Handbook of Analytical Quality by Design

Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis.

This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields.

Manualul calitatii analitice prin proiectare abordeaza pasii implicati in dezvoltarea si validarea metodelor analitice intr-un efort de a evita crizele de calitate in etapele ulterioare. Abordarea AQbD imbunatateste semnificativ performanta si robustetea metodei, care sunt cruciale in timpul studiilor interlaboratoare si care afecteaza, de asemenea, ciclul de viata analitic al metodei dezvoltate.