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

被引:11
|
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
BRAZILIAN JOURNAL OF ANALYTICAL CHEMISTRY | 2021年 / 8卷 / 30期
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
  • [31] A step forward towards the development of stable freeze-dried liposomes: a quality by design approach (QbD)
    Sylvester, Bianca
    Porfire, Alina
    Achim, Marcela
    Rus, Lucia
    Tomuta, Ioan
    DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY, 2018, 44 (03) : 385 - 397
  • [32] APPLICATION OF QUALITY BY DESIGN (QBD) IN FORMULATION DEVELOPMENT OF IMMEDIATE AND EXTENDED RELEASE BILAYERED TABLETS OF DEXTROMETHORPHAN AS A MODEL
    Nadeem, Mohd
    Babu, M. Suresh
    INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES, 2014, 1 (06): : 439 - 447
  • [33] Implementation of analytical quality-by-design and green analytical chemistry approaches for the development of robust and ecofriendly UHPLC analytical method for quantification of chrysin
    Sharma, Teenu
    Jain, Atul
    Saini, Sumant
    Katare, O. P.
    Singh, Bhupinder
    SEPARATION SCIENCE PLUS, 2020, 3 (09) : 384 - 398
  • [34] Development and Application of Analytical Methods for Chiral Amino Acids and Related Metabolites
    Karakawa, Sachise
    Harada, Masashi
    Nishimoto, Rumi
    CHROMATOGRAPHY, 2023, 44 (01) : 21 - 26
  • [35] Development and optimization of beer containing malted and non-malted substitutes using quality by design (QbD) approach
    Estevao, Simone Tessarini
    de Almeida e Silva, Joao Batista
    Lourenco, Felipe Rebello
    JOURNAL OF FOOD ENGINEERING, 2021, 289
  • [36] Applications of mixture experiments for response surface methodology implementation in analytical methods development
    Azcarate, Silvana M.
    Pinto, Licarion
    Goicoechea, Hector C.
    JOURNAL OF CHEMOMETRICS, 2020, 34 (12)
  • [37] Development of Theranostic Perfluorocarbon Nanoemulsions as a Model Non-Opioid Pain Nanomedicine Using a Quality by Design (QbD) Approach
    Herneisey, Michele
    Liu, Lu
    Lambert, Eric
    Schmitz, Nicholas
    Loftus, Shannon
    Janjic, Jelena M.
    AAPS PHARMSCITECH, 2019, 20 (02)
  • [38] Development of Theranostic Perfluorocarbon Nanoemulsions as a Model Non-Opioid Pain Nanomedicine Using a Quality by Design (QbD) Approach
    Michele Herneisey
    Lu Liu
    Eric Lambert
    Nicholas Schmitz
    Shannon Loftus
    Jelena M. Janjic
    AAPS PharmSciTech, 20
  • [39] Development of a Resveratrol Nanosuspension Using the Antisolvent Precipitation Method without Solvent Removal, Based on a Quality by Design (QbD) Approach
    Kuk, Do-Hoon
    Ha, Eun-Sol
    Ha, Dong-Hyun
    Sim, Woo-Yong
    Lee, Seon-Kwang
    Jeong, Ji-Su
    Kim, Jeong-Soo
    Baek, In-hwan
    Park, Heejun
    Choi, Du Hyung
    Yoo, Jin-Wook
    Jeong, Seong Hoon
    Hwang, Sung-Joo
    Kim, Min-Soo
    PHARMACEUTICS, 2019, 11 (12)
  • [40] Developing an Improved UHPLC Method for Efficient Determination of European Pharmacopeia Process-Related Impurities in Ropinirole Hydrochloride Using Analytical Quality by Design Principles
    Tome, Tim
    Obreza, Ales
    Casar, Zdenko
    MOLECULES, 2020, 25 (11):