Výsledky vyhledávání - "critical process parameters"

Application of the Quality-by-Design Approach at the Laboratory Stage of Tablet Development

Autoři: M. V. Karlina V. M. Kosman M. N. Makarova a další

Zdroj: Регуляторные исследования и экспертиза лекарственных средств, Vol 15, Iss 2, Pp 168-178 (2025)

Témata: quality target product profile, Medicine (General), R5-920, quality by design, laboratory stage, critical material parameters, dosage form, tablets, critical process parameters, critical quality attributes, production, pharmaceutical development

Přístupová URL adresa: https://doaj.org/article/65c3e1696d494654a8e4410181eaa6a4

Quality by Design-Guided Development of Hydrogel-Forming Microneedles for Transdermal Delivery of Enfuvirtide

Autoři: Huanhuan Li Lalitkumar K. Vora Qonita Anjani a další

Zdroj: ACS Appl Mater Interfaces
Li, H, Vora, L K, Anjani, Q, Abraham, A M, Cong, Y, Moreno-Castellanos, N, Ballana, E, Muñoz, E R, Nevot, M & Donnelly, R F 2025, 'Quality by design-guided development of hydrogel-forming microneedles for transdermal delivery of enfuvirtide', ACS Applied Materials & Interfaces, vol. 17, no. 18, pp. 26227-26251. https://doi.org/10.1021/acsami.5c00499

Témata: enfuvirtide, quality by design, design of experiment, Hydrogels, Enfuvirtide, Administration, Cutaneous, transdermal drug delivery, Drug Delivery Systems, Needles, critical process parameters, hydrogel-forming microneedles, Animals, critical quality attributes, critical material attributes

Popis souboru: application/pdf

Přístupová URL adresa: https://pubmed.ncbi.nlm.nih.gov/40063825
https://pure.qub.ac.uk/en/publications/8d0099db-4627-44b9-bd13-6fbb89f6c121

Optimizing viral transduction in immune cell therapy manufacturing: key process design considerations

Autoři: Liu Dan Lee Kang-Zheng

Zdroj: Journal of Translational Medicine, Vol 23, Iss 1, Pp 1-17 (2025)

Témata: Viral transduction, Cell therapy manufacturing, Critical process parameters (CPPs), Critical quality attributes (CQAs), Immune cell therapy, Medicine

Popis souboru: electronic resource

Relation: https://doaj.org/toc/1479-5876

Přístupová URL adresa: https://doaj.org/article/3d1490317af6426aac2de856c7e542af

Process Validation of Sitagliptin Film Coated Tablets 100 Mg

Autoři: Pratibha Thapliyal*, Neha Sodiyal, Shivanand Patil

Témata: Introduction, Sitagliptin, Process validation, Critical process parameters (CPPs), critical quality attributes (CQAs), and Regulatory guidelines of Process Validation

Implementation of QbD and preformulation characteristics of sublingual antihypertensive drug

Autoři: Joshi, Deepak Choudhary, Naveen K

Zdroj: Research Journal of Pharmacy and Technology 18(1):245-250. 2025

Quality by Design (QbD) in pharmaceutical development: A comprehensive review

Autoři: Pratik B. Aru Mayur S. Gulhane Vinayak A. Katekar a další

Zdroj: GSC Biological and Pharmaceutical Sciences. 26:328-340

Témata: Risk Management, International Conference on Harmonization (ICH), Global Harmonization, Empirical Methods, Predictability, Industry 4.0, Real-time Release Testing (RTRT), Critical Process Parameters (CPPs), Case Studies, Continuous Improvement, Regulatory Compliance, Critical Quality Attributes (CQAs), Consistency, Patient Safety, Advanced Technologies, Quality by Design (QBD) Pharmaceutical Development, Design Space, Paradigm Shift

Advancements in Pharmaceutical Lyophilization: Integrating QbD, AI, and Novel Formulation Strategies for Next-Generation Biopharmaceuticals

Autoři: Prachi Atre Syed A. A. Rizvi

Zdroj: Biologics ; Volume 5 ; Issue 4 ; Pages: 35

Témata: lyophilization, quality by design, artificial intelligence, critical process parameters, regulatory compliance, biologics stabilization

Popis souboru: application/pdf

Relation: https://dx.doi.org/10.3390/biologics5040035

Dostupnost: https://doi.org/10.3390/biologics5040035

Comparative Analysis of Real-Time Measurement Techniques in Pharmaceutical Manufacturing: Infra-Red Spectroscopy and Mass Spectroscopy

Autoři: Fudala, Szymon

Témata: Infrared (IR) Spectroscopy, Mass Spectrometry (MS), Analytical techniques, Pharmaceutical manufacturing, Quality control, Critical process parameters (CPPs), Critical quality attributes (CQAs)

Relation: https://zenodo.org/records/15756085; oai:zenodo.org:15756085; https://doi.org/10.5281/zenodo.15756085

Dostupnost: https://doi.org/10.5281/zenodo.15756085
https://zenodo.org/records/15756085

Process Validation of Sitagliptin Film Coated Tablets 100 Mg

Autoři: Pratibha Thapliyal* Neha Sodiyal Shivanand Patil

Témata: Introduction, Sitagliptin, Process validation, Critical process parameters (CPPs), critical quality attributes (CQAs), and Regulatory guidelines of Process Validation

Relation: https://zenodo.org/communities/ijpsjournal/; https://zenodo.org/records/15585613; oai:zenodo.org:15585613; https://doi.org/10.5281/zenodo.15585613

Dostupnost: https://doi.org/10.5281/zenodo.15585613
https://zenodo.org/records/15585613

Overcoming Scale-Dependent Impurity Escalation in Epalrestat Synthesis: Identification, Mechanistic Elucidation, and Robust Process Control

Autoři: Yao Feng Zhike Tian Jincheng Yang a další

Témata: Biophysics, Biochemistry, Medicine, Microbiology, Cell Biology, Genetics, Molecular Biology, Developmental Biology, Infectious Diseases, Space Science, Environmental Sciences not elsewhere classified, Biological Sciences not elsewhere classified, Chemical Sciences not elsewhere classified, Physical Sciences not elsewhere classified, resolution mass spectrometry, driven process optimization, critical process parameters, mechanistic studies revealed, >- acetic acid, lab batches suppressed, previously unreported impurity, dependent impurity escalation, scale process development, corresponding control strategies, 100 kg pilot, unknown impurity exhibited, 2 , control strategies, unknown impurity, thiophenecarboxylic acid

Dostupnost: https://doi.org/10.1021/acs.oprd.5c00104.s001
https://figshare.com/articles/journal_contribution/Overcoming_Scale-Dependent_Impurity_Escalation_in_Epalrestat_Synthesis_Identification_Mechanistic_Elucidation_and_Robust_Process_Control/29525194

Optofluidic Force Induction: A Workbench for Nanoparticle Characterization and Material Analytics

Autoři: Marko Šimić Christian Neuper Raphael Hauer a další

Témata: Medicine, Developmental Biology, Science Policy, Space Science, underlying physical principles, optofluidic force induction, online process analytics, critical process parameters, time nanoparticle characterization, nanoparticle characterization, results prove, recent achievements, prescribed regulations, precise knowledge, possible directions, particle sensitivity, ongoing developments, new avenues, mini review, many cases, industrially relevant, high throughput, final product, dispersion lies, directly affect, continuous production, complex samples, broad range

Relation: https://figshare.com/articles/journal_contribution/Optofluidic_Force_Induction_A_Workbench_for_Nanoparticle_Characterization_and_Material_Analytics/29120036

Dostupnost: https://doi.org/10.1021/acs.nanolett.5c01126.s004
https://figshare.com/articles/journal_contribution/Optofluidic_Force_Induction_A_Workbench_for_Nanoparticle_Characterization_and_Material_Analytics/29120036

Harnessing Raman spectroscopy for cell therapy bioprocessing

Autoři: Costa, Marta H.G. Carrondo, Inês Isidro, Inês A. a další

Přispěvatelé: Costa, Marta H.G. Carrondo, Inês Isidro, Inês A. a další

Témata: Bioprocess control, Bioreactors, Cell therapy manufacturing, Critical process parameters, Critical quality attributes, Process analytical technology, Biotechnology, Bioengineering, Applied Microbiology and Biotechnology

Popis souboru: application/pdf

Relation: 0734-9750; PURE: 110712510

Dostupnost: http://hdl.handle.net/10362/182889

Relatórios de estágio e Monografia Intitulada “Quality by design approach for twin screw wet granulation: a systematic review to identify critical process parameters and critical material attributes on granule properties”

Internship Reports and Monography entitled “Quality by design approach for twin screw wet granulation: a systematic review to identify critical process parameters and critical material attributes on granule properties'

Autoři: Novais, Joana Maria Fonseca

Témata: Twin Screw Wet Granulation, Quality by Design, Critical Material Atributes, Critical Quality Atributes, Critical Process Parameters

Dostupnost: https://hdl.handle.net/10316/112855

Realization of user-friendly bioanalytical tools to quantify and monitor critical components in bio-industrial processes through conceptual design

Autoři: Mandenius, Carl-Fredrik

Zdroj: Engineering in Life Sciences. 22(3-4):217-228

Témata: bioanalytics, conceptual design, critical process parameters, critical quality attributes, process analytical technology (PAT)

Popis souboru: electronic

Přístupová URL adresa: https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-181778
https://liu.diva-portal.org/smash/get/diva2:1619895/FULLTEXT01.pdf

Improving Market Access with a Lean Approach to Quality

Autoři: Bigirwa, Bri'an Ekeocha, Zita Byrn, Stephen a další

Zdroj: The Proceedings of the BIRS Community. 1

Témata: survivability, efficiency, thermal tolerant, critical process parameters, Newcastle disease strain I-2, vaccine production

Popis souboru: application/pdf

Extraction process in Chuantieling (CTL) based on the quality by design (QbD) concept

Autoři: Li Ya Li Zirui Guo Zhihua

Zdroj: Digital Chinese Medicine, Vol 5, Iss 2, Pp 189-198 (2022)

Témata: Box-Behnken design (BBD), 0301 basic medicine, Critical quality attributes (CQAs), 0303 health sciences, Quality by design (QbD), 6. Clean water, Critical process parameters (CPPs), Other systems of medicine, 03 medical and health sciences, Chuantieling (CTL), Medicine, Mahuang (Ephedrae Herba), RZ201-999

Přístupová URL adresa: https://doaj.org/article/433d87cabdb5451fb1971a5fce8f4e68

Identification of critical process parameters for expansion of clinical grade human Wharton's jelly‐derived mesenchymal stromal cells in stirred‐tank bioreactors

Autoři: Alba López‐Fernández Víctor Garcia‐Gragera Martí Lecina a další

Přispěvatelé: Alba López‐Fernández Víctor Garcia‐Gragera Martí Lecina a další

Zdroj: DAU Arxiu Digital de la Universitat Ramon Llull
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Témata: GMP-compliant scale-up, 0301 basic medicine, 0303 health sciences, Cell Culture Techniques, Mesenchymal Stem Cells, Cell Differentiation, Culture Media, Serum-Free, Umbilical Cord, microcarriers, 03 medical and health sciences, Bioreactors, critical process parameters, Humans, Wharton Jelly, human Wharton's jelly-derived mesenchy-mal stromal cells, xeno- and serum-free media, Cells, Cultured, stirred-tank bioreactors, Cell Proliferation

Popis souboru: application/pdf

Přístupová URL adresa: https://pubmed.ncbi.nlm.nih.gov/38403461

PROCESS VALIDATION FOR SELECTED SOLID DOSAGE FORM AS PER FDA GUIDELINES

Autoři: Rajender Singh

Témata: Oral solid dosage form, Paracetamol, Process validation, Validation, critical process parameters, US-FDA

Design of experiments and design space approaches in the pharmaceutical bioprocess optimization

Autoři: Kasemiire, Alice Avohou, Tonakpon Hermane De Bleye, Charlotte a další

Přispěvatelé: Kasemiire, Alice Avohou, Tonakpon Hermane De Bleye, Charlotte a další

Zdroj: European Journal of Pharmaceutics and Biopharmaceutics. 166:144-154

Témata: 0301 basic medicine, 0303 health sciences, Design of Experiments, Chemistry, Pharmaceutical, Pharmacie, pharmacologie & toxicologie, Sciences de la santé humaine, Quality Improvement, Biopharmaceutics, Critical process parameters, 03 medical and health sciences, Drug Development, Research Design, Drug Discovery, Critical quality attributes, Humans, Quality by Design, Human health sciences, Design Space, Pharmacy, pharmacology & toxicology

Přístupová URL adresa: https://pubmed.ncbi.nlm.nih.gov/34147574
https://europepmc.org/article/MED/34147574
https://orbi.uliege.be/handle/2268/261140
https://www.sciencedirect.com/science/article/pii/S0939641121001715

Quality by design (QbD) concept review in pharmaceuticals

Autoři: Jagtap, Kaustubh Chaudhari, Bharati Redasani, Vivekkumar

Zdroj: 15(4):303-307