Analysis and critical review of ICH Q8, Q9 and Q10 from a generic pharmaceutical industry view point

• Váldodahkkit: Ljuba Karanakov (Dahkki), Jasmina Tonic-Ribarska (Dahkki), Marija Glavas-Dodov (Dahkki), Suzana Trajkovic-Jolevska (Dahkki)
• Materiálatiipa: Girji
• Almmustuhtton: University Ss Cyril and Methodius in Skopje, Faculty of Pharmacy and Macedonian Pharmaceutical Association, 2012-01-01T00:00:00Z.
• Fáttát: article
• Liŋkkat: Connect to this object online.

Generic industry aims to produce safe, efficient, built-in quality medicines that will satisfy patients' requirements and will be competitive on the market. In this paper, assessment of the need for quality by design (QbD) and process analytical technology (PAT) implementation by generic indust...