Table of Contents
Chapter 1 INTRODUCTION
- 1.1. Why China: The Current High Level Perspective
- 1.2 Why China: Motivation and Strategic Considerations for Assessing the
China Opportunity
- 1.3. Why China: Emergence of the Preclinical CRO Sector
- 1.4. Why China: Trends in Safety Science Services and China' s Role
- 1.5. Report Background and Content
Chapter 2 THE STATE OF PRECLINICAL SAFETY SERVICES IN CHINA
- 2.1. Overview
- Organizational History
- High Profile Laboratories
- SFDA Accreditation
- SFDA vs. US/OECD GLP Standards
- 2.2. Industry Structure and Competitive Dynamics
- SFDA Labs
- Private Labs
- Additional Observations
- 2.3. Industry Infrastructure
- Language and Communication
- Protection of Intellectual Property Rights and Confidential
- Information
- Facilities
- Lab Space
- Lab Automation Systems
- Instrumentation
- 2.4. GLP Compliance
- 2.5. FDA Acceptance of Data, Laboratory Inspections
- 2.6. Human Resources, Key Job Categories, and Workforce Stability
- Examples of Personnel Limitations
- Pathology
- Laboratory Animal Health
- 2.7. Animal Husbandry and Supply
- Laboratory Animal Welfare
- Animal Supply
- Non-Human Primate (NHP) Studies
Chapter 3 COST COMPARISONS FOR PRECLINICAL SERVICES BETWEEN U.S. AND CHINA
- 3.1. Comparison Cost Examples
- 3.2. Management Oversight
- 3.3. Study Pricing
- Pricing Case Study
- Price Sustainability
Chapter 4 KEY PLANNING ISSUES TO ADDRESS WHEN PLACING STUDIES IN CHINA
- 4.1. Important Factors for Consideration
- Total Cost Elements
- Timing
- Range of Services
- Histopathology
- Study Management and Oversight
- Third Party Option.
- Laboratory Ownership
- Business Attitude
- Managing Regulatory Risk
- Closing Comment
Chapter 5 PRECLINICAL CROs IN CHINA
- 5.1. Introduction
- Beijing
- Shanghai
- Shenyang
- Chengdu
- 5.2. Laboratory Profiles
- BEIJING
- Bridge Laboratories - Beijing
- Summary and Background Information
- Facilities
- Operations
- Beijing Join - Beijing
- Summary and Background Information
- BioDuro - National Center for Safety Evaluation of
- Drugs National Institute for the Control of Pharmaceutical
- & Biological Products (NCSED)
- Summary and Background Information
- Facilities
- Operations
- National Beijing Center for Drug Safety Evaluation and
- Research/IPT (NBCDSER) - MicroConstants China
- Summary and Background Information
- Facilities
- Operations
- SHENYANG
- Shenyang Chemical Industry Research Institute, Safety
- Evaluation Center (aka National Shenyang Center for Safety
- Evaluation of New Drug - NCDSE & PSEC)
- Summary and Background Information
- Facilities
- CHENGDU
- National Chengdu Center for Safety Evaluation of Drugs
- (NCCSED) - Frontier BioSciences (NCCSED is also known
- as the West China-Frontier Pharmatech Co. Ltd.)
- Summary and Background Information
- Facilities
- Operations
- SHANGHAI
- Charles River Labs - China (formed as part of the Charles
- River Labs JV with Shanghai BioExplorer Co., Ltd.)
- Summary and Background Information
- Facilities
- Operations
- National Shanghai Center for New Drug Safety Evaluation
- & Research (NCDSER), Zhangjiang Hi-Tech Park
- Summary and Background Information
- Facilities
- Operations
- Medicilon-MPI, Zhangjiang Hi-Tech Park
- Summary and Background Information
- Facilities
- Operations
- WuXi AppTec, Wuzhong District, Suzhou, Jiangsu Province
- (1 - 1.5 hours from Shanghai)
- Summary and Background Information
- Facilities
- Operations
- ShangPharma, Zhangjiang Hi-Tech Park
- Summary and Background Information
- Facilities/Operations
- SNBL China
Summary and Background Information References and Notes
TABLES
- Table 3.1. Provides Cost Comparison for Sub-chronic Rat Studies and
- Chronic Monkey Studies
- Table 3.2. Cost Elements for System-to-Model Toxicology Costs
- Table 3.3. Cost Comparison for Preclinical Safety Testing - US vs.. China
- Table 3.4. Comparison of Cost Elements for Preclinical Studies -
- China vs.. US.
FIGURES
- Figure 1.1. Timeline of Major Developments in the Preclinical Safety Sector
- Figure 2.1. Western GLP Compliance Distribution in China and US
- Figure 3.1. Cost Comparisons - 6 Month NHP GLP Studies
- Figure 3.2. Cost Comparisons - 1-Month Rat GLP Studies
- Figure 4.1. Relative risk points associated with a typical IND submission
|
Related Report
|
View Cart
