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Tables of Contents for Twenty-First Century Pharmaceutical Development
Chapter/Section Title
Page #
Page Count
Introduction
ix
Peter Blaisdell
About the Contributors
xv
Financing Strategies for Small Drug Developers
1
6
Matthew Frank
Fund-Raising
3
1
Public Financing
4
1
Early Funding Challenges
5
1
Conclusion
6
1
Managing Basic Research in the Twenty--First Century
7
56
Wolf-Dieter Busse
Business Challenges to Pharmaceutical Research Departments---A Summary
8
8
The Productivity Gap in Research and Development
The Financial Gap
The Innovation Gap
Premier Research Will Maintain its Importance
Portfolio Management Continues to Be the Key Driver
The Search for Successful Horizontal Integration Continues
Focusing on Highly Competitive Therapeutic Segments
Protein Therapeutics Provide Important Solutions for Many Very Sick Patients
From the Genomics Age to the Post-Genomics Era
A New Vision: Pharmacogenomics
Gene and Cell Therapies Will Come ... But to Which Level?
The New Biology in the Genomics Age
16
19
Gene Discovery and Validation Strategies in the Genomics Age
Polymorphisms and Disease-Specific Genotypes
Bioinformatics: Managing All the Data and Extracting Useful Information
Proteomics: Strategies for Protein Discovery
Functional Genomics
Molecular Pharmacology---a Bottleneck of Drug Discovery in the Genomics Age
Integration of High-Throughput Technology Platforms
29
6
High-Throughput Screening
Combinatorial Chemistry
Gene Chips
Moving Toward the Post-Genomics Era: The New Research Process and Solutions for the ``Longitude Problem''
35
7
The ``Longitude Problem'' of the Genomics Age
The New High-Throughput Research Process
Pharmacogenomics-Based Discovery
Optimization Strategies and Preclinical Chemistry in the Post-Genomics Era
Protein Therapeutics
42
9
The Rationale for Proteins as Drugs
The Disease Pyramid
Discovery of Novel Proteins and Peptides
Engineering of Proteins
Monoclonal Antibodies as Drugs
Low Attrition Rates and Short Development Times
The Impact of the Genomics Age
New Production Technologies
Gene Therapy
51
7
Medical Need
The Status of Drug Development
Vectors and Delivery Systems
Targeting and Genes
Pricing and Commercial Success
Acknowledgment
58
1
References
59
4
Protecting Intellectual Property in the New Millennium
63
16
Nadine Carol Chien
Methods of Securing Rights to Innovations
64
8
Trade Secrets
Patents Patent Infringement
Patent Term
Inventorship
Obtaining Rights to Innovations
72
3
Patent and License Strategies for the Twenty-First Century
75
4
The Marketing of Pharmaceutical Products
79
50
Dimitris Dogramatzis
The Pharmaceutical Industry
79
3
Ethical Considerations in Pharmaceutical Marketing
82
2
Money Waste
Intrusive
Manipulative
Lowers Healthcare Quality
Creates Social Inequality
Creates Unnecessary Demand
The Pharmaceutical Product Marketing Mix
84
22
Product Place
Price
Promotion
Marketing Strategy
106
8
From Worldwide Vision to Local Tactics
Strategic Planning
The Pharmaceutical Marketing Environment
112
2
The Pharmaceutical Industry and the Internet
114
5
Drug Dispensing over the Internet
Pharmaceutical Marketing Departments
119
3
Future Industry Trends
122
1
References
123
1
Further Reading
123
6
Regulatory Affairs in the Twenty-First Century
129
14
Meggi Raeder
From Discovery to First-in-Man Studies
130
4
The IND Process
Interactions with the FDA
The Clinical Development Phase
Preparation of a New Drug Application or Biologics Licensing Application
134
1
Electronic Submissions
Conducting Clinical Investigations Internationally
135
1
Clinical Investigations in Europe
Marketing Applications
Worldwide Harmonization
136
1
Regulatory Resources
137
2
The Role of Regulatory Affairs Personnel in Drug Development
Outsourcing
Regulatory Information---The Worldwide Web
Conclusions
139
2
References
141
2
Advances in Preclinical Toxicology Studies for Pharmaceutics
143
20
Larry E. Rodman
Regulatory Agencies and Guidelines for Toxicology Testing
144
1
Overview of Traditional Safety Studies for Pharmaceuticals
145
3
Toxicogenomics
148
2
Microarrays and Oligoarrays in Preclinical Toxicogenomics
Toxicoproteomics
150
1
Biomarkers
151
1
Biomarkers of Exposure
Biomarkers of Response or Effect
Biomarkers of Susceptibility
Alternative Animal Models in Preclinical Toxicology Studies
152
4
Traditional Animal Models
Genetically Altered Animals
Application of Transgenic and Knockout Models in Preclinical Toxicology Studies
Nontraditional Techniques and Assays in Animal Toxicology Studies
156
2
Alternatives to Using Animal Models in Preclinical Toxicology Testing
158
1
Conclusions
159
1
References
160
3
Drug Product Formulation Development
163
42
Terry Dahl
Preformulation Activities
164
2
Analytical Considerations
166
1
Experimental Design
167
1
Formulation Development
168
29
Parenteral Dosage Form Development
Liquid Oral Dosage Form Development
Solid Oral Dosage Form Development (Immediate-Release Tablets)
Solid Oral Dosage Form Development (Hard Gelatin Capsules)
Inhalation Dosage Form Development
Novel Drug Delivery Dosage Forms and Devices
Conclusion
197
1
References
198
7
Twenty--First Century Manufacturing
205
24
Mark Pemberton
The Development Process
206
6
Synthesis
Recovery and Purification
Formulation
Process Transfer
Manufacturing Operations
212
4
Process Consistency and Change Control
Manufacturing Facilities
216
5
GMP Compliance
Challenges in Biopharmaceutical Manufacturing
221
2
Fermentation
Purification
Aseptic Filling and Lyophilization
Phases of Manufacturing
223
2
Preclinical Development
Early Phase Clinical
Late Phase Clinical
Commercial
Outsourcing
Manufacturing in the Twenty-First Century
225
2
Conclusion
227
1
Acknowledgments
227
1
References
227
2
The Art (And Science) of Developing a Clinical Strategy
229
36
Patrick J. Scannon
The Product/Indication Profile
234
24
Label Information
Preclinical/Prior Clinical Status/Requirements
Clinical Proposal
Supporting Status/Requirements
Summary
The Global Strategic Plan
258
3
One Indication for One Route of Administration
Multiple Indications for One Route of Administration
Multiple Indications for Multiple Routes of Administration
The Clinical Strategy
Pointers on Implementation
261
2
Conclusions
263
1
Acknowledgments
263
2
The Role of Statistics in Drug Development
265
18
David R. Bristol
The Need for Statistical Input
265
1
Study Design
266
6
Parallel/Crossover
Patient Selection
Control
Multicenter Studies
Randomization
Blocked Randomization
Blinding (Masking)
Discontinuations
272
1
Specification of Efficacy Analyses
272
1
Estimation
273
1
Point Estimates
Confidence Intervals
Significance Testing (Hypothesis Testing)
274
4
General Principles of Significance Tests
p values
One-Sided/Two-Sided
Power/Sample Size
Multiplicity
278
1
Equivalence (Noninferiority) Studies
279
1
Summary
279
1
References
280
3
Project Management in Drug Development
283
12
Susan Burton
Key Project Initiation Steps
284
2
The Role of the Project Manager
286
1
Project Finance
287
3
Types of Contracts
Timelines, Budgets, and Resourcing
290
4
Conclusion
294
1
Outsourcing in Pharmaceutical Development
295
14
Peter Blaisdell
Characteristics of the Outsourcing Industry
296
3
When to Outsource
299
1
The Relationship Between the Sponsor and the CRO
300
2
Hypothetical Case Study: Outsourcing a Late Phase Clinical Trial
302
4
Conclusion
306
3
Diagnostics
309
22
Robert James
The Diagnostic Market
310
3
The Clinical Laboratory
Home Use Tests
Summary
Regulatory Needs for Diagnostic Development
313
7
Registration
Premarket Approval
Labeling
Good Manufacturing Practice
Manufacturing Diagnostics
320
5
Raw Materials
Production and Process Controls
Validation
Labeling and Packaging
Testing and Inspection
Product Release
International Diagnostic Product Activities
325
3
The Use of Standards in Diagnostic Development
328
1
Conclusion
329
2
Medical Devices
331
42
Charles Sidebottom
Requirements for a Quality Product Development Effort
332
9
Quality System Requirements
The Product Development Team
Product Planning
341
9
Identification of Needs
Preliminary Market Analysis
Feasibility Study
Advanced Product Planning
Regulatory Planning
Reimbursement Planning
Product Research
350
1
Product Design
351
5
Design and Development Planning
Design Inputs
Design Verification
Design Validation
Clinical Evaluation
356
4
Deciding When a Clinical Trial Is Required
Planning the Clinical Trial
Conducting the Study
Reporting Results
Good Manufacturing Practice
360
6
Purchasing Controls
Product Identification and Traceability
Acceptance Activities
Corrective and Preventive Action
Delivery to the Consumer (or User)
366
5
Installation
Servicing
Complaint Handling
Postmarket Surveillance and MDR
Phaseout and Disposition
References
371
2
Index
373