Results 81 to 90 of about 6,391 (215)

QUALITY BY DESIGN (QbD) on CLINICAL TRIALS ACTIVITIES – A REVIEW

, 2023
Pharmaceutical industry is constantly looking for ways to ensure and enhance product safety, quality and efficacy. However, drug recalls, manufacturing failure costs, scale up issues and regulatory burden in recent past suggest otherwise.
Mr. V. S. Chandrasekaran, Miss. Syed Arshiya Sultana*, Dr. M. Kishore Babu
core   +1 more source

Integration of quality by design with artificial intelligence/machine learning technologies in pharmaceutical manufacturing: A comprehensive review

ADMET and DMPK
Background and purpose: Quality by design (QbD) has revolutionized pharmaceutical development by shifting from a conventional quality-by-testing approach to a science-based approach that incorporates quality into products and processes from inception ...
Sumit Ghosal, Niranjan Panda, Bikash Ranjan Jena, Madhusudan Maity, Sankhadip Bose, Rabinarayan Parhi   +5 more
doaj   +1 more source

Farmasötik ürünlerin geliştirilmesinde tasarımla kalite (QbD) yaklaşımının değerlendirilmesi ve QbD gerekliliklerine göre ruhsat dosyasının hazırlanması

, 2017
Farmasötik alanda Tasarımla Kalite (QbD) yaklaşımı, ilaç üretim prosesinin anlaşılmasını ve sürekli iyileştirmeyi amaçlamayan uygulamalar bütünüdür. QbD ile birlikte proses girdileri ve kritik kalite özellikleri arasında ilişki kurularak tasarım sahası
ZÜMRÜT YAR
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QbD: The cost of doing business

International Journal of Pharmaceutical Excipients, 2016
The premise of the current iteration of QbD focusing unduly on canned compliance using an unsuitable statistical model, of not adding anything to the bottom line, of not rewarding better processes and quality and not lending itself to the scientific building of quality into the product does not make it a particularly desirable entity ...
openaire   +2 more sources

Application of the Quality-by-Design Approach at the Laboratory Stage of Tablet Development

Регуляторные исследования и экспертиза лекарственных средств
INTRODUCTION. Quality by design (QbD) is a systematic approach to pharmaceu­tical development that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management.
M. V. Karlina, V. M. Kosman, M. N. Makarova, V. G. Makarov   +3 more
doaj   +1 more source

QbD-driven development and validation of an efficient bioanalytical UPLC method for estimation of olmesartan medoxomil

, 2016
The present studies describe quality by design-based development of bioanalytical ultra performance liquid chromatography method of olmesartan medoxomil.
Ranjot Kaur (2890523), Bhupinder Singh (443885), O. P. Katare (2890526), Sarwar Beg (807235), Sagar Suman Panda (2890520), Atul Jain (827616)   +5 more
core   +1 more source

Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD)

Brazilian Journal of Pharmaceutical Sciences, 2018
According to Quality by Design (QbD) concept, quality should be built into product/method during pharmaceutical/analytical development. Usually, there are many input factors that may affect quality of product and methods. Recently, Design of Experiments (
Isa Martins Fukuda, Camila Francini Fidelis Pinto, Camila dos Santos Moreira, Alessandro Morais Saviano, Felipe Rebello Lourenço   +4 more
doaj   +1 more source

Analytical quality-by-design approach for sample treatment of BSA-containing solutions

Journal of Pharmaceutical Analysis, 2015
The sample preparation of samples containing bovine serum albumin (BSA), e.g., as used in transdermal Franz diffusion cell (FDC) solutions, was evaluated using an analytical quality-by-design (QbD) approach.
Lien Taevernier, Evelien Wynendaele, Matthias D׳Hondt, Bart De Spiegeleer   +3 more
doaj   +1 more source

Review on Pharmaceutical Quality by Design (QbD)

Asian Journal of Pharmaceutical Research and Development, 2019
Pharmaceutical Quality by Design (QBD) is a systematic approach to development that begins with predetermined objectives and emphasizes the understanding of production and processes and process control, based on sound science and quality risk management. Quality purchasing design (QBD) is emerging to increase the promise of providing safe and effective
Mukesh Sharma, Shankar Lal Soni, Saumya Shrivastava, Rahul Ancheria, Deepak Deepak Kumar   +4 more
openaire   +2 more sources

Desarrollo de una metodología basada en la gestión del conocimiento para la apropiación de la filosofía QUALITY BY DESIGN (QBD) en empresas del sector cosmético colombiano [PDF]

, 2017
Se presenta una propuesta metodológica para implementar la filosofía Quality by Design (Calidad desde el diseño) en empresas del sector cosmético colombiano, tomando como elemento orientador los principios de la Gestión del Conocimiento.
García Aponte, Oscar Fabián
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