Analytical Excellence: A Roadmap to Quality by Design - Ahire, Harsharaj P.;Ghotkar, Ram S.
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This book, "Analytical Excellence: A Roadmap to Quality by Design," serves as a comprehensive guide to understanding and implementing the principles, strategies, and methodologies that underpin Analytical QbD in diverse fields, including pharmaceuticals, food safety, environmental monitoring, and more. The journey begins with an exploration of the fundamental concepts of Analytical QbD, shedding light on the importance of quality in analytical sciences, the need for a proactive approach, and the core principles that define QbD. Readers will gain a deep understanding of the Analytical Target…mehr

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Produktbeschreibung
This book, "Analytical Excellence: A Roadmap to Quality by Design," serves as a comprehensive guide to understanding and implementing the principles, strategies, and methodologies that underpin Analytical QbD in diverse fields, including pharmaceuticals, food safety, environmental monitoring, and more. The journey begins with an exploration of the fundamental concepts of Analytical QbD, shedding light on the importance of quality in analytical sciences, the need for a proactive approach, and the core principles that define QbD. Readers will gain a deep understanding of the Analytical Target Profile (ATP), its role in method development, and how it guides the creation of fit-for-purpose analytical methods. Delving further, the book navigates through the critical components of Analytical QbD, including risk assessment, method optimization, and robustness testing. Each component is dissected to reveal its underlying principles, methodologies, and practical applications, empowering analysts, scientists, and researchers to design, develop, and validate analytical methods that are reliable, precise, and aligned with quality objectives.
Autorenporträt
Harsharaj Ahire a obtenu son master en pharmacie en assurance qualité, avec plus de 3 ans d'expérience industrielle et 3 ans d'expérience académique. Il est président de l'Akhil Bhartiya Pharmacist Association (région de Mumbai) et a été reconnu comme le meilleur enseignant pour son travail exceptionnel. Il est professeur adjoint à l'Institut de pharmacie Shatabdi, à Nandurbar.