印度藥品產業

印度藥品產業 是由出版商Trimark Publications在2008年07月所出版的。 這份英文市場調查報告書包含207 pages 價格從美金1999起跳。

簡介

目錄

Abstract

The purpose of this TriMark Publications study is to describe the specific segment of the pharmaceutical market sector called the Indian pharmaceutical industry. This sector includes all of the generally-accepted pharmaceutical manufacturing activities that are currently used today, including the bulk drug industry, formulations and major therapeutic segments. It examines these clinical supplies as utilized in hospitals, clinics and doctor' s offices. The principal objectives of this analysis are to: 1) identify viable technology drivers through a comprehensive look at various platform technologies for the Indian pharmaceutical industry; 2) obtain a complete understanding of the Indian pharmaceutical industry practices from its basic principles to its applications; 3) discover feasible market opportunities via an identification of high-growth applications in different areas of the Indian pharmaceutical industry, with a focus on the biggest and expanding markets for the Indian pharmaceutical industry; 4) focus on global industry development through an in-depth analysis of the major world markets for pharmaceutical manufacturing, including forecasts for growth; and 5) establish the essentials of the Indian pharmaceutical market including definitions, processes and trends.

Table of Contents

• 1. Overview
  • 1.1 Statement of Report
  • 1.2 Scope of the Report
  • 1.3 Methodology
  • 1.4 Executive Summary
• 2. Introduction
  • 2.1 India' s Pharmaceutical Market to Triple Over the Next Decade
  • 2.2 Indian Pharma' s Global Foray
  • 2.3 New Investments in 2007
  • 2.4 Contract Research Deals in 2007
  • 2.5 India' s Major Pharma Export Destinations
• 3. The Indian Market
  • 3.1 Projected Market Size
  • 3.2 Present Core Competence
  • 3.3 Analysis of Market
  • 3.4 Indian Biotechnology Industry-A Snapshot for Investors
  • 3.5 Genome Valley
• 4. Characteristics of the Indian Pharmaceutical Industry
  • 4.1 Profitability
  • 4.2 Location
  • 4.3 Segmentation of the Indian Pharmaceutical Industry
    • 4.3.1 Bulk Drug Industry
      • 4.3.1.1 Production and Exports of Drugs and Pharmaceuticals
      • 4.3.1.2 Projections for Bulk Drugs and Formulations-1997-1998 to 2001-2002
    • 4.3.2 Formulations
  • 4.4 Major Therapeutic Segments
• 5. Key Players in the Indian Pharmaceutical Industry
  • 5.1 Contract Manufacturing and Clinical Trials in India
    • 5.1.1 Multinational Corporations (MNC' s) Playing a Critical Role
      • 5.1.1.1 Glaxo
      • 5.1.1.2 Glaxo SmithKline India
      • 5.1.1.3 Pfizer India
      • 5.1.1.4 Aventis Pharma
    • 5.1.2 Aventis' New Introductions
      • 5.1.2.1 Performance Drivers
      • 5.1.2.2 Aventis Pharma
    • 5.1.3 Novartis India
      • 5.1.3.1 Novartis' Performance in Pharmaceuticals, 2007
      • 5.1.3.2 Novartis' Performance in Vaccines and Diagnostics, 2007
  • 5.2 Key Indian Players
    • 5.2.1 Ranbaxy
      • 5.2.1.1 Analyses
      • 5.2.1.2 Ranbaxy' s R&D Pipeline
      • 5.2.1.3 Ranbaxy
    • 5.2.2 Dr. Reddy' s Labs (DRL)
    • 5.2.3 Cipla
    • 5.2.4 Sun Pharma
      • 5.2.4.1 Sun Pharma' s Highlights of Performance
    • 5.2.5 Abbott India Ltd. (Knol)
    • 5.2.6 Wockhardt Ltd.
    • 5.2.7 Nicholas Piramal India Ltd.
    • 5.2.8 Lupin Ltd.
  • 5.3 Alembic Ltd.
    • 5.3.1 Alembic and its Business Profile
  • 5.4 Ajanta Pharmaceutical Ltd.
  • 5.5 Strides Arcolab
  • 5.6 Jubiliant Organosys Ltd.
  • 5.7 Biocon Ltd.
  • 5.8 Dabur Pharma Ltd.
• 6. Strategic Groups
• 7. Critical Success Factors (CSF) of the Industry
  • 7.1 Research and Development
  • 7.2 Production
  • 7.3 Marketing, Sales and Distribution
  • 7.4 Operational Efficiency
  • 7.5 Alliances
  • 7.6 Pre-2005 CSFs-Formulations
    • 7.6.1 New Product Launches
    • 7.6.2 Therapeutic Coverage
    • 7.6.3 Sales and Distribution Network
    • 7.6.4 Strong Brands
    • 7.6.5 Exports
    • 7.6.6 Critical Mass
  • 7.7 Pre 2005 CSFs-Bulk Drugs
    • 7.7.1 Low Cost Structure
    • 7.7.2 Internationally Approved Manufacturing Facilities
    • 7.7.3 Speedy Launches
  • 7.8 Post 2005 CSFs-The Most Critical
    • 7.8.1 Basic R&D
    • 7.8.2 Applied Research and Development
    • 7.8.3 Process Research or Reverse Engineering
    • 7.8.4 Analogue or Discovery Research
  • 7.9 Biotechnology Research
    • 7.9.1 Biotech, Bio-Generics and Vaccines
    • 7.9.2 Cost Advantage of Indian Biotech Industry
    • 7.9.3 Challenges Facing the Indian Bio-Generics
    • 7.9.4 Vaccine Manufacturing
    • 7.9.5 Vaccine R&D
  • 7.10 Bringing out a Generic Drug
  • 7.11 New Drug Delivery System (NDDS) Research
  • 7.12 Indian Council of Medical Research-Innovative New Products
  • 7.13 Non-ICMR Vaccines
• 8. Policies and Regulations
  • 8.1 Indian Patents Act (IPA) 1970
  • 8.2 DPCO (Drug Price Control Order) 1970
  • 8.3 GATT and WTO
  • 8.4 Implications of the WTO
    • 8.4.1 On Prices of Drugs
    • 8.4.2 On R&D
  • 8.5 Intellectual Property Rights (IPR)
• 9. Changing Scenario of Product Patent Regime
  • 9.1 Critic' s View
  • 9.2 Price Escalation
  • 9.3 MNC Dominance
  • 9.4 R&D Expenditure
  • 9.5 Technology
  • 9.6 Conclusion
• 10. Laws Pertaining to Manufacture and Sale of Drugs in India
  • 10.1 The Drugs and Cosmetics Act, 1940
  • 10.2 The Pharmacy Act, 1948
    • 10.2.1 State Pharmacy Councils
    • 10.2.2 Registration of Pharmacists
  • 10.3 The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954
  • 10.4 The Narcotic Drugs and Psychotropic Substances Act, 1985
    • 10.4.1 State Pharmacy Councils
    • 10.4.2 Registration of Pharmacists
• 11. Marketing and Distribution in the Pharmaceutical Industry
  • 11.1 In-Clinic Media
  • 11.2 Outdoor Media
  • 11.3 Electronic Media
• 12. The Changing External Environment
• 13. Porters Five Forces Model
  • 13.1 Threat of New Entrants
  • 13.2 Intensity of Competition
  • 13.3 Threat of Substitutes
  • 13.4 Bargaining Power of Buyers
  • 13.5 Bargaining Power of Suppliers
• 14. Future Outlook for the Indian Pharmaceutical Industry
  • 14.1 Government Policy-Update
    • 14.1.1 Budget Proposals, 2005-2006
• 15. Emerging Trends
• 16. India-The Clinical Trial Destination
  • 16.1 Clinical Trials-The India Opportunity
  • 16.2 Clinical Research Organizations (CRO)
  • 16.3 Indian Companies in Collaborative Manufacturing Partnerships with Pharmaceutical Multinationals
  • 16.4 Product Patents will Transform Traditional Medicine
• 17. Risks-Weaknesses and Threats-Faced by Indian Industry
  • 17.1 Global Pharmaceutical Market-India' s Strengths
  • 17.2 Production
  • 17.3 Quality
  • 17.4 Research and Development
  • 17.5 Opportunities for the Future
  • 17.6 Conclusion
• 18. Intellectual Property and Access to Medicines
  • 18.1 Data Exclusivity
  • 18.2 Interpretation of Product Patent Applicability
  • 18.3 Mailbox Applications
  • 18.4 Fears over Price Escalation
  • 18.5 Quality
  • 18.6 Availability
• 19. Evolving Indian Drug Research and Development
  • 19.1 Composition of R&D Expenditure
  • 19.2 A Shift in Focus is the Need of the Hour
  • 19.3 Cost Advantages of Indian Firms
  • 19.4 Achievements of in-House R&D Units Funded by the Indian Department of Scientific and Industrial Research during 2003 to 2004
• 20. Case of a Leading Indian Firm-Ranbaxy Laboratories
  • 20.1 History
  • 20.2 R&D is the Integrating Factor
  • 20.3 Ranbaxy' s Successful Report Card
  • 20.4 Why has Ranbaxy been this Successful?
  • 20.5 Creating Value through Functional Strategies
  • 20.6 Marketing
  • 20.7 Relationship Marketing
  • 20.8 Co-Marketing
  • 20.9 Sales Strength
  • 20.10 Brand Recognition
  • 20.11 Ranbaxy' s Product Strategy
  • 20.12 Ranbaxy R&D Strategy
  • 20.13 Research Strategy
  • 20.14 Ranbaxy' s Human Resources Strategy
  • 20.15 Information Technology
  • 20.16 Revenue Model for a Pharmaceutical Company
• 21. Strategic Options for Pharmaceutical Firms
  • 21.1 Invest in Research and Development Capabilities
  • 21.2 Grow a Wide Product Portfolio
    • 21.2.1 Growth through Mergers and Acquisitions
    • 21.2.2 Growth through Brand Acquisition
    • 21.2.3 Growth through Licensing Agreements
  • 21.3 Remain a Generics Player
• 22. How to Build Sustainable Competitive Advantage
  • 22.1 Product Portfolio Management
  • 22.2 Integrated Healthcare Company
  • 22.3 Distribution
  • 22.4 Disease Management/Service Provider
  • 22.5 Clinical Test Centers
  • 22.6 Healthcare Funding Systems
  • 22.7 Re-Engineering
  • 22.8 Outsourcing Services

• Appendix

• 1. Requirements and Guidelines for Permission to Import and/or Manufacture of New Drugs for Sale or to Undertake Clinical Trials
  • 1.1 Application for Permission
• 2. Clinical Trial
  • 2.1 Approval for Clinical Trial
  • 2.2 Responsibilities of Sponsor
  • 2.3 Responsibilities of the Investigator(s)
  • 2.4 Informed Consent
  • 2.5 Responsibilities of the Ethics Committee
  • 2.6 Human Pharmacology (Phase I)
  • 2.7 Therapeutic Exploratory Trials (Phase II)
  • 2.8 Therapeutic Confirmatory Trials (Phase III)
  • 2.9 Post-Marketing Trials (Phase IV)
• 3. Studies in Special Populations
  • 3.1 Geriatrics
  • 3.2 Pediatrics
  • 3.3 Pregnant or Nursing Women
  • 3.4 Post-Marketing Surveillance
  • 3.5 Special Studies: Bioavailability/Bioequivalence Studies
• 4. Data to be Submitted Along with the Application to Conduct Clinical Trials/Import/Manufacture of New Drugs for Marketing in India
• 5. Data Required to be Submitted by an Applicant for Grant of Permission to Import and/or Manufacture a New Drug Already Approved in India
• 6. Structure, Contents and Format for Clinical Study Reports
• 7. Animal Toxicology (Non-Clinical Toxicity Studies)
  • 7.1 General Principles
    • 7.1.1 Systemic Toxicity Studies
      • 7.1.1.1 Single-Dose Toxicity Studies
      • 7.1.1.2 Repeated-Dose Systemic Toxicity Studies
    • 7.1.2 Male Fertility Study
    • 7.1.3 Female Reproduction and Developmental Toxicity Studies
      • 7.1.3.1 Female Fertility Study (Segment I)
      • 7.1.3.2 Teratogenicity Study (Segment II)
      • 7.1.3.3 Prenatal Study (Segment III)
    • 7.1.4 Local Toxicity
    • 7.1.5 Allergenicity/Hypersensitivity
    • 7.1.6 Genotoxicity
    • 7.1.7 Carcinogenicity
• 8. Non-Clinical Toxicity Testing and Safety Evaluation Data of an Ind Needed for the Conduct of Different Phases of Clinical Trials
  • 8.1 For Phase I Clinical Trials
  • 8.2 For Phase II Clinical Trials
  • 8.3 In vivo Genotoxicity Tests
  • 8.4 For Phase III Clinical Trials
  • 8.5 For Phase IV Clinical Trials
• 9. Animal Pharmacology
  • 9.1 General Principles
    • 9.1.1 Specific Pharmacological Actions
    • 9.1.2 General Pharmacological Actions
      • 9.1.2.1 Essential Safety Pharmacology
    • 9.1.3 Follow-up and Supplemental Safety Pharmacology Studies
      • 9.1.3.1 Follow-up Studies for Essential Safety Pharmacology
      • 9.1.3.2 Supplemental Safety Pharmacology Studies
    • 9.1.4 Conditions under which Safety Pharmacology Studies are not Necessary
    • 9.1.5 Timing of Safety Pharmacology Studies in Relation to Clinical Development
      • 9.1.5.1 Prior to First Administration in Humans
      • 9.1.5.2 During Clinical Development
      • 9.1.5.3 Before Applying for Marketing Approval
    • 9.1.6 Application of Good Laboratory Practices (GLP)
• 10. Informed Consent
  • 10.1 Checklist for Study Subject' s Informed Consent Documents
    • 10.1.1 Essential Elements
    • 10.1.2 Additional Elements, which may be Required
  • 10.2 Format of Informed Consent Form for Subjects Participating in a Clinical Trial
• 11. Fixed Dose Combinations (FDCs)
• 12. Undertaking by the Investigator
• 13. Ethics Committee
  • 13.1 Number of Persons
  • 13.2 Format for Approval of Ethics Committee
• 14. Stability Testing of New Drugs
• 15. Stability Testing of New Drug Substances and Formulations
• 16. Contents of the Proposed Protocol for Conducting Clinical Trials
  • 16.1 Title Page
  • 16.2 Table of Contents
• 17. Data Elements for Reporting Serious Adverse Events Occurring in a Clinical Trial

INDEX OF FIGURES

• Figure 2.1: Region-wise Indian Exports of Pharmaceutical Products, 2004-2006
• Figure 3.1: New Drug Approvals, 2002-2006
• Figure 4.1: Global Pharmaceuticals Market Segmentation by Value, 2006
• Figure 4.2: Global Pharmaceuticals Market Value Forecast, 2006-2011
• Figure 5.1: Overall Indexed Clinical Trial Costs
• Figure 6.1: Strategic Group Mapping
• Figure 13.1: Porter' s Five Forces Model Applied
• Figure 20.1: Value Chain of Ranbaxy
• Figure 21.1: Strategic Options Available for Pharmaceutical Firms

INDEX OF TABLES

• Table 1.1: Annual Drug Expenditure Per Capita in Selected Countries
• Table 1.2: Comparative Prices of Some Products in U.S. and India
• Table 1.3: Number of Patent Applications in Top Ten Countries
• Table 2.1: India Projected to be the Tenth Largest Market, 2005 and 2015
• Table 2.2: Incremental Growth, 2005-2015
• Table 2.3: Overseas Investments by Indian Companies
• Table 2.4: Acquisitions in CRAMS Market and Joint Ventures, 2006-2007
• Table 2.5: New Investments, 2007
• Table 2.6: Contract Research Deals, 2007
• Table 2.7: Key Contract Research Organizations in India
• Table 2.8: India' s Major Pharma Exports to Various Destinations, 2005-2006
• Table 2.9: India' s Pharmaceutical Industry
• Table 2.10: Major Therapeutic Segments
• Table 2.11: List of Patent Expiry Drugs
• Table 2.12: List of Drugs, Which are Going Off Patent
• Table 2.13: India' s Top Ten Pharmaceutical Company Sales
• Table 2.14: Principal Products of India' s Leading Drug Manufacturers
• Table 3.1: Budget Proposals Benefiting Pharmaceutical Industry
• Table 3.2: Budget Proposals and the Immediate Beneficiaries of Indian Pharma Companies
• Table 3.3: Indian Pharmaceutical Market, 2000-2006
• Table 3.4: India' s Pharmaceutical Imports, 1999-2005
• Table 3.5: India' s Pharmaceutical Imports by Product Group, 1999-2005
• Table 3.6: India' s Pharmaceutical Imports from Top-Seven Countries, 2002-2006
• Table 3.7: India Projected to be the Tenth Largest Market by 2015
• Table 3.8: India' s Pharmaceutical Market will be the Third Largest During 2005-2015
• Table 3.9: Present Core Competence of Indian Pharmaceutical Industry
• Table 3.10: Competitive and Cooperative Strategies Adopted by Indian Pharma Firms, 2006
• Table 3.11: Foreign Resource Mobilization by Indian Companies, 1994-2006
• Table 3.12: Indigenous Modern Vaccine Development in India
• Table 3.13: List of Selected Indian Biotechnology Companies
• Table 3.14: India' s Top 20 Biotechnology Companies' Sales, 2003-2005
• Table 4.1: Guiding Stars of Indian Pharmaceutical Industry, 2006
• Table 4.2: Data on Production of Bulk Drugs of Selected Companies in the Organized Sector
• Table 4.3: Strategic Options for Indian Companies
• Table 4.4: Strengths and Weaknesses of India' s Pharmaceutical Industry
• Table 4.5: Value of Production of Bulk Drugs and Formulations, 2000-2005
• Table 4.6: Value of Imports and Exports of Bulk Drugs and Formulations, 2000-2006
• Table 4.7: India' s Pharmaceutical Exports, 1999-2006
• Table 4.8: India' s Pharmaceutical Exports to Top-15 Countries, 2003-2005
• Table 4.9: Indian Pharmaceutical Exports by Commodity, 2002-2006
• Table 4.10: Top 20 Suppliers for UNICEF
• Table 4.11: Bulk Drug and Formulations
• Table 4.12: Global Pharmaceuticals Market Segmentation, 2006
• Table 4.13: Global Pharmaceuticals Market Value, 2002-2006
• Table 4.14: Global Pharmaceuticals Market Value Forecast, 2006-2011
• Table 4.15: Leading Therapeutic Segments
• Table 4.16: Market Share of Major Therapeutic Segments
• Table 4.17: Leading Brands in Each Category
• Table 4.18: Market Growth Rates, 2003 and 2004
• Table 4.19: Marketing Tie-ups
• Table 5.1: Key Players and Their Characteristics
• Table 5.2: Major Players in Terms of Market Capitalization, 2005
• Table 5.3: India' s Top Seven Drug Companies in 2008
• Table 5.4: Likely Winners Among Contract Research Vendors in India
• Table 5.5: Selected CRAMS Products and Deals in India
• Table 5.6: "Advantage India" in Outsourcing
• Table 5.7: Pre-Clinical and Clinical Development in India
• Table 5.8: Clinical Trial Approval Time in India
• Table 5.9: Number of R&D Vendors in Bangalore, Mumbai and Hyderabad
• Table 5.10: CRO Landscape in India
• Table 5.11: International Quality Standards in Indian CROs
• Table 5.12: Multimillion Dollar R&D Deals with Multiple Vendors
• Table 5.13: U.S. FDA-Approved Facilities in Countries Outside the U.S.
• Table 5.14: Pfizer India-Capacity Data
• Table 5.15: Pfizer India-Raw Materials Data
• Table 5.16: Top 15 Products of Pfizer India, 2007
• Table 5.17: The Composition of Aventis' R&D Portfolio
• Table 5.18: Excerpt of Novartis Pharma' s Clinical Pipeline, 2007
• Table 5.19: Novartis India Capacity Data
• Table 5.20: Novartis India Raw Material Data
• Table 5.21: List of Subsidiaries and Joint Ventures of Ranbaxy Laboratories
• Table 5.22: Ranbaxy' s Key Financials, 2005-2007
• Table 5.23: Ranbaxy Price History, 2005
• Table 5.24: Ranbaxy Interim History
• Table 5.25: Ranbaxy-Capacity Data
• Table 5.26: Ranbaxy-Raw Materials Data
• Table 5.27: Ranbaxy' s Foreign Acquisitions
• Table 5.28: Dr. Reddy' s Labs Capacity Data
• Table 5.29: Dr. Reddy' s Labs Raw Materials Data
• Table 5.30: Cipla-Capacity Data
• Table 5.31: Cipla-Raw Materials Data
• Table 5.32: List of Subsidiaries of Sun Pharma
• Table 5.33: New Products from Sun Pharma
• Table 5.34: Sun Pharma-API Products List
• Table 5.35: Sun Pharma-Raw Materials Data
• Table 5.36: Abbott India Ltd. (Knol)-Capacity Data
• Table 5.37: Abbott India Ltd. (Knol)-Raw Materials Data
• Table 5.38: The Acquisition History of Wockhardt
• Table 5.39: Wockhardt' s 15 Years of Transformation
• Table 5.40: Wockhardt' s Performance Snapshot-CAGR (Last 15 Years)
• Table 5.41: Wockhardt' s Comprehensive Manufacturing Capabilities
• Table 5.42: Wockhardt' s R&D Activity
• Table 5.43: Wockhardt' s Focus on Major Therapeutic Areas, 2006
• Table 5.44: Wockhardt' s Strengths and Weaknesses
• Table 5.45: Wockhardt' s Business Highlights
• Table 5.46: Wockhardt' s R&D Activity
• Table 5.47: Wockhardt' s Ramp-up in U.S.
• Table 5.48: Wockhardt-Capacity Data
• Table 5.49: Wockhardt-Raw Material Data
• Table 5.50: List of Subsidiaries of Wockhardt Ltd.
• Table 5.51: Nicholas Piramal' s Foreign and Domestic Acquisitions
• Table 5.52: Nicholas Piramal' s CRAMS Pipeline, 2008
• Table 5.53: Highlights of Lupin Pharmaceutical
• Table 5.54: Lupin' s Globally Accredited Facilities
• Table 5.55: Lupin' s U.S./E.U. Product Development
• Table 5.56: Top-Ten Brands of Alembic in the Domestic Market
• Table 5.57: Industry Ranking of Alembic Products
• Table 5.58: The Ten-Crore Plus Brands of Alembic
• Table 5.59: High Growth Brands of Alembic
• Table 5.60: Key Markets of Alembic, 2008
• Table 5.61: Alembic' s New Product Launches, 2005-2006
• Table 5.62: New APIs Under Development in Alembic
• Table 5.63: Ajanta Pharma' s Performance Highlights
• Table 5.64: Strides Arcolab' s Expenditure on R&D, 2005 and 2006
• Table 5.65: Strides Arcolab' s Subsidiaries and Joint Ventures
• Table 6.1: India' s Pharmaceutical Firms by Size, Sales, Function, Exports and R&D Capabilities
• Table 7.1: Government Run Research Organizations and Industry Collaborations
• Table 7.2: Number of Brand Acquisitions
• Table 7.3: India' s Pharmaceutical R&D Expenditures, 2000-2006
• Table 7.4: R&D Spending by Selected Indian Pharmaceutical Firms
• Table 9.1: Indian Patent Regime in Place
• Table 9.2: India' s Pharmaceutical R&D Expenditures, 2000-2006
• Table 10.1: Drugs Control Administration by the Central Drug Standard Control Organization under the Aegis of Directorate General of Health Services of the Ministry of Health and Family Welfare of the Government of India
• Table 11.1: List of Drugs Approved During 1999 to 2004
• Table 11.2: New Drugs Approved from August 2004 to February 2005
• Table 11.3: List of Drugs Prohibited for Manufacture and Sale through Gazette Notifications under Section 26A of Drugs and Cosmetics Act 1940 by the Ministry of Health and Family Welfare
• Table 11.4: Other Drugs Prohibited for Manufacture, Sale and Distribution
• Table 16.1: Projected Growth of Indian Clinical Research Industry, 2010
• Table 19.1: Chemical and Allied Industries
• Table 20.1: Ranbaxy' s IT Initiatives
• Table 21.1: Typical Price Drops after a Drug Goes Off Patent
• Table 22.1: Some of the Select Contract Manufacturing Deals in India
• Table A7.1: Animal Toxicity Requirements for Clinical Trials and Marketing of a New Drug
• Table A7.2: Local Toxicity Studies
• Table A7.3: Special Toxicity Studies
• Table A7.4: Number of Animals Required for Repeated-Dose Toxicity Studies
• Table A7.5: Laboratory Parameters to be Included in Toxicity Studies
• Table A7.6: Urinalysis Parameters
• Table A7.7: Blood Biochemical Parameters
• Table A7.8: Gross and Microscopic Pathology
• Table A10.1: Informed Consent Form to Participate in a Clinical Trial
• Table A15.1: Study Conditions for Drug Substances and Formulations Intended to be Stored under General Conditions
• Table A15.2: Study Conditions for Drug Substances and Formulations Intended to be Stored in a Refrigerator
• Table A15.3: Study Conditions for Drug Substances and Formulations Intended for Storage
• Table A17.1: Contact Information-Major Indian Pharma Industries
• Table A17.2: Contact Information-Pharmaceutical Research
• Table A17.3: Contact Information-Biotechnology, Bioinformatics, Clinical Trials

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