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Material and Clinical Trial Requirements of Application and
Approval for Imported Drug Registration: A Guidebook of
Registration Application for Imported Biological Products
China Pharmaceutical Guidebook Series (4) (4th edition)



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The biopharmaceutical industry is one of the burgeoning industries. In the field of
biopharmaceuticals, vast knowledge awaits people to explore. The
biopharmaceuticals are diversified and complex. In China, the development of
biopharmaceutical industry is far behind the developed countries. Just for this
reason, the requirements of materials and clinical trials for registration application
of biopharmaceuticals stipulated by the Chinese pharmaceutical authority are far
from systematic and uniform.

Report Highlights :

 The classification of biological product registration
 The material items for application of biological product registration
 The requirements of material items for application of biological product
registration
 The requirements of clinical trial for application of biological product registration
 The guideline for application of biological products for human gene therapy
 The guideline for application of biological products for somatic cell therapy
 The guideline for application of biological products for allergic therapy
 The significant suggestions for overseas pharmaceutical manufacturers and
producers looking to achieve a successful application for their biopharmaceuticals
registration in China.
 Many useful resources of law and regulations, including the Drug Administration
Law of the People’s Republic of China, the Regulations for Implementation of the
Drug Administration Law of the People’s Republic of China, the Chinese Good
Clinical Practice of Pharmaceutical Products, the Chinese Good Manufacturing
Practice for Pharmaceutical Products, the Form of Registration Application for
Imported Drug, and so on.
 Who should buy this report?

Table of contents:

Preface
Chapter 1. Introduction
Part 1. Therapeutic Biological Products
Chapter 2. Classification of Therapeutic Biological Product Registration
Chapter 3. Material Items for Application of Therapeutic Biological Product
Registration
3.1. Comprehensive Materials
3.2. Research Materials of Pharmaceutics
3.3. Research Materials of Pharmacology and Toxicology
3.4. Materials of Clinical Investigation
3.5. Miscellaneous
Chapter 4. Requirements of Material Items for Application of Therapeutic Biological
Product Registration
4.1. The Form of Material Items
4.2. The Explanatory Notes of Material Items
Chapter 5. Requirements of Clinical Trial for Application of Therapeutic Biological
Product Registration
5.1. General Requirements of Clinical Trial
5.2 Special Requirements of Clinical Trial for Imported Therapeutic Biological
Products
Part 2. Prophylactic Biological Products
Chapter 6. Classification of Prophylactic Biological Product Registration
Chapter 7. Material Items for Application of Prophylactic Biological Product
Registration
7.1. Comprehensive Materials
7.2. Summary and Evaluation of Research Results
7.3. Research Materials of Bacterial (Toxic) Seeds for Production Use
7.4. Research Materials of Cell Matrix for Production Use
7.5. Research Materials of Production Technique
7.6. Experimental Materials for Quality Study
7.7. Regulation Draft of Production and Assay, Drafting Explanation of Regulation,
Relevant Literature.
7.8. Records of Production and Assay for Samples to Apply for Clinical Trial
7.9. Research Materials of Initial Stability Study
7.11. Plan and Scheme for Clinical Trial.

List of Figures

List of Tables are also include.



For more Reports Plz follow The link:

Material and Clinical Trial Requirements of Application and Approval for Imported
Drug Registration: A Guidebook of Registration Application.... China Pharmaceutical
Guidebook Series (3)(4th edition)

Material and Clinical Trial Requirements of Application and Approval for Imported
Drug Registration: A Guidebook of Registration Application for Imported Biological
Products China Pharmaceutical Guidebook Series (4) (4th edition)

Invest in China: A Guidebook for Application and Approval of Establishment
Registration for Foreign Investment Enterprises(The Invest in China Guidebook
Series (1)

China Pharmaceutical Guidebook: Latest Chinese Regulations for Imported Drug
Registration(4th Edition)

Chinas Guidebook for Pharmaceutical Patent Protection
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