Quality by design for pharmaceuticals
Anita Anand
Broschiertes Buch

Quality by design for pharmaceuticals

Netillimicin qbd

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ICH guidelines specify the pharmaceuticals intended for human use in the category of Q 8,10,11 for the efficacy quality and safety of the intended product are in sync with the Quality by Design (QbD) principles, as quality by design is a risk-based approach with pure scientific logics to establish a quality target product profile[1]. The spectroscopic method approach for analysis of netilmicin was performed as per ICH Q8 (R2) guidelines. Quality by Design (QbD) was also incorporated by derivatization for which absorption spectra and absorption maxima were used, making it very simple and inexpe...