Essential Statistics for the Pharmaceutical Sciences by Philip Rowe Hardcover - 308 pages Shipped in CLICK HERE Cat.# JW-PHM1 $162.70 BUY Published:  2007   ISBN:  9780470034705

Essential Statistics for the Pharmaceutical Sciences is a clear, accessible introduction to the key statistical techniques employed for the analysis of data within these subject areas. It explains why statistics are necessary and discusses the issues that experimentalists need to consider. It covers the whole process from planning an experiment to interpreting the results and avoids unnecessary calculation methodology. This unique textbook:

• Explains how data is described and how it is tested for changes or relationships
• Takes examples from a biomedical/pharmaceutical context to enhance student understanding
• Is aimed at statistics users rather than statisticians - no prior knowledge of statistics is assumed
• Describes the most commonly used statistical methods in terms of their purpose, when they should be used and what they mean once they have been performed
• Features a supplementary website which includes additional methods, instructions for performing tests and specific information for carrying out each text in packages such as SPSS and Minitab. Also included are example data sets as Excel files to enable readers to try the analyses without re-entering the data
• Provides brief generalized instructions for performing the tests using any stats package

Essential Statistics for the Pharmaceutical Sciences takes a new and innovative approach to statistics with an informal style that appeals to all science students looking for an introduction to statistics. It is especially helpful for students taking Biomedical or Pharmaceutical-based science degrees, and is also a useful guide for researchers.

Table of Contents:

Preface
Statistical packages

PART 1. DATA TYPES

1. Data types
1.1 Does it really matter?
1.2 Interval scale data
1.3 Ordinal scale data
1.4 Nominal scale data
1.5 Structure of this book
1.6 Chapter summary

PART 2. INTERVAL-SCALE DATA

2. Descriptive statistics
2.1 Summarizing data sets
2.2 Indicators of central tendency. mean, median and mode
2.3 Describing variability. standard deviation and coefficient of variation
2.4 Quartiles. another way to describe data
2.5 Using computer packages to generate descriptive statistics
2.6 Chapter summary

3. The normal distribution
3.1 What is a normal distribution?
3.2 Identifying data that are not normally distributed
3.3 Proportions of individuals within one or two standard deviations of the mean
3.4 Chapter summary

4. Sampling from populations. the SEM
4.1 Samples and populations
4.2 From sample to population
4.3 Types of sampling error
4.4 What factors control the extent of random sampling error?
4.5 Estimating likely sampling error. The SEM
4.6 Offsetting sample size against standard deviation
4.7 Chapter summary

5. Ninety-five per cent confidence interval for the mean
5.1 What is a confidence interval?
5.2 How wide should the interval be?
5.3 What do we mean by ‘95 per cent’ confidence?
5.4 Calculating the interval width
5.5 A long series of samples and 95 per cent confidence intervals
5.6 How sensitive is the width of the confidence interval to changes in the SD, the sample size or the required level of confidence?
5.7 Two statements
5.8 One-sided 95 per cent confidence intervals
5.9 The 95 per cent confidence interval for the difference between two treatments
5.10 The need for data to follow a normal distribution and data transformation
5.11 Chapter summary

6. The two-sample t-test(1). Introducing hypothesis tests
6.1 The two-sample t-test. an example of a hypothesis test
6.2 ‘Significance’
6.3 The risk of a false positive finding
6.4 What factors will influence whether or not we obtain a significant outcome?
6.5 Requirements for applying a two-sample t-test
6.6 Chapter summary

7. The two-sample t-test (2).The dreaded P value
7.1 Measuring how significant a result is
7.2 P values
7.3 Two ways to define significance?
7.4 Obtaining the P value
7.5 P values or 95 per cent confidence intervals?
7.6 Chapter summary

8. The two-sample t-test (3). False negatives, power and necessary sample sizes
8.1 What else could possibly go wrong?
8.2 Power
8.3 Calculating necessary sample size
8.4 Chapter summary

9. The two-sample t-test(4).Statistical significance, practical significance and equivalence
9.1 Practical significance. is the difference big enough to matter?
9.2 Equivalence testing
9.3 Non-inferiority testing
9.4 P values are less informative and can be positively misleading
9.5 Setting equivalence limits prior to experimentation
9.6 Chapter summary

10. The two-sample t-test(5). One-sided testing
10.1 Looking for a change in a specified direction
10.2 Protection against false positives
10.3 Temptation!
10.4 Using a computer package to carry out a one-sided test
10.5 Should one-sided tests be used more commonly?
10.5 Chapter summary

11. What does a statistically significant result really tell us?
11.1 Interpreting statistical significance
11.2 Starting from extreme scepticism
11.3 Chapter summary

12. The paired t-test. comparing two related sets of measurements
12.1 Paired data
12.2 We could analyse the data using a two-sample t-test
12.3 Using a paired t-test instead
12.4 Performing a paired t-test
12.5 What determines whether a paired t-test will be significant?
12.6 Greater power of a paired t-test
12.7 The paired t-test is only applicable to naturally paired data
12.8 Choice of experimental design
12.9 Requirements for applying a paired t-test
12.10 Sample sizes, practical significance and one-sided tests
12.11 Summarizing the differences between the paired and two-sample t-tests
12.12 Chapter summary

13. Analyses of variance. going beyond t-tests
13.1 Extending the complexity of experimental designs
13.2 One-way analysis of variance
13.3 Two-way analysis of variance
13.4 Multi-factorial experiments
13.5 Keep it simple. Keep it powerful
13.6 Chapter summary

14. Correlation and regression. relationships between measured values
14.1 Correlation analysis
14.2 Regression analysis
14.3 Multiple regression
14.4 Chapter summary

PART 3. NOMINAL-SCALE DATA

15. Describing categorized data
15.1 Descriptive statistics
15.2 Testing whether the population proportion might credibly be some pre-determined figure
15.3 Chapter summary

16. Comparing observed proportions. the contingency chi-square test
16.1 Using the contingency chi-square test to compare observed proportions
16.2 Obtaining a 95 per cent CI for the change in the proportion of expulsions. is the difference large enough to be of practical significance?
16.3 Larger tables. attendance at diabetic clinics
16.4 Planning experimental size
16.5 Chapter summary

PART 4. ORDINAL-SCALE DATA

17. Ordinal and non-normally distributed data.Transformations and non-parametric tests
17.1 Transforming data to a normal distribution
17.2 The Mann-Whitney test. a non-parametric method
17.3 Dealing with ordinal data
17.4 Other non-parametric methods
17.5 Chapter summary
Appendix to Chapter 17

PART 5. SOME CHALLENGES FROM THE REAL WORLD

18. Multiple testing
18.1 What is it and why is it a problem?
18.2 Where does multiple testing arise?
18.3 Methods to avoid false positives
18.4 The role of scientific journals
18.5 Chapter summary

19. Questionnaires
19.1 Is there anything special about questionnaires?
19.2 Types of questions
19.3 Designing a questionnaire
19.4 Sample sizes and return rates
19.5 Analysing the results
19.6 Confounded epidemiological data
19.7 Multiple testing with questionnaire data
19.8 Chapter summary

PART 6. CONCLUSIONS

20. Conclusions
20.1 Be clear about the purpose of the experiment
20.2 Keep the experimental design simple and therefore clear and powerful
20.3 Draw up a statistical analysis plan as part of the experimental design. it is not a last minute add-on
20.4 Explore your data visually before launching into statistical testing
20.5 Beware of multiple analyses
20.6 Interpret both significance and non-significance with care

Index

Pharmacovigilance (Ed.2) by Ronald D. Mann, and Elizabeth B. Andrews Hardcover - 702 pages Shipped in CLICK HERE Cat.# JW-PHM2 $397.25 BUY Published:  2007   ISBN:  9780470018033

Written by an international team of outstanding editors and contributors, Pharmacovigilance, 2nd Edition is the definitive text on this important subject. The new edition has been completely revised and updated to include the latest theoretical and practical aspects of pharmacovigilance including legal issues, drug regulatory requirements, methods of signal generation, reporting schemes and pharmacovigilance in selected system-organ classes. .

• The editors and contributors are of excellent standing within the pharmacovigilance community
• The text provides exemplary coverage of all the relevant issues
• The definitive book on the subject

Table of Contents:

Contributors
Preface
Foreword

PART I. THE BASIS OF PHARMACOVIGILANCE.

1. Introduction
2. Legal Basis – EU
3. Legal Basis – United States
4. Ethical Oversight, Consent and Confidentiality
5. Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation
6. Periodic Safety Update Reports
7. Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials
8. Mechanisms of Adverse Drug Reactions
9. Micturin and Torsades de Pointes
10. Withdrawal of Terodiline: A Tale of Two Toxicities
11. Nomifensine and Haemolytic Anaemia

PART II. SIGNAL GENERATION.

12. WHO Programme – Global Monitoring
13. Medical Dictionary for Regulatory Activities (MedDRAŽ)
14. Regulatory Pharmacovigilance in the EU
15. Spontaneous Reporting – UK
16. Spontaneous Reporting – France
17. Spontaneous Reporting in Germany
18. Spontaneous Reporting – United States
19. Statistical Methods of Signal Detection
20. Statistical Methods of Evaluating Pharmacovigilance Data
21. Data Mining in Pharmacovigilance: A View from the Uppsala Monitoring Centre
22. Pharmacovigilance in the Netherlands
23. CIOMS Working Groups and their Contribution to Pharmacovigilance
24. PEM in the UK
25. PEM in New Zealand
26. MEMO in the United Kingdom
27. The General Practice Research Database: Now and the Future
28. Overview of North American Databases
29. Other Databases in Europe for the Analytic Evaluation of Drug Effects
30. Surveillance for Medical Devices – USA
31. Pharmacovigilance and Risk Management in Japan

PART III. PHARMACOVIGILANCE AND SELECTED SYSTEM ORGAN CLASSES

32. Dermatological ADRs
33. Gastrointestinal ADRs
34. Haematological ADRs
35. Hepatic ADRs
36. Ocular Side Effects of Prescription Medications
37. Drug Safety in Pregnancy
38. Renal Adverse Drug Reactions
39. Anaesthetic Adverse Drug Reactions
40. Pharmacovigilance in Pediatrics
41. The Cardiovascular Spectrum of Adverse Drug  Reactions
42. Drugs and the Elderly

PART IV. KEY CURRENT TOPICS

43. US Activities in Risk Management of Pharmaceutical Products
44. Risk Management – a European Regulatory View
45. The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents
46. Pharmacoepidemiology of Hormone Therapy: An Evolving Picture
47. NSAIDs – COX-2 Inhibitors – Risks and Benefits
48. Introduction to Pharmionics: The Vagaries in Ambulatory Patients’ Adherence to Prescribed Drug Dosing Regimens, and Some of Their Clinical and Economic Consequences

PART V. LESSONS AND DIRECTIONS.

49. Teaching and Learning Pharmacovigilance
49b. Practical Experience in Teaching Pharmacovigilance
50. Fatal Medication Errors and Adverse Drug Reactions – Coroners’ Inquests and Other Sources
51. Pharmacogenetics and the Genetic Basis of ADRs
52. Keynote Clinical Lessons from Pharmacovigilance

Index

Principles and Practice of Pharmaceutical Medicine by Lionel D. Edwards, Anthony W. Fox, Peter D. Stonier, and Andrew J. Fletcher Hardcover - 792 pages Shipped in CLICK HERE Cat.# JW-PHM3 $288.15 BUY Published:  2007   ISBN:  9780470093139

The long awaited second edition of Principles and Practice of Pharmaceutical Medicine provides an invaluable guide to all areas of drug development and medical aspects of marketing. The title has been extensively revised and expanded to include the latest regulatory and scientific developments. New chapters include:

• European Regulations
• Ethics of Pharmaceutical Medicine
• Licensing and Due Diligence
• Pharmacogenomics

Encompassing the entire spectrum of pharmaceutical medicine, it is the most up-to-date international guide currently available.

Review of the first edition:

“This book was a joy to read and a joy to review. All pharmaceutical physicians should have a copy on their bookshelves, all pharmaceutical companies should have copies in their libraries.”
—BRITISH ASSOCIATION OF PHARMACEUTICAL PHYSICIANS

Table of Contents:

Preface to the First Edition
Preface to the Second Edition
About the Editors
Contributors

SECTION I: OVERVIEW OF PHARMACEUTICAL MEDICINE

1. The Practice and Practitioners of Pharmaceutical Medicine
2. Pharmaceutical Medicine as a Medical Specialty
3. Clinical Research Education and Training for Biopharmaceutical Staff

SECTION II: DRUG DISCOVERY AND DEVELOPMENT

Introduction

4. Drug Discovery: Design and Serendipity
5. Pharmaceutics
6. Non-clinical Toxicology
7. Informed Consent
8. Phase I: The First Opportunity for Extrapolation from Animal Data to Human Exposure
9. Phase II and Phase III Clinical Studies
10. Phase IV Drug Development: Post-Marketing Studies
11. Site Management
12. Good Clinical Practices
13. Quality Assurance, Quality Control, and Audit
14. The Unique Role of Over-the-counter Medicine

SECTION III: SPECIAL POPULATIONS AND REQUIRED SPECIAL STUDIES.

Introduction

15. Drug Research in Older Patients
16. Drug Development Research in Women
17. Clinical Research in Children
18. Racial and Ethnic Issues in Drug Registration
19. Hepatic and Renal Failure
20. Drug Interactions
21. Orphan Drugs

SECTION IV: APPLIED ASPECTS OF DRUG DEVELOPMENT

Introduction

22. Biotechnology Products and Development
23. Pharmacoeconomics: Economic and Humanistic Outcomes
24. Pharmacoepidemiology and the Pharmaceutical Physician
25. Statistical Principles and Application in Biopharmaceutical Research
26. Data Management
27. Patient Compliance: Pharmionics, A New Discipline
28. Monitoring Drug Concentrations in Clinical Practice
29. Generics
30. Complementary Medicines

SECTION V: DRUG REGULATION

Introduction

31. United States Regulations
32. Special US Regulatory Procedures: Emergency and Compassionate INDs and Accelerated Product Approvals
33. The Development of Human Medicines Control in Europe From Classical Times to the Year 2000
34. Medicines Regulation in the European Union
35. Japanese Regulations
36. Drug Registration and Pricing in the Middle East

SECTION: VI: MEDICAL SERVICES

Introduction

37. Medical Affairs
38. Drug Labeling
39. Drug Surveillance
40. Data Mining
41. Risk Management in Product Approval and Marketing
42. Publishing Clinical Studies
43. Organizing and Planning Local, Regional, National, and International Meetings and Conferences
44. Drug Withdrawals from the Market - Causes and Consequences

SECTION VII: LEGAL AND ETHICAL ASPECTS OF PHARMACEUTICAL MEDICINE

Introduction

45. Introduction to Bioethics for Pharmaceutical Professionals
46. Pharmaceutical Medicine and the Law
47. Pharmaceutical Product Liability
48. Patents
49. Fraud and Misconduct in Clinical Research

SECTION VIII: BUSINESS ASPECTS

Introduction

50. The Multinational Corporations: Cultural Challenges, the Legal/Regulatory Framework and the Medico-commercial Environment
51. Advertising and Marketing
52. Pharmaceutical Medicine in the East
53. Financial Aspects of Clinical Trials
54. Outsourcing Clinical Drug Development Activities to Contract Research. Organizations (CROs): Critical Success Factors
55. The Impact of Managed Care on the Pharmaceutical Industry

Appendix - Useful Internet Links
Index

Short Protocols in Pharmacology and Drug Discovery by S. J. Enna Softcover - 916 pages Shipped in CLICK HERE Cat.# JW-PHM4 $149.05 BUY Published:  2007   ISBN:  9780470095263

Short Protocols in Pharmacology and Drug Discovery provides condensed descriptions of more than 350 methods compiled from the successful title Current Protocols in Pharmacology. The book is specifically designed to provide quick access to step-by-step instructions for the essential methods used in every major area of pharmaceutical research, and especially stresses drug discovery techniques.

This volume is an authoritative and indispensable guide for all life scientists, researchers, and students at the graduate and advanced undergraduate level, doing research in academic, government, and pharma/biotech laboratories.

HPLC for Pharmaceutical Scientists by Yuri V. Kazakevich, and Rosario LoBrutto Hardcover - 1,104 pages Shipped in CLICK HERE Cat.# JW-PHM5 $201.75 BUY Published:  2007   ISBN:  9780471681625

HPLC for Pharmaceutical Scientists is an excellent book for both novice and experienced pharmaceutical chemists who regularly use HPLC as an analytical tool to solve challenging problems in the pharmaceutical industry. It provides a unified approach to HPLC with an equal and balanced treatment of the theory and practice of HPLC in the pharmaceutical industry.

In-depth discussion of retention processes, modern HPLC separation theory, properties of stationary phases and columns are well blended with the practical aspects of fast and effective method development and method validation. Practical and pragmatic approaches and actual examples of effective development of selective and rugged HPLC methods from a physico-chemical point of view are provided.

This book elucidates the role of HPLC throughout the entire drug development process from drug candidate inception to marketed drug product and gives detailed specifics of HPLC application in each stage of drug development.

The latest advancements and trends in hyphenated and specialized HPLC techniques (LC-MS, LC-NMR, Preparative HPLC, High temperature HPLC, high pressure liquid chromatography) are also discussed.

Table of Contents:

PREFACE
CONTRIBUTORS
PART I HPLC THEORY AND PRACTICE

1. Introduction

1.1 Chromatography in the Pharmaceutical World
1.2 Chromatographic Process
1.3 Classification
1.4 History of Discovery and Early Development (1903–1933)
1.5 General Separation Process
1.6 Types of HPLC
1.7 HPLC Descriptors (Vr, k, N, etc.)

2. HPLC

2.1 Introduction
2.2 Basic Chromatographic Descriptors
2.3 Efficiency
2.4 Resolution
2.5 HPLC Retention
2.6 Retention Mechanism
2.7 General Column Mass Balance
2.8 Partitioning Model
2.9 Adsorption Model
2.10 Total and Excess Adsorption
2.11 Mass Balance in Adsorption Model
2.12 Adsorption of the Eluent Components
2.13 Void Volume Considerations
2.14 Thermodynamic Relationships
2.15 Adsorption-Partitioning Retention Mechanism
2.16 Secondary Equilibria
2.17 Gradient Elution Principles
2.18 Types of Analyte Interactions with the Stationary Phase
2.19 Conclusion

3. Stationary Phases

3.1 Introduction
3.2 Type of Packing Material (Porous, Nonporous, Monolithic)
3.3 Base Material (Silica, Zirconia, Alumina, Polymers)
3.4 Geometry
3.5 Adsorbent Surface Chemistry
3.6 Surface of Chemically Modified Material
3.7 Polymer-Based Adsorbents
3.8 Stationary Phases for Chiral Separations
3.9 Columns

4. Reversed-Phase HPLC

4.1 Introduction
4.2 Retention in Reversed-Phase HPLC
4.3 Stationary Phases for RPLC
4.4 Mobile Phases for RPLC
4.5 pH Effect on HPLC Separations
4.6 Effect of Organic Eluent Composition on Analyte Ionization
4.7 Synergistic Effect of pH, Organic Eluent, and Temperature on Ionizable Analyte Retention and Selectivity
4.8 Examples of Applying pH Shift and Analyte pKa Shift Rules
4.9 Effect of Temperature on Analyte Ionization
4.10 Ion-Interaction Chromatography
4.11 Concluding Remarks

5. Normal-Phase HPLC

5.1 Introduction
5.2 Theory of Retention in Normal-Phase Chromatography
5.3 Effect of Mobile Phase on Retention
5.4 Selectivity
5.5 Applications
5.6 Conclusions

6. Size-Exclusion Chromatography

6.1 Separation of the Analyte Molecules by Their Size
6.2 Molecular Size and Molecular Weight
6.3 Separation Mechanism
6.4 Calibration
6.5 Columns
6.6 Molecular Weight Distribution
6.7 Effect of Eluent
6.8 Effect of Temperature
6.9 Detectors
6.10 Solving Mass Balance Issues
6.11 Aqueous SEC Applications

7. LC/MS: Theory, Instrumentation, and Applications to Small Molecules

7.1 Introduction
7.2 Ionization Methods and LC/MS Interfaces
7.3 Mass Analyzers
7.4 Role of Instrumental Parameters on Ionization Efficiency in LC/MS
7.5 Effect of Mobile-Phase Composition on Ionization Efficiency in LC/MS
7.6 MS Interpretation
7.7 Practical Applications
7.8 Conclusions

8. Method Development

8.1 Introduction
8.2 Types of Methods
8.3 Defining the Method
8.4 Method Development Considerations
8.5 Method Development Approaches
8.6 Effect of pH on UV Absorbance
8.7 Analyte pKa—From an Analytical Chemist’s Perspective
8.8 Reversed-Phase Versus Normal-Phase Separations
8.9 Instrument/System Considerations
8.10 Column Testing (Stability and Selectivity)
8.11 Concluding Remarks

9. Method Validation

9.1 Introduction
9.2 Validation Report
9.3 Revalidation
9.4 Assignment of Validation Parameters
9.5 Distinguishing Drug-Related and Non-Drug-Related Degradation Products
9.6 Concluding Remarks

10. Computer-Assisted HPLC and Knowledge Management

10.1 Introduction
10.2 Prediction of Retention and Simulation of Profiles
10.3 Optimization of HPLC Methods
10.4 Structure-Based Tools
10.5 Conclusion

PART II HPLC IN THE PHARMACEUTICAL INDUSTRY

11. The Expanding Role of HPLC in Drug Discovery

11.1 Introduction
11.2 Applications of HPLC/MS for Protein Identification and Characterization
11.3 Applications of HPLC/MS/MS in Support of Protein Chemistry
11.4 Applications of HPLC/MS/MS in Support of Assay Development and Screening
11.5 Sources of Compounds for Biological Screening
11.6 HPLC/MS Analysis to Support Compound Characterization
11.8 Higher-Throughput Purification Strategies
11.9 ADME Applications
11.10 Fast Serial ADME Analyses Incorporating LC-MS and LC-MS/MS
11.11 Parallel Approaches to Speeding ADME Analyses
11.12 Automated “Intelligent” Metabolic Stability and Metabolite ID
11.13 Conclusions

12. Role of HPLC in Preformulation

12.1 Introduction
12.2 Initial Physicochemical Characterization (Discovery Support)
12.3 Chemical Stability
12.4 Salt Selection
12.5 Polymorphism
12.6 Preformulation Late Stage (Development Support)
12.7 Conclusions

13. The Role of Liquid Chromatography–Mass Spectrometry in Pharmacokinetics and Drug Metabolism

13.1 Introduction
13.3 Tandem-Mass Spectrometry (MS/MS)
13.4 Sample Preparation Using an Off-Line Approach
13.5 Automated Sample Transfer
13.6 Sample Processing Using an On-Line Approach
13.7 Matrix Effect and Ion Suppression
13.8 Regulatory Requirements for LC/MS Method Validation
13.9 RitalinŽ: An Application of Enantioselective LC-MS/MS
13.10 GleevecTM (STI571)
13.11 Biomarkers
13.12 Conclusions

14. Role of HPLC in Process Development

14.1 Responsibilities of the Analytical Chemist During Process Development
14.2 HPLC Separation Modes
14.3 Sample Preparation.
14.4 HPLC Detectors
14.5 Method Development
14.6 In-Process Monitoring
14.7 Impurity Identification
14.8 Establishment of HPLC Selectivity by Stress Studies
14.9 HPLC Method Validation
14.10 Technology Transfer
14.11 Concluding Remarks

15. Role of HPLC During Formulation Development

15.1 Introduction
15.2 Prerequisite for Analytical Chemists During Formulation Development
15.3 Properties of Drug Substance
15.4 Properties of Excipients
15.5 Impact of Excipients on Degradation of API(s)
15.6 Test Methods for Most Common Dosage Forms in which HPLC Is the Primary Technique
15.7 Forced Decomposition
15.8 Compatibility of Excipients with API(s) (Type and Ratio)
15.9 Mass Balance
15.10 Summary of Assay and Related Substances
15.11 Uniformity of Dosage Units
15.12 Blend Uniformity (BU)
15.13 Cleaning Verification
15.14 Extractables/Leachables
15.15 Dissolution
15.16 Method Development
15.17 Method Validation
15.18 Testing of Samples
15.19 Automation Opportunities
15.20 Implementation of Alternative Technologies
15.21 Challenges and Future Trends
A15.1 Addendum (Common Functional Groups)
A15.1.1 Carbonyls
A15.1.2 Nitrogen Functional Groups
A15.1.3 Ethers, Thioethers
A15.1.4 Alkyl/Aryl Halides
A15.1.5 Hydroxyls
A15.1.6 Thiols
A15.1.7 Phenols
A15.1.8 Olefins
A15.1.9 Dimerization
A15.1.10 Ring Transformations

16. The Role of HPLC in Technical Transfer and Manufacturing

16.1 Introduction
16.2 Prerequisites for Transfer of HPLC Methods
16.3 Types of Technical Transfer
16.4 Different Approaches for Technical Transfer and Manufacturing
16.5 Potential Pitfalls During Technical Transfer and Manufacturing
16.6 Conclusion

PART III HYPHENATED TECHNIQUES AND SPECIALIZED HPLC SEPARATIONS

17. Development of Fast HPLC Methods

17.1 Introduction
17.2 Basic Theory
17.3 Monolithic Columns
17.4 Ultra-High-Pressure Liquid Chromatography
17.5 Separations on Chips
17.6 Optimizing Gradient Separations for Speed
17.7 Instrumental Requirements for Operating High-Efficiency Columns
17.8 Conclusions

18. Temperature as a Variable in Pharmaceutical Applications

18.1 The Influence of Temperature on Chromatography
18.2 Effects on Method Transferability and Reproducibility
18.3 Elevated Temperature and Pharmaceutical Separations
18.4 Superheated Water Chromatography
18.6 Subambient Separations
18.7 Conclusion

19. LC/MS Analysis of Proteins and Peptides in Drug Discovery

19.1 Introduction
19.2 General Strategies for Analysis of Proteins/Peptides
19.3 Applications for Biotechnology Products and Drug Targets
19.4 Conclusions

20. LC-NMR Overview and Pharmaceutical Applications

20.1 Introduction
20.2 Historical Background of NMR
20.3 LC-NMR
20.4 LC-MS-NMR (or LC-NMR-MS or LC-NMR/MS)
20.5 Conclusions

21. Trends in Preparative HPLC

21.1 Introduction
21.2 Method Development in Preparative HPLC
21.3 Columns and Stationary Phases
21.4 Choice of Preparative LC Technology
21.5 Detection Tools
21.6 Conclusion

22. Chiral Separations

22.1 Introduction
22.2 Separation of Enantiomers Through the Formation of Diastereomers
22.3 Molecular Interactions
22.3.5 Charge Transfer
22.4 Mixed Types of Interaction
22.5 Ligand Exchange
22.6 Chiral Mobile Phases
22.7 Method Development for Chiral Separation
22.8 Concluding Remarks

CHEMICAL AND DRUG COMPOUND INDEX
SUBJECT INDEX

Medicines from Animal Cell Culture by Glyn Stacey, and John Davis Hardcover - 696 pages Shipped in CLICK HERE Cat.# JW-PHM6 $340.85 BUY Published:  2007   ISBN:  9780470850947

Medicines from Animal Cell Culture focuses on the use of animal cell culture, which has been used to produce human and veterinary vaccines, interferon, monoclonal antibodies and genetically engineered products such as tPA and erythropoietin. It also addresses the recent dramatic expansion in cell-based therapies, including the use of live cells for tissue regeneration and the culture of stem cells.

Medicines from Animal Cell Culture:

• Provides comprehensive descriptions of methods for cell culture and nutrition as well as the technologies for the preservation and characterisation of both the cells and the derived products
• Describes the preparation of stem cells and others for use in cell-based therapies – an area of burgeoning research
• Includes experimental examples to indicate expected results
• Covers regulatory issues from the UK, the EU and the USA and reviews how these are developing around the world
• Addresses the key issues of standardisation and validation with chapters on GLP and GMP for cell culture processes

Delivering insight into the exciting world of biological medicines and directions for further investigation into specific topics, Medicines from Animal Cell Culture is an essential resource for researchers and technicians at all levels using cell culture within the pharmaceutical, biotechnology and biomedical industries. It is of value to laboratory managers in these industries and to all those interested in this topic alike.

Table of Contents:

Preface
Foreword

History and Overview

1. The Development of Animal Cell Products

Fundamental Elements of Cell Growth Media

2. Water Quality
3. Basal Media and Serum-free Culture
4. Serum

Cell Engineering for Recombinant Products

5. Recombinant Products from Mammalian Cells
6. Recombinant Viral Vaccines
7. Baculovirus expression systems
8. Cell Cloning and Stability
9. Gene Therapy Products

Technology and Facilities for Cell Culture Scale-up

10. Culture Vessels and Matrices for Scale-up
11. Process Design and Development
12. Facilities
13. Strategies for Process Control
14. Service and equipment for upstream processing
15. Validation of Facilities & Equipment

Processing and Preservation of Cells and Products

16. Cell Harvesting and Clarification of Culture Supernatants
17. Protein Concentration
18. Chromatographic purification
19. Virus clearance/inactivation
20. Formulation and freeze-drying
21. Preservation of Cells and Tissue

Properties of Cell Products

22. From Gene To Product: An Overview
23. Protein analysis
24. Glycosylation of Medicinal Products
25. Immunogenicity of Cell Derived Vaccines
26. Potency testing
27. Stability of Product on Storage

Cells as Products

28. Tissue Engineering
29. Stem Cell Therapy
30. Cells as Vaccines

Risk Assessment and Regulatory Aspects

31. Risk Assessment of Cells and Processes
32. Standardisation of Cell Cultures
33. GLP for Cell Culture Processes
34. GMP for Cell Culture Processes
35. International Regulatory Framework
36. Legal and Ethical Issues for Cell Therapy