Drilling into “Quality by Design” Approach for Analytical Methods

Author:

Chiarentin Lucas123ORCID,Gonçalves Carla2,Augusto Cátia2,Miranda Margarida24,Cardoso Catarina2,Vitorino Carla13

Affiliation:

1. Faculty of Pharmacy, University of Coimbra, Coimbra, Portugal

2. Laboratórios Basi Indústria Farmacêutica S.A, Parque Industrial Manuel Lourenço Ferreira, Mortágua, Portugal

3. Coimbra Chemistry Centre, Institute of Molecular Sciences - IMS, Department of Chemistry, University of Coimbra, Coimbra, Portugal

4. Egas Moniz School of Health and Science, Egas Moniz Center of Interdisciplinary Research (CiiEM), Caparica, Portugal

Funder

Fundação para a Ciência e a Tecnologia (FCT), Portugal and Laboratórios Basi Indústria Farmacêutica S.A. from Drugs R&D Doctoral Program

Publisher

Informa UK Limited

Subject

Analytical Chemistry

Reference237 articles.

1. QbD Innovation Through Advances in PAT, Data Analysis Methodologies, and Material Characterization

2. FDA. GMP’s for the 21st Century. Department of Health and Human Services: Silver Spring, MD, 2004, pp 1–32.

3. FDA. Guidance for Industry, PAT-A Framework for Innovative Pharmaceutical Development. Manufacturing and Quality Assurance: Silver Spring, MD, 2004.

4. A state of the art in analytical quality-by-design and perspectives in characterization of nano-enabled medicinal products

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