharmaceutical clinical research regulations," the notice
On the issuance of "Provisional Regulations on experimental records pharmaceutical research," the notice
On the issuance of "drug clinical trial Qualification (Provisional)" notice
On the issuance of non-clinical studies of drug quality control standards certification management practices to inform
Chemical injection and on the promulgation of multi-component injection biochemical basic technical requirements of the notice
The third part of the technical guidelines for drug research
Chemicals
Listed chemical changes of the technical guidelines (a)
Genetic toxicity studies of drug technical guidelines
Synthetic peptide drug pharmaceutical research technical guidelines
Oral sustained-release formulations of chemical drugs Pharmaceutical Research technical guidelines
Inhaled formulations of technical guidelines for quality control
Non-clinical studies of drug dependence technical guidelines
Clinical efficacy of anti-HIV drugs non-technical guidelines for research
Chiral drug quality control of technical guidelines
Reproductive toxicity studies medicines technical guidelines
Non-cytotoxic anticancer drugs technical guidelines for clinical research
Chemicals review the format and content of written information on the technical guidelines
- A summary of major findings and evaluation
Chemicals review the format and content of written information on the technical guidelines
- The subject and based on established
Chemicals review format and content of written information on the technical guidelines
- Pharmaceutical Research data Summary
Chemicals written disclosure of information format and content of the technical guidelines
- Summary of pharmacology and toxicology research data
Chemicals written disclosure of information format and content of the technical guidelines
- Summary of clinical trial data
Been the national standard guidelines for chemical research techniques
Long-term toxicity testing of chemical substances technical guidelines
Chemical analysis of drug quality control guidelines for verification
Chemicals during the standardization of quality standards established technical guidelines
Chemical Pharmaceutical Research guidelines for the basic technology
Chemicals impurities of the technical guidelines
Chemical structure of drug clinical trial reporting guidelines and content technology
Clinical pharmacokinetics of chemical drug research technical guidelines
Chemicals irritant, allergic and hemolytic studies technical guidelines
Chemical pharmaceutical bioavailability and bioequivalence studies technical guidelines
Preparation of bulk drugs and chemicals structure of confirmation of the technical guidelines
Chemicals general principles of pharmacology research technical guidance
Chemotherapy residual solvents of the technical guidelines
Chemical drug stability study technical guidelines
Acute toxicity tests of chemical drugs technical guidelines
Chemicals non-clinical pharmacokinetic study of technical guidelines
Chemical drugs and biological products in clinical trials guidelines for biometric technology
Chemicals, biological products, guidelines for manual
Chinese medicine, natural medicine
Chinese medicine, natural medicine, review the format and content of written information technology guidelines
- Summary of pharmacology and toxicology research data
Chinese medicine, natural medicine, review the format and content of written information technology guidelines
- Summary of clinical trial data
Chinese medicine, natural medicine, review the format and content of written information technology guidelines
- A summary of major findings and evaluation
Chinese medicine, natural medicine, technical guidelines stability
Chinese medicine, natural medicine, the principle of long-term toxicity study of technical guidance
Chinese medicine, natural medicine, review the format and content of written information technology guidelines
- Pharmaceutical Research data Summary
Chinese medicine, natural medicine preparation of technical guidelines
Chinese medicine, natural medicine, raw materials before processing guidelines
Chinese medicine, natural medicine, immune toxicity (hypersensitivity, allergic reactions of light)
Chinese medicine, natural medicine in the pilot study of technical guidelines
Chinese medicine, natural medicine, general pharmacology technical guidelines
Chinese medicine, natural medicine, pharmaceutical instructions written guidelines
Chinese medicine, natural medicine extraction and purification process of the technical
Chinese medicine, natural medicine application of medical theory and clinical research literature written principles
Chinese medicine, natural medicine, the principles of clinical trial report writing
Chinese medicine, natural medicine, irritation and hemolysis studies technical guidelines
Chinese medicine, natural medicine, acute toxicity studies of technical guidelines
Biological products hoe
Vaccine clinical trials to prevent adverse reactions with the standard guidelines for grading
Preclinical studies with vaccines to prevent technical guidelines
Biological products production process change management guidelines
Combination vaccine pre-clinical and clinical research techniques guidelines
Conjugate vaccine quality control guidelines and clinical research techniques
Technical guidelines for vaccine clinical trials
Peptide vaccine production and quality control technology guidelines
Prevention of pre-clinical studies with the DNA vaccine technology guidelines
Prevention for the virus as a carrier of the vaccine formulations of the technical guidelines
Recombinant DNA products for human use guidelines for quality control
Cell culture with bovine serum production and quality control guidelines
Human monoclonal antibody with the principles of quality control, technical guidance
Preparation of human cell therapy research and quality control guidelines
Human gene therapy research and preparation of technical guidelines for quality control
Allergens (allergens) product quality control guidelines
HIV vaccine clinical research technical guidelines
Blood products to remove / inactivate viruses technical methods and validation guidelines
Clinical studies in vitro diagnostic reagents technical guidelines
In vitro diagnostic reagents guidelines for the preparation instructions
Recombinant production of mammalian cell products, technical evaluation of the general principles of quality control
Preventive biological products pre-clinical safety evaluation of the technical review of general principles
Vaccine production with the extracellular matrix of the general principles of the technical review
Tissue extract products and products of eukaryotic cells the virus safety evaluation technology
Review of general principles
Quality control analysis of biological products technical review of the general principles of method validation
New
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