Results 11 to 20 of about 62,558,702 (211)
Application of quality by design in the current drug development [PDF]
Asian Journal of Pharmaceutical Sciences, 2017 Quality by Test was the only way to guarantee quality of drug products before FDA launched current Good Manufacturing Practice. To clearly understand the manufacture processes, FDA generalized Quality by Design (QbD) in the field of pharmacy, which is ...
Lan Zhang, Shirui Mao
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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 +4 more
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Quality by design (QbD) for pharmaceutical area [PDF]
, 2015 Recent changes and limited resources for drug development and manufacturing have rendered the conventional pharmaceutical quality assurance approach insufficient and have given rise to new research in these areas. To address these research efforts, the FDA improved and modernized the rules governing pharmaceutical manufacturing and product quality in ...
Aksu, Buket, Mesut, Burcu
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A Review on Quality by Design Approach (QBD) for Pharmaceuticals
Journal of Drug Delivery and Therapeutics, 2019 Quality by Design is the modern approach for quality of pharmaceuticals. It describes use of Quality by Design to ensure quality of Pharmaceuticals. In this review, the Quality by Design is described and some of its elements identified. Process parameters and quality attributes are identified for each unit operation.
Pallavi U. Jadhav +5 more
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Quality by Design (QbD) como ferramenta para otimização dos processos farmacêuticos
Infarma: Pharmaceutical Sciences, 2017 O setor farmacêutico está em constante evolução. A harmonização de normas de produção, com o intuído de garantir eficácia, segurança e qualidade dos medicamentos, consiste em um dos maiores desafios. O conceito “qualidade baseada no projeto” (Quality by
Mariana Palmeira BEZERRA +1 more
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Mitigating the Risks of Generic Drug Product Development: An Application of Quality by Design (QbD) and Question based Review (QbR) Approaches. [PDF]
Journal of Excipients and Food Chemicals, 2016 This paper discusses the challenges and advantages of implementing Quality by Design (QbD) and Question based Review (QbR) when developing solid dosage formulations and manufacturing processes for generic drugs.
Manjurul Kader
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408 Quality by Design: A Framework for Study Success
Journal of Clinical and Translational Science, 2023 OBJECTIVES/GOALS: The SC CTSI Quality by Design (QbD) program aims to improve the execution of clinical research studies identifying and addressing possible issues before implementation.
Allison Orechwa +2 more
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Analytical QBD Approach to Redefine the Quality of Pharmaceuticals: A Review
Journal of Pharmaceutical Research, 2023 As per the present scenario traditional techniques of quality by testing of finished pharmaceutical products have proved to be unsatisfactory, although focus on 'Total quality assurance can be attained only by in-process testing and analysis ...
Shaik Ayesha Ameen, Nagaraju Pappula
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Quality by design based development of nanostructured lipid carrier: a risk based approach
Exploration of Medicine, 2022 The aim of this review is to discuss the development of nanostructured lipid carrier (NLC) by the application of quality by design (QbD). QbD started with the evolution of the quality concept and slow adaptation of quality guidelines, which has now ...
Tausif Alam
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Process Optimization and DOE Application in the Synthesis of Rociletinib Intermediate [PDF]
Chemical and Biochemical Engineering Quarterly, 2018 Critical step of Rociletinib synthesis, regioselective nucleophilic aromatic substitution of C-2 chlorine at pyrimidine molecule 3 with amine 2, was optimised by implementation of pre-DoE screening and DoE-based algorithms.
S. Kapić +3 more
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