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

页码：14 / 28

页数：15

共 126 条

[1] D-optimal design as a useful tool response surface methodology for the optimization of signals from synchronous fluorescence prior to simultaneous determination of avanafil and tadalafil [J].

Abdel-Raoof, Ahmed M. ;

Said, Ragab A. M. ;

Emara, Mohamed S. ;

El-Desouky, Ebrahim A. ;

Abdelzaher, Ahmed M. ;

Hasan, Mohamed A. ;

Osman, Ayman E. .

SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY, 2020, 235 (235)

[2] Bioreactor Process Parameter Screening Utilizing a Plackett-Burman Design for a Model Monoclonal Antibody [J].

Agarabi, Cyrus D. ;

Schiel, John E. ;

Lute, Scott C. ;

Chavez, Brittany K. ;

Boyne, Michael T., II ;

Brorson, Kurt A. ;

Khan, Mansoor A. ;

Read, Erik K. .

JOURNAL OF PHARMACEUTICAL SCIENCES, 2015, 104 (06) :1919-1928

[3]

Agrawal VP, 2016, EURASIAN J ANAL CHEM, V11, P63

[4] Minimum aberration blocking of regular mixed factorial designs [J].

Ai, MY ;

Yang, GJ ;

Zhang, RC .

JOURNAL OF STATISTICAL PLANNING AND INFERENCE, 2006, 136 (04) :1493-1511

[5] Multivariate Optimization of Method of Slurry Sampling for Determination of Iron and Zinc in Starch Samples by Flame Atomic Absorption Spectrometry [J].

Amorim, Fabio A. C. ;

Costa, Vinicius C. ;

Guedes, Wesley N. ;

de Sa, Ivero P. ;

dos Santos, Mayara C. ;

da Silva, Erik G. P. ;

Lima, Daniel de C. .

FOOD ANALYTICAL METHODS, 2016, 9 (06) :1719-1725

[6] Reliability Evaluation of the Design Space of the Granulation Process of Mefenamic Acid Tablets Using a Bootstrap Resampling Technique [J].

Arai, Hiroaki ;

Suzuki, Tatsuya ;

Yada, Shuichi ;

Kaseda, Chosei ;

Onuki, Yoshinori ;

Takayama, Kozo .

CHEMICAL & PHARMACEUTICAL BULLETIN, 2011, 59 (05) :608-617

[7] A comprehensive factorial design study of variables affecting protein extraction from formalin-fixed kidney tissue samples [J].

Araujo, J. E. ;

Oliveira, E. ;

Otero-Glez, A. ;

Santos Nores, J. ;

Igrejas, G. ;

Lodeiro, C. ;

Capelo, J. L. ;

Santos, H. M. .

TALANTA, 2014, 119 :90-97

[8] Application of quality by design elements for the development and optimization of an analytical method for protamine sulfate [J].

Awotwe-Otoo, David ;

Agarabi, Cyrus ;

Faustino, Patrick J. ;

Habib, Muhammad J. ;

Lee, Sau ;

Khan, Mansoor A. ;

Shah, Rakhi B. .

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2012, 62 :61-67

[9] Optimization of a refolding step for a therapeutic fusion protein in the quality by design (QbD) paradigm [J].

Bade, Pratap D. ;

Kotu, Susmitha P. ;

Rathore, Anurag S. .

JOURNAL OF SEPARATION SCIENCE, 2012, 35 (22) :3160-3169

[10] Analytical Quality by Design (AQbD) as a multiaddressable platform for co-encapsulating drug assays [J].

Basso, Joao ;

Mendes, Maria ;

Cova, Tania F. G. G. ;

Sousa, Joao J. ;

Pais, Alberto A. C. C. ;

Vitorino, Carla .

ANALYTICAL METHODS, 2018, 10 (47) :5659-5671

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