Key Information Related to Quality by Design (QbD) Applications in Analytical Methods Development

被引:10
|
作者
Araujo, Alisson Silva [1 ]
Andrade, Daniel Fernandes [1 ]
Babos, Diego Victor [1 ]
Castro, Jeyne Pricylla [1 ]
Garcia, Jose Augusto [1 ]
Speranca, Marco Aurelio [2 ]
Gamela, Raimundo Rafael [1 ]
Machado, Raquel Cardoso [1 ]
Costa, Vinicius Camara [3 ]
Guedes, Wesley Nascimento [2 ]
Pereira-Filho, Edenir Rodrigues [1 ]
Verbi Pereira, Fabiola Manhas [2 ,4 ]
机构
[1] Univ Fed Sao Carlos UFSCar, Dept Quim, Grp Anal Instrumental Aplicada GAIA, BR-13565905 Sao Carlos, SP, Brazil
[2] Univ Estadual Paulista Unesp, Inst Quim, Inst Pesquisa Bioenergia IPBEN, Grp Abordagens Analit Alternat GAAA, BR-14800060 Araraquara, SP, Brazil
[3] Univ Fed Espirito Santo UFES, Dept Quim, LabPetro, Lab Espectrometria Atom LEA, BR-29075910 Vitoria, ES, Brazil
[4] Inst Nacl Tecnol Alternat Deteccao Avaliacao Toxi, BR-14800060 Araraquara, SP, Brazil
来源
基金
巴西圣保罗研究基金会;
关键词
chemometrics; quality by design; control strategy; design of experiments; analytical chemistry in industrial applications; PERFORMANCE LIQUID-CHROMATOGRAPHY; MULTIVARIATE OPTIMIZATION TECHNIQUES; RESPONSE-SURFACE METHODOLOGY; STABILITY-INDICATING METHOD; RP-HPLC METHOD; BY-DESIGN; FACTORIAL DESIGN; PLACKETT-BURMAN; ANALYTICAL-CHEMISTRY; MICROPLATE BIOASSAY;
D O I
10.30744/brjac.2179-3425.RV-27-2020
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
In this review, quality by design (QbD) initiatives are described as applications for many types of processes, such as in the pharmaceutical industry, biotechnology field, and for analytical methods development. Design space (DS) and design of experiments (DoE) provide useful results for analytical methods development and simulation of advanced processes in traditional manufacturing relationships. The three topics, QbD, DS and DoE are the best way to achieve strong and efficient industrial production.
引用
收藏
页码:14 / 28
页数:15
相关论文
共 50 条
  • [1] Development of Quality-By-Design Analytical Methods
    Vogt, Frederick G.
    Kord, Alireza S.
    [J]. JOURNAL OF PHARMACEUTICAL SCIENCES, 2011, 100 (03) : 797 - 812
  • [2] Development and Validation of a Microplate Bioassay for Nystatin Using Analytical Quality by Design (QbD) Approach
    Jamil, Carmen R. P.
    Lourenco, Felipe R.
    Ghisleni, Daniela D. M.
    Pinto, Terezinha J. A.
    [J]. LATIN AMERICAN JOURNAL OF PHARMACY, 2016, 35 (08): : 1871 - 1876
  • [3] Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD)
    Fukuda, Isa Martins
    Fidelis Pinto, Camila Francini
    Moreira, Camila dos Santos
    Saviano, Alessandro Morais
    Lourenco, Felipe Rebello
    [J]. BRAZILIAN JOURNAL OF PHARMACEUTICAL SCIENCES, 2018, 54
  • [4] QUALITY BY DESIGN APPLICATIONS TO ANALYTICAL METHODS IN THE PHARMACEUTICAL INDUSTRY
    Kenett, Ron S.
    Kenett, Dan A.
    [J]. ADVANCED MATHEMATICAL AND COMPUTATIONAL TOOLS IN METROLOGY AND TESTING VIII, 2009, 78 : 183 - +
  • [5] Quality by design (QbD), Process Analytical Technology (PAT), and design of experiment applied to the development of multifunctional sunscreens
    Peres, Daniela D'Almeida
    Ariede, Maira Bueno
    Candido, Thalita Marcilio
    de Almeida, Tania Santos
    Lourenco, Felipe Rebello
    Consiglieri, Vladi Olga
    Kaneko, Telma Mary
    Robles Velasco, Maria Valeria
    Baby, Andre Rolim
    [J]. DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY, 2017, 43 (02) : 246 - 256
  • [6] Application of quality by design to the development of analytical separation methods
    Orlandini, Serena
    Pinzauti, Sergio
    Furlanetto, Sandra
    [J]. ANALYTICAL AND BIOANALYTICAL CHEMISTRY, 2013, 405 (2-3) : 443 - 450
  • [7] Application of quality by design to the development of analytical separation methods
    Serena Orlandini
    Sergio Pinzauti
    Sandra Furlanetto
    [J]. Analytical and Bioanalytical Chemistry, 2013, 405 : 443 - 450
  • [8] Quality by Design (QbD) application for the pharmaceutical development process
    Sang-Ho Lee
    Jin-Ki Kim
    Jun-Pil Jee
    Dong-Jin Jang
    Young-Joon Park
    Joo-Eun Kim
    [J]. Journal of Pharmaceutical Investigation, 2022, 52 : 649 - 682
  • [9] Quality by Design (QbD) application for the pharmaceutical development process
    Lee, Sang-Ho
    Kim, Jin-Ki
    Jee, Jun-Pil
    Jang, Dong-Jin
    Park, Young-Joon
    Kim, Joo-Eun
    [J]. JOURNAL OF PHARMACEUTICAL INVESTIGATION, 2022, 52 (06) : 649 - 682
  • [10] Examining the basic principles of quality by design (QbD) approach in analytical studies
    Mesut, Burcu
    Onal, Cem
    Aksu, Buket
    Ozsoy, Yildiz
    [J]. ISTANBUL JOURNAL OF PHARMACY, 2021, 51 (02): : 271 - 276