Výsledky vyhledávání - "Critical process parameter"

Identification of critical process parameters and quality attributes for bioreactor-based expansion of human MSCs

Autoři: Herbst, Laura Nießing, Bastian Schmitt, Robert H.

Zdroj: Frontiers in Bioengineering and Biotechnology. 13

Témata: Quality-by-design, Bioreactor, Critical quality attributes, Mesenchymal stem cells, Critical process parameter, Standardization

Critical evaluation of quality by design software

Autoři: Reddy, Daram Sushma Kumar, Vadla Pranay Shyam, Thalaari a další

Témata: Quality By Design, Design of Experiments, Critical Process Parameter (CPP), Target Product Quality Profile (TPQP), Target Product Profile (TPP)

Advanced QbD-Based Process Optimization of Clopidogrel Tablets with Insights into Industrial Manufacturing Design

Autoři: Young Woo Bak Mi Ran Woo Hyuk Jun Cho a další

Zdroj: Pharmaceutics, Vol 17, Iss 5, p 659 (2025)

Témata: clopidogrel, quality by design, critical quality attribute, intermediate critical quality attribute, critical process parameter, control strategy, Pharmacy and materia medica, RS1-441

Popis souboru: electronic resource

Relation: https://www.mdpi.com/1999-4923/17/5/659; https://doaj.org/toc/1999-4923

Přístupová URL adresa: https://doaj.org/article/a82ac62324fb4be08c4eee88acaaee84

Sustainability and quality-by-design of an integrated end-to-end continuous pharmaceutical plant [Abstract]

Autoři: Tim Campbell Chris Rielly Brahim Benyahia

Témata: Integrated Continuous Pharmaceutical Plant, Global Sensitivity Analysis, Estimability, Critical Process Parameter, Quality-by-Design, Design Space, Analytical Hierarchy Process, Sustainability

Relation: 2134/26049688.v1

Dostupnost: https://figshare.com/articles/conference_contribution/Sustainability_and_quality-by-design_of_an_integrated_end-to-end_continuous_pharmaceutical_plant_Abstract_/26049688

Pichia pastoris Cell Disruption by High-Pressure Homogenization (HPH).

Autoři: Casablancas, Antoni Garcia-Ortega, Xavier Valero, Francisco

Zdroj: Methods Mol Biol ; ISSN:1940-6029 ; Volume:2697

Témata: Cell disruption, Critical process parameter (CPP), High-pressure homogenization, Key performance indicators (KPI), Komagataella phaffii, Pichia pastoris

Relation: https://doi.org/10.1007/978-1-0716-4779-0_41; https://pubmed.ncbi.nlm.nih.gov/41028492

Dostupnost: https://doi.org/10.1007/978-1-0716-4779-0_41
https://pubmed.ncbi.nlm.nih.gov/41028492

Pharmaceutical Product Development: Quality by Design (QbD)

Autoři: Valeru, Chintu

Zdroj: UPI Journal of Pharmaceutical, Medical and Health Sciences; Volume-7, Issue-3, 2024; 11-16 ; 2581-4532

Témata: Quality by Design (QbD), ICH Guidelines, Target Product Quality Profile (TPQP), Critical Quality Attribute (CQA), Critical Process Parameter (CPP), Quality Risk Management (QRM)

Popis souboru: application/pdf

Relation: https://uniquepubinternational.com/journals/index.php/jpmhs/article/view/115/106; https://uniquepubinternational.com/journals/index.php/jpmhs/article/view/115

Dostupnost: https://uniquepubinternational.com/journals/index.php/jpmhs/article/view/115

An Approach for in-Line Control of Moisture Content During Green Tea Processing

Autoři: Zhangfeng Zhao Lun Chen Guoda Chen a další

Zdroj: IEEE Access, Vol 8, Pp 59701-59714 (2020)

Témata: tea, 0404 agricultural biotechnology, design space, rough set, Critical process parameter, Electrical engineering. Electronics. Nuclear engineering, 04 agricultural and veterinary sciences, 0405 other agricultural sciences, multivariate method, moisture content, TK1-9971

Přístupová URL adresa: https://ieeexplore.ieee.org/ielx7/6287639/8948470/09045938.pdf
https://doaj.org/article/944ea1c9685f44d7aa9107cded9fcb02

Satisfying QTPP of Erythropoietin Biosimilar by QbD through DoE-Derived Downstream Process Engineering

Autoři: Kakon Nag Enamul Haq Sarker Samir Kumar a další

Zdroj: Pharmaceutics, Vol 15, Iss 2087, p 2087 (2023)

Témata: erythropoietin, biosimilar, critical process parameter (CPP), design of experiment (DoE), purification, quality by design (QbD), Pharmacy and materia medica, RS1-441

Relation: https://www.mdpi.com/1999-4923/15/8/2087; https://doaj.org/toc/1999-4923; https://doaj.org/article/10e419586d3946b98e8a88780e1960ef

Dostupnost: https://doi.org/10.3390/pharmaceutics15082087
https://doaj.org/article/10e419586d3946b98e8a88780e1960ef

Data Sheet 1_Identification of critical process parameters and quality attributes for bioreactor-based expansion of human MSCs.pdf

Autoři: Laura Herbst Bastian Nießing Robert H. Schmitt

Témata: Biotechnology, quality-by-design, critical process parameter, critical quality attributes, mesenchymal stem cells, standardization, bioreactor

Dostupnost: https://doi.org/10.3389/fbioe.2025.1608194.s001
https://figshare.com/articles/dataset/Data_Sheet_1_Identification_of_critical_process_parameters_and_quality_attributes_for_bioreactor-based_expansion_of_human_MSCs_pdf/29956661

Data Sheet 2_Identification of critical process parameters and quality attributes for bioreactor-based expansion of human MSCs.pdf

Autoři: Laura Herbst Bastian Nießing Robert H. Schmitt

Témata: Biotechnology, quality-by-design, critical process parameter, critical quality attributes, mesenchymal stem cells, standardization, bioreactor

Dostupnost: https://doi.org/10.3389/fbioe.2025.1608194.s002
https://figshare.com/articles/dataset/Data_Sheet_2_Identification_of_critical_process_parameters_and_quality_attributes_for_bioreactor-based_expansion_of_human_MSCs_pdf/29956637

Data Sheet 3_Identification of critical process parameters and quality attributes for bioreactor-based expansion of human MSCs.pdf

Autoři: Laura Herbst Bastian Nießing Robert H. Schmitt

Témata: Biotechnology, quality-by-design, critical process parameter, critical quality attributes, mesenchymal stem cells, standardization, bioreactor

Dostupnost: https://doi.org/10.3389/fbioe.2025.1608194.s003
https://figshare.com/articles/dataset/Data_Sheet_3_Identification_of_critical_process_parameters_and_quality_attributes_for_bioreactor-based_expansion_of_human_MSCs_pdf/29956601

Data Sheet 4_Identification of critical process parameters and quality attributes for bioreactor-based expansion of human MSCs.pdf

Autoři: Laura Herbst Bastian Nießing Robert H. Schmitt

Témata: Biotechnology, quality-by-design, critical process parameter, critical quality attributes, mesenchymal stem cells, standardization, bioreactor

Dostupnost: https://doi.org/10.3389/fbioe.2025.1608194.s004
https://figshare.com/articles/dataset/Data_Sheet_4_Identification_of_critical_process_parameters_and_quality_attributes_for_bioreactor-based_expansion_of_human_MSCs_pdf/29956580

Process Validation of Highly Potent Antidiabetic Tablets of Voglibose 0.2 Mg

Autoři: Tijare, Lokesh K. Deshmukh, Lokesh T. Mohod, Abhinay A. a další

Zdroj: Asian Journal of Pharmaceutical Research and Development; Vol. 10 No. 2 (2022): Vol 10 No 2 (2022): Vol 10 No (2022): Volume 10 Issue 2 March - April. 2022; 90-110 ; 2320-4850

Témata: Voglibose 0.2 mg, Critical process parameter, Critical quality attributes, Process capability index

Popis souboru: application/pdf

Relation: http://ajprd.com/index.php/journal/article/view/1070/1159; http://ajprd.com/index.php/journal/article/view/1070

Dostupnost: http://ajprd.com/index.php/journal/article/view/1070
https://doi.org/10.22270/ajprd.v10i2.1070

A Review on process validation of solid dosage form

Autoři: Vaja, Maulikkumar D Patel, Bhoomi D Patel, Krina A a další

Zdroj: Journal of Drug Delivery and Therapeutics; Vol. 11 No. 4 (2021): Volume 11, Issue 4, July-August 2021; 157-160 ; 2250-1177

Témata: Concurrent process validation, Process validation, Levonorgestrel, Critical process parameter

Popis souboru: application/pdf; text/html

Relation: http://jddtonline.info/index.php/jddt/article/view/4880/3973; http://jddtonline.info/index.php/jddt/article/view/4880/3974; http://jddtonline.info/index.php/jddt/article/view/4880

Dostupnost: http://jddtonline.info/index.php/jddt/article/view/4880
https://doi.org/10.22270/jddt.v11i4.4880

Process Characterization by Definitive Screening Design Approach on DNA Vaccine Production

Autoři: Lalintip Hocharoen Sarawuth Noppiboon Panit Kitsubun

Zdroj: Frontiers in Bioengineering and Biotechnology, Vol 8 (2020)

Témata: process characterization, DNA vaccine, definitive screening design, critical process parameter, critical quality attributes, Biotechnology, TP248.13-248.65

Popis souboru: electronic resource

Relation: https://www.frontiersin.org/article/10.3389/fbioe.2020.574809/full; https://doaj.org/toc/2296-4185

Přístupová URL adresa: https://doaj.org/article/50bd1219c9594911986b2086b54a861d

PROCESS VALIDATION OF SIMVASTATIN 20MG TABLETS

Autoři: Poonam Rana*, Pawana Mahar

Témata: validation, process validation, critical process parameter, validation plan

Relation: https://zenodo.org/records/3783634; oai:zenodo.org:3783634; https://doi.org/10.5281/zenodo.3783634

Dostupnost: https://doi.org/10.5281/zenodo.3783634
https://zenodo.org/records/3783634

Quantitative CPP Evaluation from Risk Assessment Using Integrated Process Modeling

Autoři: Daniel Borchert Thomas Zahel Yvonne E. Thomassen a další

Zdroj: Bioengineering ; Volume 6 ; Issue 4 ; Pages: 114

Témata: integrated process modeling, OOS estimation, simulation based on risk assessment, process knowledge, potential critical process parameter (pCPP) assessment, severity contribution, occurrence contribution

Popis souboru: application/pdf

Relation: https://dx.doi.org/10.3390/bioengineering6040114

Dostupnost: https://doi.org/10.3390/bioengineering6040114

Scale-Up Strategy in Quality by Design Approach for Pharmaceutical Blending Process with Discrete Element Method Simulation

Autoři: Su Bin Yeom Du Hyung Choi

Zdroj: Pharmaceutics, Vol 11, Iss 6, p 264 (2019)

Témata: discrete element method, quality by design, physics-based model, scale-up strategy, critical process parameter, process simulation, Pharmacy and materia medica, RS1-441

Relation: https://www.mdpi.com/1999-4923/11/6/264; https://doaj.org/toc/1999-4923; https://doaj.org/article/7de579aa790a40099f868baf37ed2053

Dostupnost: https://doi.org/10.3390/pharmaceutics11060264
https://doaj.org/article/7de579aa790a40099f868baf37ed2053

Defining Processing Times for Accelerator Produced 225 Ac and Other Isotopes from Proton Irradiated Thorium

Autoři: Jonathan Fitzsimmons Justin Griswold Dmitri Medvedev a další

Zdroj: Molecules, Vol 24, Iss 6, p 1095 (2019)

Témata: Isotope production, Actinium-225, Silver-111, MCNPX, Thorium, proton irradiation, fission products, Sr-82, critical process parameter, Organic chemistry, QD241-441

Relation: https://www.mdpi.com/1420-3049/24/6/1095; https://doaj.org/toc/1420-3049; https://doaj.org/article/f9c2891fca4546449b7119cff8dbddda

Dostupnost: https://doi.org/10.3390/molecules24061095
https://doaj.org/article/f9c2891fca4546449b7119cff8dbddda

The pharmaceutical quality revolution

Autoři: Jordi Botet

Zdroj: ScienceRise, Vol 1, Iss 4 (18), Pp 4-15 (2016)

Témata: Continual improvement, Critical Process Parameter (CPP), Critical Quality Attribute (CQA), Knowledge management, Lifecycle, Pharmaceutical Quality System (PQS), Quality by design (QbD), Quality risk management, Quality Target Product Profile (QTPP), Suppl, Science (General), Q1-390

Relation: http://journals.uran.ua/sciencerise/article/view/58866; https://doaj.org/toc/2313-6286; https://doaj.org/toc/2313-8416; https://doaj.org/article/068f98aea41b4a28a4d5e48674c9c211

Dostupnost: https://doi.org/10.15587/2313-8416.2016.58866
https://doaj.org/article/068f98aea41b4a28a4d5e48674c9c211