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Handbook Of Modern Pharmaceutical Analysis 3rd Edition PDF Free Download

The Book Handbook Of Modern Pharmaceutical Analysis is written by Satinder Ahuja and Stephen Scypinski. Today, modern pharmaceutical analysis involves much more than the analysis of active pharmaceutical ingredients or formulated products. There are many reasons for this change, one of which is our ability to better understand the physicochemical properties of pharmaceutical compounds through the use of advanced instrumental methods. In addition, there is a need to ensure the quality of pharmaceutical products throughout their shelf life. This requires us to study drug substance interactions with excipients in the presence of residual solvents, as well as other potential degradation reactions that may occur in the formulated product over a period of time under various stress conditions (these include conditions where may be subject during storage or shipment in the final configuration of the package).

Analytical chemistry has played an important role in the changes facing the pharmaceutical industry today. Traditionally seen as a service organization, the analytical department has become an important partner in the drug development process. In fact, the demand for analytical data has become a critical pathway activity for the selection of candidate molecules for full development.


Key features

This book describes what constitutes modern pharmaceutical analysis and the demands placed on pharmaceutical analysts, and shows how these demands are met effectively. It is well known in the pharmaceutical industry that pharmaceutical research and development (R&D) analysts play a full role in new drug development and follow-up activities to ensure that a new drug product meets established standards, is stable, and continues to meet the claimed quality throughout its useful life. Once the drug product is approved by regulatory authorities, ensuring that all batches of the drug product are manufactured to specified standards, the use of approved ingredients and production methods becomes the responsibility of pharmaceutical analysts in quality control (QC) or quality assurance (QA). Department.


Topics of this Edition

Chapter 1. Modern Pharmaceutical Analysis: An Overview
I. Identity and Purity Requirements
II. Bioavailability/Dissolution Requirements III. Regulatory Considerations
IV. Regulatory Compliance
V. International Conference on Harmonization VI. Global CMC NDA
VII. Highlights of Modern Pharmaceutical Analysis
Chapter 2. Combinatorial Chemistry and High-Throughput Screening in Drug Discovery and Development
I. Introduction
II. Combinatorial Methods
III. Methods for Structural Assignment
IV. Diversity V. Druglikeness VI. Designing Combinatorial Libraries with Optimal ADME Properties
VII. Existing Computational Methods for ADME Properties
VIII. Optimization Philosophy
IX. Applying Existing ADME Models to Combinatorial Library Design
X. The Future of ADME Modeling
XI. High-Throughput Screening and Combinatorial Chemistry
XII. Assay Plate Formats: Move to Miniaturization
XIII. Nonseparation or Homogeneous Assays
XIV. Identification of Receptor Antagonists for Chemokine Receptor and Bradykinin-1 by Screening a 150,000-Member Combinatorial Library
XV. Structure-based Design of Somatostatin Agonists
XVI. Conclusions
Chapter 3. Solid-State Analysis I. Introduction
II. Properties Associated with the Molecular Level
III. Properties Associated with the Particulate Level
IV. Properties Associated with the Bulk Level
V. Summary
Chapter 4. Degradation and Impurity Analysis for Pharmaceutical Drug Candidates
I. Residual Solvents and Water
II. Purposeful Degradation Studies
III. Isolation and Identification of Impurities/Degradants
IV. Mass Spectrometry in Identification of Impurities
V. Role of NMR
VI. Reference Standards
VII. Summary References
Chapter 5. Preformulation Studies I. Introduction
II. Preformulation Studies
III. Analytical Techniques and Instruments for Preformulation Studies
IV. Regulatory Requirements for Preformulation
V. Summary and Conclusions
Chapter 6. Solid Dosage-Form Analysis I. Introduction
II. Physicochemical Characterization Techniques
III. Near-Infrared Analysis
IV. Automation
V. Future Directions
VI. Summary VII. Acknowledgments References
Chapter 7. Parenteral Dosage Forms
I. Characteristics of Parenteral Dosage Forms
II. Pharmaceutical Analysis During Formulation and Process Development
III. Analytical Testing for Finished Parenteral Products
IV. Packaging Components Testing
V. Process Development Support
VI. In-Process Testing VII. Release Testing
VIII. Raw Material Testing
IX. Validation of Analytical Procedure
X. Stability-Indicating Methods XI. Method Transfer
XII. Cleaning Method Validation XIII. Admixture Studies
XIV. Microbiological Testing of Parenteral Formulations
XV. Sterility Testing
XVI. Bacterial Endotoxin Testing
XVII. Particulate Matter Testing
XVIII. Bioburden Testing of Parenteral Product Solution
XIX. Introduction to Cleaning Validation XX. Swab Selection (Recovery and Compatability Studies) XXI. Technician Qualification
XXII. Sampling
XXIII. Acceptance Criteria
XXIV. Methods of Analysis XXV. Grouping/Matrix Approach
XXVI. Validation Protocol XXVII. Validation Report XXVIII. Summary
Chapter 8. New Drug Delivery Systems I. Introduction
II. Oral Drug Delivery
III. Direct Drug Delivery
IV. Dermatological Delivery System V. Tumor-Targeted Drug Delivery Systems
VI. Biodegradable Drug Delivery System
VII. Protein Drug Delivery System
VIII. Devices
Chapter 9. Compendial Testing I. Introduction
II. A Brief History of the United States Pharmacopeia
III. Compendial Testing for Formulated Products and Active Ingredients
IV. Which Compendium to Use and When to Use It V. Validation
VI. Harmonization of Testing Methods for Multicountry Submission
VII. Conclusions
VIII. Acknowledgments References
Chapter 10. Method Development I. Introduction
II. Overview of Separation Methods
III. High-Performance Liquid Chromatography
IV. Thin-Layer Chromatography
V. Gas Chromatograph
VI. Supercritical-Fluid Chromatography
VII. Capillary Electrophoresis
VIII. Conclusions IX. Summary
Chapter 11. Setting Up Specifications I. Introduction
II. Setting Specifications at Different Stages of Drug Development
III. International Conference on Harmonization Guidelines
IV. Pharmacopeias and Specifications
V. Statistical Considerations in Setting Specifications
Chapter 12. Validation of Pharmaceutical Test Methods I. Background and Chapter Overview
II. Validation Terminology and Definitions
III. Method Development and Its Influence on Method Validation
IV. Validation Requirements of The Method V. Validation Documentation
VI. Validation Experimentation
VII. Method Transfer
VIII. Revalidation IX. Reference Standards
Chapter 13. Stability Studies I. Introduction
II. Operational Issues
III. Excipients
IV. Drug Substance
V. Drug Product
VI. Summary Glossary
Chapter 14. Analytical Methodology Transfer I. Introduction
II. The Drug Development Process
III. Types of Method Transfer
IV. Requirements and Elements of Analytical Technology Transfer
V. Technical Transfer Time Line/Project Plan
VI. Analysis of Results/Statistical Packages
VII. Analyst Certification and Training VIII. Transfer of Technical Ownership
IX. Chapter Summary References
Chapter 15. Pharmaceutical Analysis Documentation I. Scope
II. Introduction III. Pharmaceutical Analysis During Product Life Cycle
IV. Regulatory Documents
V. Compliance Documents
VI. Research Documents
VII. Summary
VIII. Conclusions Appendix I: References for CMC Guidances
Chapter 16. An Innovative Separation Platform: Electrophoretic Microchip Technology I. Introduction
II. Microchip Fabrication
III. Detection Techniques
IV. Pharmaceutical Potential
V. Concluding Remarks VI. Summary References

Overview of Handbook Of Modern Pharmaceutical Analysis

This book describes the role that modern pharmaceutical analysis plays in the development of new drugs. Detailed information is provided on how the quality of pharmaceutical products is assured from the point of discovery until the patient uses the medicine. Coverage includes cutting-edge topics such as high-throughput screening and combinatorial chemistry assays, formulation development, stability studies, international documentation and regulatory issues, and future technologies likely to impact the field. Emphasis is placed on current, easy-to-follow methods that readers can apply in their laboratories.



Book Name Handbook Of Modern Pharmaceutical Analysis
Author of Book Satinder Ahuja, Stephen Scypinski
Edition 3rd
Language English
Format PDF
Category Pharma Books



Handbook Of Modern Pharmaceutical Analysis



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