Results 91 to 100 of about 6,391 (215)
, 2023 O Quality by Design (QbD) é uma metodologia que procura garantir a qualidade dos produtos por meio do controle de todo o processo produtivo, desde o desenvolvimento até a fabricação e controle de qualidade.
Macedo, Mariana Duarte Ferreira [UNIFESP]
core
From lab to industrial development of lipid nanocarriers using quality by design approach
International Journal of Pharmaceutics: XLipid nanocarriers have attracted a great deal of interest in the delivery of therapeutic molecules. Despite their many advantages, compliance with quality standards and reproducibility requirements still constrain their industrial production.
Aristote B. Buya +2 more
doaj +1 more source
Double Your Pleasure: Computer Model Defines QbD
Model of QbD including PAT, Risk, and Design Space ...
Ronald Fuqua, S. Weinberg
core +1 more source
The component queues method for QBD process fitting and analysis
Markovian queueing analysis requires fitting models of arrival and service processes, such as phase-type (PH) distributions, to accurately represent system measurements.
Bor, Julianna +2 more
core +2 more sources
Quality by Design (QbD) is a systematic, science-based approach to pharmaceutical development that emphasizes understanding the product and process, and controlling variability to ensure predefined quality outcomes. Unlike traditional quality control methods, QbD integrates quality into the design of processes and products from the early stages of ...
openaire +2 more sources
Биопрепараты: Профилактика, диагностика, лечениеINTRODUCTION. Currently, manufacturers of adeno-associated virus (AAV)-based gene therapy products are facing a number of systemic problems stemming from the difficulties in assessing the quality of medicinal products due to insufficient scientific data,
D. S. Kopein +2 more
doaj +1 more source
Roadmap Design for Implementing QbD in Generic Drug Engineering [PDF]
, 2014 全球制药行业正处于“专利悬崖”期，市场上有大量的品牌药将失去独家专利权。把握这次历史性的机遇，选择专利逾期的畅销药品，提高生产效率和产品质量水平、降低生产成本和产品次品率这些问题受到我国制药厂商的广泛关注。在质量源于设计（QualitybyDesign,QbD）这种以科学和风险为基础的确保产品质量的方法和理念已经在制药行业内获得普遍认同的背景下，本文的研究目的是在实施仿制药应用QbD时，设计整体路径和主要内容。路径设计依据现有的QbD一般原则，由五个阶段组成，包含了工艺理解、设计和提升三个方面内容 ...
刘理文
core
Triangular M/G/1-type and tree-like QBD Markov chains [PDF]
, 2009 In applying matrix-analytic methods to M/G/1-type and tree-like QBD Markov chains, it is crucial to determine the solution to a (set of) nonlinear matrix equation(s). This is usually done via iterative methods.
Van Houdt, B., Leeuwaarden, van, J.S.H.
core +1 more source
, 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
Yar, Zümrüt
core
The quality-by-design (QbD) approach is widely utilized for developing and validating manufacturing processes for drug substances as well as drug products. This paper discusses the application of the risk-based QbD approach used at F.
Daniel Coleman (280108) +11 more
core +1 more source