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Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment

Само за регистроване кориснике
2017
Аутори
Đuriš, Jelena
Đurić, Zorica
Чланак у часопису (Објављена верзија)
Метаподаци
Приказ свих података о документу
Апстракт
Mathematical models can be used as an integral part of the quality by design (QbD) concept throughout the product lifecycle for variety of purposes, including appointment of the design space and control strategy, continual improvement and risk assessment. Examples of different mathematical modeling techniques (mechanistic, empirical and hybrid) in the pharmaceutical development and process monitoring or control are provided in the presented review. In the QbD context, mathematical models are predominantly used to support design space and/or control strategies. Considering their impact to the final product quality, models can be divided into the following categories: high, medium and low impact models. Although there are regulatory guidelines on the topic of modeling applications, review of QbDbased submission containing modeling elements revealed concerns regarding the scale-dependency of design spaces and verification of models predictions at commercial scale of manufacturing, especia...lly regarding real-time release (RTR) models. Authors provide critical overview on the good modeling practices and introduce concepts of multiple-unit, adaptive and dynamic design space, multivariate specifications and methods for process uncertainty analysis. RTR specification with mathematical model and different approaches to multivariate statistical process control supporting process analytical technologies are also presented.

Кључне речи:
Quality by design / Mathematical modeling / Design space / Control strategy / Pharmaceutical manufacturing / Real-time release
Извор:
International Journal of Pharmaceutics, 2017, 533, 2, 346-356
Издавач:
  • Elsevier Science BV, Amsterdam
Финансирање / пројекти:
  • Развој производа и технологија које обезбеђују жељено ослобађање лековитих супстанци из чврстих фармацеутских облика (RS-34007)

DOI: 10.1016/j.ijpharm.2017.05.070

ISSN: 0378-5173

PubMed: 28579542

WoS: 000414188500004

Scopus: 2-s2.0-85020452915
[ Google Scholar ]
38
31
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/2884
Колекције
  • Radovi istraživača / Researchers’ publications
Институција/група
Pharmacy
TY  - JOUR
AU  - Đuriš, Jelena
AU  - Đurić, Zorica
PY  - 2017
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2884
AB  - Mathematical models can be used as an integral part of the quality by design (QbD) concept throughout the product lifecycle for variety of purposes, including appointment of the design space and control strategy, continual improvement and risk assessment. Examples of different mathematical modeling techniques (mechanistic, empirical and hybrid) in the pharmaceutical development and process monitoring or control are provided in the presented review. In the QbD context, mathematical models are predominantly used to support design space and/or control strategies. Considering their impact to the final product quality, models can be divided into the following categories: high, medium and low impact models. Although there are regulatory guidelines on the topic of modeling applications, review of QbDbased submission containing modeling elements revealed concerns regarding the scale-dependency of design spaces and verification of models predictions at commercial scale of manufacturing, especially regarding real-time release (RTR) models. Authors provide critical overview on the good modeling practices and introduce concepts of multiple-unit, adaptive and dynamic design space, multivariate specifications and methods for process uncertainty analysis. RTR specification with mathematical model and different approaches to multivariate statistical process control supporting process analytical technologies are also presented.
PB  - Elsevier Science BV, Amsterdam
T2  - International Journal of Pharmaceutics
T1  - Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment
VL  - 533
IS  - 2
SP  - 346
EP  - 356
DO  - 10.1016/j.ijpharm.2017.05.070
ER  - 
@article{
author = "Đuriš, Jelena and Đurić, Zorica",
year = "2017",
abstract = "Mathematical models can be used as an integral part of the quality by design (QbD) concept throughout the product lifecycle for variety of purposes, including appointment of the design space and control strategy, continual improvement and risk assessment. Examples of different mathematical modeling techniques (mechanistic, empirical and hybrid) in the pharmaceutical development and process monitoring or control are provided in the presented review. In the QbD context, mathematical models are predominantly used to support design space and/or control strategies. Considering their impact to the final product quality, models can be divided into the following categories: high, medium and low impact models. Although there are regulatory guidelines on the topic of modeling applications, review of QbDbased submission containing modeling elements revealed concerns regarding the scale-dependency of design spaces and verification of models predictions at commercial scale of manufacturing, especially regarding real-time release (RTR) models. Authors provide critical overview on the good modeling practices and introduce concepts of multiple-unit, adaptive and dynamic design space, multivariate specifications and methods for process uncertainty analysis. RTR specification with mathematical model and different approaches to multivariate statistical process control supporting process analytical technologies are also presented.",
publisher = "Elsevier Science BV, Amsterdam",
journal = "International Journal of Pharmaceutics",
title = "Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment",
volume = "533",
number = "2",
pages = "346-356",
doi = "10.1016/j.ijpharm.2017.05.070"
}
Đuriš, J.,& Đurić, Z.. (2017). Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment. in International Journal of Pharmaceutics
Elsevier Science BV, Amsterdam., 533(2), 346-356.
https://doi.org/10.1016/j.ijpharm.2017.05.070
Đuriš J, Đurić Z. Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment. in International Journal of Pharmaceutics. 2017;533(2):346-356.
doi:10.1016/j.ijpharm.2017.05.070 .
Đuriš, Jelena, Đurić, Zorica, "Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment" in International Journal of Pharmaceutics, 533, no. 2 (2017):346-356,
https://doi.org/10.1016/j.ijpharm.2017.05.070 . .

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