Updated, expanded and now also available on CD-ROM

The successful collaboration between CMR International and Scrip Reports that produced the best-selling 1997 R&D Compendium has been repeated. This prestigious compendium has been extensively updated and the amount of information provided increased, to include brand new data from CMR surveys and PharmaProjects on R&D activities during 1998.

With over 300 tables, charts and graphs and supplemented by 500+ pages of commentary and analysis, the compendium is now fully formatted on CD-ROM to ensure that you can identify, manipulate and retrieve this vast array of information quickly and easily. The Pharmaceutical R&D Compendium is the definitive source of R&D information.

Subject coverage includes: R&D strategies and investment, R&D projects by therapeutic class, company development portfolios, key benchmarks, development times, preclinical projects, NMEs in development, marketed medicines.

This compendium will help you to: save hours in research time; predict future trends in your markets; establish benchmarks for industry performance; develop new strategies to gain competitive advantage; evaluate product investment potential; and position your product to maximum benefit.

PUBLICATION: JANUARY 1999
REF: BS998E
PAGES: 800
PRICE: £1,495/$2,995/¥349,500

CONTENTS

VOLUME 1

SECTION 1 - R&D INVESTMENT AND SALES
1.1: Introduction
1.2: Estimates of the Cost of Bringing an NME to Market
1.3: US$600 Million to get an NCE to Market
1.4: Trends in R&D Expenditure and Sales Within the Pharmaceutical Industry (1982-2001)
1.5: Global R&D Expenditure (1989-1998)
1.6: Trends in Worldwide Pharmaceutical R&D Expenditure (1989-1998)
1.7: Pharmaceutical R&D Expenditure in the USA (1981-1998)
1.8: Pharmaceutical R&D Expenditure in Japan (1982-1996)
1.9: Pharmaceutical R&D Expenditure in Europe (1981-1997)
1.10: Pharmaceutical R&D Expenditure in the UK (including capital; 1988-1997)
1.11: Functional Allocation of Worldwide R&D Expenditure (1995-1997)
1.12: Functional Allocation of R&D Expenditure in the USA (1991-1996)
1.13: Proportion of UK Pharmaceutical R&D Expenditure on Discovery Research, Development Research and Capital (1982-1997)
1.14: Allocation of R&D Expenditure in the USA by Therapeutic Class (1992-1996)
1.15: Approximate Cost of Components of Regulatory Toxicology for the Development of a Chronic Treatment for a Single Route of Administration
1.16: Pharmaceutical R&D Expenditure by Leading Companies (1996-1998)
1.17: R&D Expenditure by Leading Biotech Companies (1995-1997)
1.18: Total Revenue, R&D Expenditure and Profit and Loss for 372 Publicly Traded Biotech Companies in 1997
1.19: Ratio of R&D Expenditure to Sales (1996-1998)
1.20: World Pharmaceutical Market in 1997 and 2001
1.21: Pharmaceutical Sales (1997) by Therapeutic Class
1.22: Pharmaceutical Sales (1995-2000) and Contribution of New Drugs in Each Timeframe
1.23: Estimates of Proportion of Pharmaceutical Sales Vulnerable to Patent Expiry
1.24: Number of Pharmaceutical Drugs Losing Patent Protection and Estimated Revenue Loss (1995-2005)
1.25: 1996 and 2000 Pharmaceutical Sales: Change in Uniqueness
1.26: Pharmaceutical Sales by Leading Companies (1996-2000)
1.27: Healthcare Spending as Percent of GDP for Selected Countries
1.28: The Impact of New Technologies on R&D Productivity and Costs
1.29: Effect of Company Mergers on Economic Returns in the Pharmaceutical Industry
1.30: Pharmaceutical R&D Employees in Europe (1986-1997)
1.31: Employment in the Pharmaceutical Industry in Europe and the USA (1990-1997)
1.32: Domestic US Scientific and Professional R&D Personnel by R&D Function and Degree of Education in Research-based Pharmaceutical Companies

SECTION 2 - OUTSOURCING STRATEGIES
2.1: Introduction
2.2: Growth of the Top 20 CROs (1994-1997)
2.3: Number of New CROs in Europe and the USA (1981-1997)
2.4: Areas of Therapeutic Experience of European and US CROs
2.5: Growth of European CROs by Country (1977-1997)
2.6: Estimates of Size of Outsourcing Markets (1997-2002)
2.7: Company-wide Policies for Outsourcing in (A) All Respondents and (B) Respondents Supplying Data For All Four Functional Areas
2.8: Centralised Contracting Groups for Outsourcing in (A) All Respondents and (B) Respondents Supplying Data For All Four Functional Areas
2.9: Involvement of Project Managers/Project Team and Functional Managers in the Decision to Outsource and Responsibility for Monitoring Quality
2.10: Proportion of Work Outsourced in Each Functional Area in 1997
2.11: Geographical Breakdown of Outsourced Work in 1997
2.12: Proportion of Companies Predicting an Increase in the Proportion of Work Outsourced in Next Two and Five Years
2.13: How the Actual Cost of Outsourcing Compares with the Estimated Cost
2.14: The Use of Penalty and Bonus Clauses in Outsourcing Contracts
2.15: Competition Between Internal Groups and CROs
2.16: Outsourcing of Complete Development Programmes

SECTION 3 - R&D STRATEGIES AND CULTURE
3.1: Introduction
3.2: Endpoint Used for High Dose Selection in Carcinogenicity Studies in 1995 and 1996
3.3 Reasons for Use of the MTD as the Endpoint for High Dose Selection in Carcinogenicity Studies in 1996
3.4: Selection of Species for Repeat-dose Studies for the Non-clinical Safety Evaluation of Biotech Products
3.5: Reasons for Conduct of Reproduction Toxicity Studies for the Non-clinical Safety Evaluation of Biotech Products
3.6: Reasons for Conduct of Genotoxicity Studies for the Non-clinical Safety Evaluation of Biotech Products
3.7: Use of Different Test Systems or Models for the Non-clinical Safety Evaluation of Biotech Products
3.8: Reasons for Involvement with New Short- or Medium-term in vivo Rodent Models for Carcinogenicity Testing
3.9: Company Experience with New Short- or Medium-term in vivo Rodent Models for Carcinogenicity Testing
3.10: Company Strategy for the Assessment of Carcinogenic Potential for Regulatory Submissions
3.11: Approaches Used for Portfolio Management at Key Decision Points in Early and Late Development
3.12: Information Used to Support Key Decisions in Early and Late Development
3.13: Cultural Profiles of Five UK Pharmaceutical R&D Organisations
3.14: Comparison of the Innovative Environment in Pharmaceutical and Other Companies
3.15: Opinions of Directors/Senior Managers and Other Staff on Culture in Five UK Pharmaceutical R&D Organisations

VOLUME 2

SECTION 4 - NMES IN DEVELOPMENT
4.1: Introduction
4.2: Attrition in One UK-based International Company in 1995
4.3: Probability of Success in Each Phase: Analysis of 113 NME Projects in a European-based Leading Company (1976-1996)
4.4: Attrition in 17 Japanese Companies (1992-1996)
4.5: Attrition Data (Probability of Success) Used by 27 Companies in 1998
4.6: Percentage of NASs for which Development was Terminated in 1997 by 40 Companies
4.7: NASs by Development Phase at the End of 1997 for 40 Companies
4.8: NMEs by Development Phase at the End of 1995, 1996 and 1997 for Leading Companies
4.9: Therapeutic Profile of the NAS Development Pipeline at the End of 1997 for 40 Companies
4.10: Percentage of NASs by Therapeutic Class in the Development Pipeline at the End of 1997 for 40 Companies
4.11: Percentage of NMEs by Therapeutic Class Marketed in the Last Decade and in Development at the End of 1997 by 40 Companies
4.12: Number of Top 20 Companies Designating Selected Therapeutic Classes as Core or Additional Areas of Research
4.13: Origin of NASs at Each Phase of Development at the End of 1996 and 1997 for 29 Companies
4.14: Biotech NASs in the Development Pipeline at the End of 1997 for 40 Companies
4.15: Development Phase in 1997 of those NASs in the Development Pipeline in 1996 for 29 Companies
4.16: Compound Library Size and Derivation (1994-2000)
4.17: HTS Screening Capacity and Number of Targets Screened by HTS
4.18: Genomics as a Growing Source of Therapeutic Targets

SECTION 5 - PRECLINICAL PROJECTS
5.1: Introduction
5.2a-c: Ratio of Preclinical to Total Projects by Therapeutic Class, 1998
5.3: Breakdown of Leading Companies' Preclinical Portfolios by Therapeutic Class, 1995-1998
5.3: Breakdown of Leading Companies' Preclinical Portfolios by Therapeutic Class, 1995-1998

SECTION 6 - BIOTECHNOLOGY PROJECTS
6.1: Introduction
6.2: Number of Biotech Projects in Development (1995-1998)
6.3: Number of Biotech Projects by Type, 1998
6.4a-b: Number of Biotech Projects in Development by Therapeutic Class (1995-1998)
6.5a-e: Number of Biotech Projects in the Leading Companies' Portfolios, 1998

SECTION 7 - PROJECTS BY THERAPEUTIC CLASS
7.1: Introduction
7.1a: Number of Projects in R&D (1995-1998)
7.1b: The Top 25 Therapeutic Groups by Number of Compounds in R&D (1998)
7.1c: The Top 20 Pharmacological Strategies by Number of Compounds in R&D (1998)
7.1d: Therapeutic Breakdown of the Pharmaprojects Database
7.2: Number of Alimentary/Metabolic Projects in Development (1995-1998)
7.2a: Number of Antidiabetic Projects in Development (1995-1998)
7.2b: Number of Anti-ulcer Projects in Development (1995-1998)
7.2c: Number of Gastrokinetic Projects in Development (1995-1998)
7.2d: Major Companies in the Development of Alimentary/Metabolic Projects (1997-1998)
7.3: Number of Blood and Clotting Projects in Development (1995-1998)
7.3a: Number of Anti/clotting Projects in Development (1995-1998)
7.3b: Number of Anti-anaemia Projects in Development (1995-1998)
7.3c: Number of Septic Shock Projects in Development (1995-1998)
7.3d: Major Companies in the Development of Blood and Clotting Projects (1997-1998)
7.4: Number of Cardiovascular Projects in Development (1995-1998)
7.4a: Number of Cardiac Projects in Development (1995-1998)
7.4b: Number of Antihypertensive Projects in Development (1995-1998)
7.4c: Number of Hypolipaemic Projects in Development (1995-1998)
7.4d: Major Companies in the Development of Cardiovascular Projects (1997-1998)
7.5: Number of Dermatological Projects in Development (1995-1998)
7.5a: Number of Wound Healing Projects in Development (1995-1998)
7.5b: Number of Antipruritic Projects in Development (1995-1998)
7.5c: Number of Antipsoriasis Projects in Development (1995-1998)
7.5d: Major Companies in the Development of Dermatological Projects (1997-1998)
7.6: Number of Genito-urinary Projects in Development (1995-1998)
7.6a: Number of Fertility, Contraceptive and Natal Projects in Development (1995-1998)
7.6b: Number of Menstrual and Menopausal Projects in Development (1995-1998)
7.6c: Number of Urological and Prostate Disorders Projects in Development (1995-1998)
7.6d: Major Companies in the Development of Genito-urinary Projects (1997-1998)
7.7: Number of Hormonal Projects in Development (1995-1998)
7.7a: Major Companies in the Development of Hormonal Projects (1997-1998)
7.8: Number of Immunological Projects in Development (1995-1998)
7.8a: Number of Immunostimulant Projects in Development (1995-1998)
7.8b: Number of Immunosuppressant Projects in Development (1995-1998)
7.8c: Number of Cytokine Projects in Development (1995-1998)
7.8d: Major Companies in the Development of Immunological Projects (1997-1998)
7.9: Number of Anti-infective/ Antiparasitic Projects in Development (1995-1998)
7.9a: Number of Antibiotic/Antibacterial/ Antimycobacterial Projects in Development (1995-1998)
7.9b: Number of Antifungal Projects in Development (1995-1998)
7.9c: Number of Anti-HIV Projects in Development (1995-1998)
7.9d: Number of Antiviral (non-HIV) Projects in Development (1995-1998)
7.9e: Number of Antiparasitic Projects in Development (1995-1998)
7.9f: Number of Vaccine and Other Anti-infective Immunological Projects in Development (1995-1998)
7.9g: Major Companies in the Development of Anti-infective Projects (1997-1998)
7.10: Number of Anticancer Projects in Development (1995-1998)
7.10a: Number of Classical Anticancer Projects in Development (1995-1998)
7.10b: Number of Endogenous Anticancer Projects in Development (1995-1998)
7.10c: Number of Cancer Therapy Projects in Development (1995-1998)
7.10d: Major Companies in the Development of Anticancer Projects (1997-1998)
7.11: Number of Musculoskeletal Projects in Development (1995-1998)
7.11a: Number of Anti-inflammatory/Anti-arthritic Projects in Development (1995-1998)
7.11b: Number of Osteoporosis Projects in Development (1995-1998)
7.11c: Major Companies in the Development of Musculoskeletal Projects (1997-1998)
1. Number of Neurological Projects in Development (1995-1998)
7.12a: Number of Antinociceptive (Pain) Projects in Development (1995-1998)
7.12b: Number of Motor Neurone Disorder Projects in Development (1995-1998)
7.12c: Number of Personality Disorder and Dependence Treatment Projects in Development (1995-1998)
7.12d: Number of Central Stimulant Projects in Development (1995-1998)
7.12e: Number of Antimigraine Projects in Development (1995-1998)
7.12f: Number of Neuroprotective Projects in Development (1995-1998)
7.12g: Major Companies in the Development of Neurological Projects (1997-1998)
7.13: Number of Respiratory Projects in Development (1995-1998)
7.13a: Number of Lung Disorder and Cough Projects in Development (1995-1998)
7.13b: Number of Anti-asthma Projects in Development (1995-1998)
7.13c: Number of Anti-allergy Projects in Development (1995-1998)
7.13d: Major Companies in the Development of Respiratory Projects (1997-1998)
7.14: Number of Sensory Projects in Development (1995-1998)
7.14a: Number of Ophthalmic Projects in Development (1995-1998)
7.14b: Major Companies in the Development of Sensory Projects (1997-1998)
7:15: Number of Formulatory Projects in Development (1995-1998)
7.15a: Major Companies in the Development of Formulation Projects (1997-1998)

VOLUME 3

SECTION 8 - LICENSING ACTIVITIES
8.1: Introduction
8.2: Number of Compounds Licensed-out by Development Stage (1996-1998)
8.3a-c: Number of Compounds Licensed-out by Therapeutic Class (1996-1998)
8.4a-e: Number of Licensed-in and Self-originated Projects in the Leading Companies' Development Portfolios, 1998

SECTION 9 - COMPANY DEVELOPMENT PORTFOLIOS
9.1: Introduction
9.1a: Major Companies Ranked by Number of Pharmaceutical Compounds in R&D (1998)
9.2: Ciba/Sandoz/Novartis' Development Portfolio (1996-1998)
9.2a: Ciba/Sandoz/Novartis' Development Portfolio by Therapeutic Class (1996-1998)
9.3: Hoechst Marion Roussel's Development Portfolio (1995-1998)
9.3a: Hoechst/Roussel-Uclaf/Marion Merrell Dow/Hoechst Marion Roussel's Development Portfolio by Therapeutic Class (1995-1998)
9.4: Merck & Co's Development Portfolio (1995-1998)
9.4a: Merck & Co's Development Portfolio by Therapeutic Class (1995-1998)
9.5: Pharmacia & Upjohn's Development Portfolio (1995-1998)
9.5a: Pharmacia & Upjohn's Development Portfolio by Therapeutic Class (1995-1998)
9.6: Glaxo Wellcome's Development Portfolio (1995-1998)
9.6a: Glaxo Wellcome's Development Portfolio by Therapeutic Class (1995-1998)
9.7: SmithKline Beecham's Development Portfolio (1995-1998)
9.7a: SmithKline Beecham's Development Portfolio by Therapeutic Class (1995-1998)
9.8: Bristol-Myers Squibb's Development Portfolio (1995-1998)
9.8a: Bristol-Myers Squibb's Development Portfolio by Therapeutic Class (1995-1998)
9.9: Warner-Lambert's Development Portfolio (1995-1998)
9.9a: Warner-Lambert's Development Portfolio by Therapeutic Class (1995-1998)
9.10: Roche's Development Portfolio (1995-1998)
9.10a: Roche's Development Portfolio by Therapeutic Class (1995-1998)
9.11: American Home Products' Development Portfolio (1995-1998)
9.11a: American Home Products' Development Portfolio by Therapeutic Class (1995-1998)
9.12: Eli Lilly's Development Portfolio (1995-1998)
9.12a: Eli Lilly's Development Portfolio by Therapeutic Class (1995-1998)
9.13: Rhône-Poulenc Rorer's Development Portfolio (1995-1998)
9.13a: Rhône-Poulenc Rorer's Development Portfolio by Therapeutic Class (1995-1998)
9.14: Johnson & Johnson's Development Portfolio (1995-1998)
9.14a: Johnson & Johnson's Development Portfolio by Therapeutic Class (1995-1998)
9.15: Schering-Plough's Development Portfolio (1995-1998)
9.15a: Schering-Plough's Development Portfolio by Therapeutic Class (1995-1998)
9.16: Schering AG's Development Portfolio (1995-1998)
9.16a: Schering AG's Development Portfolio by Therapeutic Class (1995-1998)
9.17: Yamanouchi's Development Portfolio (1995-1998)
9.17a: Yamanouchi's Development Portfolio by Therapeutic Class (1995-1998)
9.18: Astra's Development Portfolio (1995-1998)
9.18a: Astra's Development Portfolio by Therapeutic Class (1995-1998)
9.19: Abbott's Development Portfolio (1995-1998)
9.19a: Abbott's Development Portfolio by Therapeutic Class (1995-1998)
9.20: Pfizer's Development Portfolio (1995-1998)
9.20a: Pfizer's Development Portfolio by Therapeutic Class (1995-1998)
9.21: Sanofi's Development Portfolio (1995-1998)
9.21a: Sanofi's Development Portfolio by Therapeutic Class (1995-1998)
9.22: Boehringer Ingelheim's Development Portfolio (1995-1998)
9.22a: Boehringer Ingelheim's Development Portfolio by Therapeutic Class (1995-1998)
9.23: Knoll's Development Portfolio (1995-1998)
9.23a: Knoll's Development Portfolio by Therapeutic Class (1995-1998)
9.24: Elan's Development Portfolio (1995-1998)
9.24a: Elan's Development Portfolio by Therapeutic Class (1995-1998)
9.25: Chiron's Development Portfolio (1995-1998)
9.25a: Chiron's Development Portfolio by Therapeutic Class (1995-1998)
9.26: Zeneca's Development Portfolio (1995-1998)
9.26a: Zeneca's Development Portfolio by Therapeutic Class (1995-1998)
9.27: Takeda's Development Portfolio (1995-1998)
9.27a: Takeda's Development Portfolio by Therapeutic Class (1995-1998)
9.28: Merck KGaA's Development Portfolio (1995-1998)
9.28a: Merck KGaA's Development Portfolio by Therapeutic Class (1995-1998)
9.29: Novo Nordisk's Development Portfolio (1995-1998)
9.29a: Novo Nordisk's Development Portfolio by Therapeutic Class (1995-1998)
9.30: BioChem Pharma's Development Portfolio (1995-1998)
9.30a: BioChem Pharma's Development Portfolio by Therapeutic Class (1995-1998)
9.31: Bayer's Development Portfolio (1995-1998)
9.31a: Bayer's Development Portfolio by Therapeutic Class (1995-1998)

SECTION 10 - KEY BENCHMARKS
10.1: Introduction
10.2: CMR International Benchmarking Programme: Key Milestones for Cycle Times
10.3: CMR International Benchmarking Programme: Median Duration of Key Intervals for NCEs and Biotech Compounds
10.4: CMR International Benchmarking Programme: Median Duration of Key Intervals for NMEs Intended for Oral or Intravenous Administration
10.5: CMR International Benchmarking Programme: Median Duration of Key Intervals for NMEs in Development for Different Treatment Durations
10.6: CMR International Benchmarking Programme: Median Duration of Key Intervals for NMEs in Different Therapeutic Classes
10.7: CMR International Benchmarking Programme: Median Duration of Key Intervals for NMEs in Development by Different Types of Company
10.8: CMR International Benchmarking Programme: Hypothetical Cycle Time for NMEs in Development in 1994-1995
10.9: CMR International Benchmarking Programme: Key Timepoints for Clinical Studies
10.10: CMR International Benchmarking Programme: Median Duration of Key Intervals in Clinical Trials of NMEs in Development for Different Treatment Durations
10.11: CMR International Benchmarking Programme: Median Duration of Key Intervals in Different Sized Clinical Trials of NMEs
10.12: CMR International Benchmarking Programme: Median Duration of Key Intervals in Clinical Trials of NMEs Conducted at Different Numbers of Sites
10.13: CMR International Benchmarking Programme: Median Duration of Clinical Trials of NMEs in Different Therapeutic Classes
10.14: CMR International Benchmarking Programme: Hypothetical Cycle Time for Clinical Studies Completed in 1995

VOLUME 4

SECTION 11 - MARKETED MEDICINES
11.1: Introduction
11.2: NMEs Introduced Onto a Twenty-country Market (1970-1998)
11.3: Trends in the Number of NMEs Introduced Onto a Twenty-country Market (1980-1997)
11.4: Biotech Products Introduced Onto a Twenty-country Market (1982-1997)
11.5: Companies Responsible for Originating and First Marketing Biotech Products Onto a Twenty-country Market (1982-1998)
11.6: Percentage of Total NMEs Launched Onto a Twenty-country Market by Therapeutic Class (1987-1998)
11.7: Distribution Among the Largest Seven Therapeutic Classes of NMEs First Marketed by the Leading and Other Companies (1987-1998)
11.8: Nervous System NMEs First Marketed Onto a Twenty-country Market (1970-1998)
11.9: Cardiovascular NMEs First Marketed Onto a Twenty-country Market (1970-1998)
11.10: Nationality of Companies Originating and Marketing NMEs Reaching Global Status (1984-1998)
11.11: Number of NMEs First Marketed Onto a Twenty-country Market (1984-1998) by European, US and Japanese Marketing Groups and the Number Reaching Global Status by September 1998
11.12: Proportion of NMEs Reaching Global Status by September 1998 in Each Therapeutic Class (1984-1998)
11.13: First Market and Fifth Global Market for NMEs First Marketed (1984-1998) Attaining Global Status by September 1998
11.14: NMEs First Launched Worldwide (1988-1998)
11.14a: New Chemical Entities and Biologicals First Launched Onto the World Market in 1991
11.14b: New Chemical Entities and Biologicals First Launched Onto the World Market in 1992
11.14c: New Chemical Entities and Biologicals First Launched Onto the World Market in 1993
11.14d: New Chemical Entities and Biologicals First Launched Onto the World Market in 1994
11.14e: New Chemical Entities and Biologicals First Launched Onto the World Market in 1995
11.14f: New Chemical Entities and Biologicals First Launched Onto the World Market in 1996
11.14g: New Chemical Entities and Biologicals First Launched Onto the World Market in 1997
11.14h: New Chemical Entities and Biologicals First Launched Onto the World Market in 1998

SECTION 12 - DEVELOPMENT TIMES
12.1: Introduction
12.2: Mean Development Times for NMEs First Marketed onto a Twenty-country Market by Leading Companies and Others (1984-1998)
12.3: Median Development Times for NMEs First Marketed onto a Twenty-country Market by Leading Companies and Others (1993-1997)
12.4: Profile of Development Times for NMEs First Marketed onto a Twenty-country Market by Leading Companies and Others (1984-1998)
12.5: Mean Development Times for Cardiovascular System, Nervous System, Anti-infective, Immune System and Anticancer NMEs First Marketed onto a Twenty-country Market (1983-1998)
12.6: Mean Development Times for Biotech Products and Other NMEs First Marketed onto a Twenty-country Market (1 January 1982-1998)
12.7: Analysis by Therapeutic Class of the 37 NMEs First Marketed (1984-1998) with Development Times of 6 Years or Less
12.8: Mean Development Times to Market in the USA, the UK and Japan (1984-1997)
12.9: Mean Time from First Synthesis to First Marketing Submission in the UK and USA (1984-1998)
12.10: Mean Time from NDA Submission to Approval, Time from IND Filing to NDA Submission and Time from IND Filing to NDA Approval for NCEs by Period of Approval (1963-1995)
12.11: Discovery Timelines by Process in 1996 and 2000

SECTION 13 - REVIEW TIMES
13.1: Introduction
13.2: Median NME Approval Times in Six Major Markets and the European Centralised Procedure (1995-1997)
13.3: Proportion of Compounds Approved Within Two Years in Six Major Markets (1996-1997)
13.4: Comparison of FDA and European Centralised Procedure Approval Times for NASs Submitted in 1996 and 1997
13.5: European Centralised Procedure Review Time Composites Based on Combination of Means Within Each Interval for NASs Approved in 1996, 1997 and 1998
13.6: Frequency of Selection of Reference Member State or Rapporteur/Co-rapporteur in the European Regulatory Procedures
13.7: Mean Total Review Time For National Authorisation of NASs in Reference Member States
13.8: Days During Clarification and Discussion Phase of Mutual Recognition at which Concerned Member States Raised Issues for Clarification
13.9: Mean Number of Questions by Concerned Member States During the Discussion Phase of Mutual Recognition
13.10: Mean Time to Concerned Member State National Authorisations Following the Start of Mutual Recognition
13.11: Strategies for the Generation of Clinical Data: Where are Clinical Trials Routinely Conducted?
13.12: Importance of Reasons for Choosing the Countries in which to Conduct Clinical Trials
13.13: Times During Development at which Companies Meet with Regulatory Authorities
13.14: The Use of FDA-Sponsor Conferences During NCE Development (1987-1995)
13.15: Percentage of the Total Data Package made up by Different Types of Trials
13.16: Number of Clinical Trials per US NDA (1994-1995)
13.17: Production of an International Dossier: One Company's Experience of Components Required by a Single Country/Region
13.18: Relative Importance of Factors that Contribute to the Increasing Size of the Clinical Dossier
13.19: US FDA Approval Times for Supplemental Indications for Recombinant Proteins

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