SKU/Artículo: AMZ-B0FH4TZ8DY
Analytical Quality By Design: A Complete Guide for the Implementation of the Latest Regulatory Requirements for Robust and Reliable Analytical Methods
Format:
Paperback
Detalles del producto
Disponibilidad:
En stock
En stock
Peso con empaque:
0.47 kg
0.47 kg
Devolución:
Sí
Sí
Condición
Nuevo
Nuevo
Producto de:
Amazon
Amazon
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USA
USA
Sobre este producto
- In a world where analytical results must be not just accurate, but also defensible and risk-based, AQbD is quickly becoming the global standard. This comprehensive guide empowers scientists, quality professionals, and regulatory teams with the tools and insights needed to design, validate, and maintain robust analytical methods under the latest international guidelines — including ICH Q14, ICH Q2(R2), and USP <1220>. What You’ll Learn - How to define Analytical Target Profiles (ATPs) and link them to Critical Method Parameters (CMPs) and Critical Analytical Attributes (CAAs) - How to apply Design of Experiments (DoE) to build and verify Method Operable Design Regions (MODRs) - How to integrate risk assessments (FMEA, Ishikawa) into method lifecycle management - How to calculate and report Measurement Uncertainty, Total Analytical Error, and method capability - How to design analytical control strategies aligned with Quality by Design principles - How to implement method validation and transfer in a modern regulatory environment Includes: - Case studies for HPLC, GC-MS, ICP-MS, ELISA, SDS-PAGE, and endotoxin testing - Ready-to-use templates for validation reports, uncertainty budgets, and risk tools - Graphical control strategy maps and MODR contour plots - Step-by-step walkthroughs of analytical method QbD implementation Whether you're modernizing legacy methods or developing new ones from scratch, this guide provides everything you need to build scientifically sound, regulator-ready analytical procedures from the ground up. Turn compliance into confidence. Transform data into decisions.
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AR$709.227
55% OFF
AR$322.376
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