Handbook Of Modern Pharmaceutical Analysis 3rd Edition PDF Free Download

September 24, 2022 by Writer

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.

Content Table

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.

Description:

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

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Key features

Topics of this Edition

Overview of Handbook Of Modern Pharmaceutical Analysis

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