商品簡介
The second edition of the best-selling practical guide to pharmaceutical analytics has been completely redesigned to take account of the Quality by Design (QbD) concept that has become the gold standard in pharmaceutical manufacturing. Two real-life case studies are included.
作者簡介
Joachim Ermer is Director of Analytical Processes and Technology in Quality Operations at Sanofi-Aventis in Frankfurt, Germany. He has a broad experience in analytical activities in pharmaceutical development and quality control, including method development, specification design, regulatory documentation, and validation.
Phil Nethercote is the analytical head for global manufacturing and supply at GlaxoSmithKline in Irvine, UK. He has over 20 years' experience in pharmaceutical analytical method development.
