Suchergebnisse - "quality by design"

A Practical Approach to Implementing ICH Q14: Tools for Analytical Quality by Design in Capillary Electrophoresis Method Development

Autoren: Tricht, Ewoud van Sänger-van de Griend, Cari, Dr

Quelle: Electrophoresis. 46(13-14):933-953

Schlagwörter: analytical quality by design (AQbD), International Council for Harmonization (ICH) Q2(R2), International Council for Harmonization (ICH) Q14, method lifecycle management

Dateibeschreibung: electronic

Zugangs-URL: https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-561931
https://doi.org/10.1002/elps.8110

Pharmaceutical Quality by Design Approach to Develop High-Performance Nanoparticles for Magnetic Hyperthermia

Autoren: Ansari, Shaquib Rahman Suárez-López, Yael del Carmen Thersleff, Thomas et al.

Quelle: ACS Nano. 18(23):15284-15302

Schlagwörter: quality by design, superparamagnetic nanoparticles, magnetic hyperthermia, design of experiments, flame spray pyrolysis, doped ferrites

Dateibeschreibung: print

Zugangs-URL: https://urn.kb.se/resolve?urn=urn:nbn:se:su:diva-232520
https://doi.org/10.1021/acsnano.4c04685

Investigation of potential efficacy of nanospanlastic vesicular drug delivery system for targeting the brain: formulation, characterization, and in-vivo studies

Autoren: Patel, Ashwini Pandey, Prachi

Quelle: Journal of Applied Pharmaceutical Research; Vol. 13 No. 4 (2025); 132-142

Schlagwörter: quality by design, nasal formulation, brain targeting, Edaravone, nanospanlastics

Dateibeschreibung: application/pdf

Zugangs-URL: https://www.japtronline.com/index.php/joapr/article/view/1340

A QbD-based stability-indicating RP-HPLC method for larotrectinib: degradation kinetics and integrated white, green, and blue analytical assessment

Autoren: P. N. S, Syamala Adikay, Sreedevi

Quelle: Journal of Applied Pharmaceutical Research; Vol. 13 No. 4 (2025); 143-161

Schlagwörter: RP HPLC, Greenness, Whiteness, Forced Degradation, Quality by Design, Larotrectinib

Dateibeschreibung: application/pdf

Zugangs-URL: https://www.japtronline.com/index.php/joapr/article/view/1436

Quality by design-assisted green uv-spectrophotometric method development and validation for the quantitative estimation of letrozole

Autoren: Shahrikh S. Pakali Mahesh Palled Shailendra S. Suryawanshi

Quelle: Drug Analytical Research, Vol 9, Iss 1 (2025)
Drug Analytical Research; Vol. 9 No. 1 (2025); 32-41
Drug Analytical Research; v. 9 n. 1 (2025); 32-41

Schlagwörter: UV-Spectrophotometry, Chemistry, Letrozole, Quality by Design, Design of Experiment, QD1-999, TP248.13-248.65, Green Analytical Chemistry, Biotechnology

Dateibeschreibung: application/pdf

Zugangs-URL: https://doaj.org/article/a2da7293004648b69d6417c71fcc846d
https://seer.ufrgs.br/index.php/dar/article/view/147251

Quality by design driven RP-HPLC method optimization for analysis of levothyroxine and liothyronine in bulk and tablet dosage form

Autoren: Darade, Ramdas Pekamwar, Sanjay

Quelle: Journal of Applied Pharmaceutical Research, Vol 13, Iss 2, Pp 139-148 (2025)
Journal of Applied Pharmaceutical Research; Vol. 13 No. 2 (2025); 139-148

Schlagwörter: RP HPLC, quality by design, levothyroxine, Levothyroxine, Method Development, RM1-950, Liothyronine, RS1-441, Pharmacy and materia medica, rp hplc, Quality by Design, method development, Therapeutics. Pharmacology, liothyronine

Dateibeschreibung: application/pdf

Zugangs-URL: https://doaj.org/article/f39e7a41511841899959272c88b9a493
https://www.japtronline.com/index.php/joapr/article/view/867

OPTIMIZATION OF A SURFACEENHANCED RAMAN CHEMICAL IMAGING METHOD FOR PHARMACEUTICAL ACTIVE INGREDIENT TRACKING IN THE CONTEXT OF IN-VITRO SKIN EQUIVALENT-MODEL PERMEATION STUDIES

Autoren: Kemik, Kevser De Bleye, Charlotte Sacre, Pierre-Yves et al.

Quelle: 22nd Forum of Pharmaceutical Sciences, La Roche-en-Ardenne, Belgium [BE], 31 mars au 1er avril 2025

Schlagwörter: SER-CI, permeation studies, imaging, nicotine, Episkin, silver nanoparticles, AgNPs, Quality by Design, QbD, Optimization plan, DoE, Human health sciences, Pharmacy, pharmacology & toxicology, Sciences de la santé humaine, Pharmacie, pharmacologie & toxicologie

Zugangs-URL: https://orbi.uliege.be/handle/2268/330268

Implementation of the quality-by-design concept for an adeno-associated viral vector-based gene therapy

Autoren: D. S. Kopein G. N. Poroshin R. A. Khamitov

Quelle: Биопрепараты: Профилактика, диагностика, лечение, Vol 25, Iss 2, Pp 141-155 (2025)

Schlagwörter: atmp, critical quality attribute, quality by design, aav production technology, aav, adeno-associated virus, qtpp, gene therapy, risk-based approach, qbd, cqa, quality target product profile, adenoassociated viral vector, dmd, Medicine, advanced therapy medicinal product, duchenne muscular dystrophy, TP248.13-248.65, Biotechnology

Zugangs-URL: https://doaj.org/article/028c4b0dbc144312ab0b9af28a56df39

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

Autoren: M. V. Karlina V. M. Kosman M. N. Makarova et al.

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

Schlagwörter: 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

Zugangs-URL: https://doaj.org/article/65c3e1696d494654a8e4410181eaa6a4

Designing a sustained-release solid oral formulation for overactive bladder treatment: a quality by design approach

Autoren: Sharma, Neeraj Bhatia, Daksh Shambhakar, Sharda et al.

Quelle: Journal of Applied Pharmaceutical Research, Vol 13, Iss 1, Pp 123-135 (2025)
Journal of Applied Pharmaceutical Research; Vol. 13 No. 1 (2025); 123-135

Schlagwörter: Mirabegron, quality by design, oral drug delivery, Overactive bladder, RM1-950, Sustained release tablet, mirabegron, RS1-441, Pharmacy and materia medica, Oral Drug delivery, overactive bladder, Quality by Design, Polyethylene oxide, Therapeutics. Pharmacology, sustained release tablet, polyethylene oxide

Dateibeschreibung: application/pdf

Zugangs-URL: https://doaj.org/article/4938117659824234ab35e77f440aed2c
https://www.japtronline.com/index.php/joapr/article/view/820

Application of quality by design and near infrared spectroscopy in manufacturing and control of freeze-dried drug products

Autoren: Clua Palau, Glòria

Weitere Verfasser: University/Department: Universitat Autònoma de Barcelona. Departament de Química

Thesis Advisors: Maspoch Andrés, Santiago

Quelle: TDX (Tesis Doctorals en Xarxa)

Schlagwörter: Qualitat per disseny, Calidad por diseño, Quality by design, Liofilització, Liofilización, Freeze-drying, Espectròscopia NIR, Espectroscopia NIR, Near Intrared Spectroscopy, Ciències Experimentals

Dateibeschreibung: application/pdf

Zugangs-URL: http://hdl.handle.net/10803/663954

INNOVATIVE APPROACHES TO THE VALIDATION OF ANALYTICAL METHODS IN PHARMACEUTICAL MANUFACTURING

Quelle: Science-based technologies; Vol. 67 No. 3 (2025); 419-428
Наукоемкие технологии; Том 67 № 3 (2025); 419-428
Наукоємні технології; Том 67 № 3 (2025); 419-428

Schlagwörter: validation, analytical methods, DoE, pharmaceutical production, RSM, фармацевтичне виробництво, якість, Quality by Design, CMA, валідація, аналітичні методики, PAT, CPP

Dateibeschreibung: application/pdf

Zugangs-URL: https://jrnl.nau.edu.ua/index.php/SBT/article/view/19951

A Comprehensive Review of Current Trends and Regulatory Frameworks in Generic Drug Development

Autoren: Chinna Reddy Palem1*, Ravindar Rendla, Nishanth Kumar Nagamalli1, Vamshi Krishna Lekkala2, Sridhar Gumudevelli2

Schlagwörter: Generic drug development, Quality by Design, Process Analytical Technology, Regulatory framework

Quality by design optimization of microemulsions for topical delivery of Passiflora setacea seed oil

Autoren: Daniel T. Pereira Douglas Dourado Danielle T. Freire et al.

Quelle: Beilstein Journal of Nanotechnology, Vol 16, Iss 1, Pp 2116-2131 (2025)

Schlagwörter: design of experiments (doe), microemulsions, nanotechnology, natural products, passion fruit, quality by design, skin delivery, Technology, Chemical technology, TP1-1185, Science, Physics, QC1-999

Dateibeschreibung: electronic resource

Relation: https://doaj.org/toc/2190-4286

Zugangs-URL: https://doaj.org/article/641bbbab2ce3419b94b2dad8ce91025a

Development and validation of a robust QbD-guided (RP-HPLC) analytical technique for quantifying coenzyme Q10 in pharmaceutical dosage form

Autoren: Vishal Kumar Pathak Phool Chandra Bhupendra Singh

Quelle: Journal of Applied Pharmaceutical Research, Vol 13, Iss 5, Pp 271-286 (2025)

Schlagwörter: coenzyme q10, rp-hplc, quality by design (ccd), method validation, Pharmacy and materia medica, RS1-441, Therapeutics. Pharmacology, RM1-950

Dateibeschreibung: electronic resource

Relation: https://japtronline.com/index.php/joapr/article/view/1696; https://doaj.org/toc/2348-0335

Zugangs-URL: https://doaj.org/article/74755a1e1226453ebc150d3c2cd13537

QbD-guided HPTLC method development and validation for quantitative estimation of anticancer drugs

Autoren: Bhavik Jani Hitesh Vekariya

Quelle: Journal of Applied Pharmaceutical Research, Vol 13, Iss 5, Pp 190-202 (2025)

Schlagwörter: hptlc, anticancer drug, method validation, quality by design, factorial design, Pharmacy and materia medica, RS1-441, Therapeutics. Pharmacology, RM1-950

Dateibeschreibung: electronic resource

Relation: https://japtronline.com/index.php/joapr/article/view/1465; https://doaj.org/toc/2348-0335

Zugangs-URL: https://doaj.org/article/83c160fb4833476188bd198d09e2b8d4

QbD-driven RP-HPLC method for the simultaneous analysis of dihydropyridines calcium channel blockers in pharmaceuticals

Autoren: Mariana Horyn Marjan Piponski Liubomyr Kryskiw et al.

Quelle: BMC Chemistry, Vol 19, Iss 1, Pp 1-16 (2025)

Schlagwörter: Calcium channel blockers, Quality by design, HPLC, Assay, Green chemistry, Chemistry, QD1-999

Dateibeschreibung: electronic resource

Relation: https://doaj.org/toc/2661-801X

Zugangs-URL: https://doaj.org/article/e7b973980f0a49458604e591944479ac

Enhanced Quality by Design (QbD) Approach to the Development of an Oral Extended Release Formulation

Nova Abordagem de Quality by Design (QbD) para uma Formulação Oral de Libertação Prolongada

Autoren: Sousa, Ana Sofia Pereira de

Schlagwörter: Análise Multivariada, Design of experiments, Libertação prolongada, Machine Learning, Quality by design, Extended release, Multivariate data analysis, Ciências médicas e da saúde::Ciências da saúde

Verfügbarkeit: https://hdl.handle.net/10316/121115

Towards the Scalable Manufacturing of Liposomal Drug Products - A Quality by Design Approach

Desenvolvimento de Processos de Fabrico Escaláveis para a Produção de Produtos Farmacêuticos Lipossómicos - Uma Abordagem “Quality by Design'

Autoren: Caleiras, Mariana Biscaia

Schlagwörter: Liposomes, Quality-by-design, Process Time Efficiency, Membrane Fluidity, Industrial Continuous Manufacturing, Lipossomas, Eficiência Temporal do Processo, Fluidez da Membrana, Fabrico Industrial Contínuo, Ciências médicas e da saúde::Ciências da saúde

Verfügbarkeit: https://hdl.handle.net/10316/120460

Method Development Based on an Analytical Quality by Design (AQBD) Approach

Desenvolvimento de Métodos Analíticos com Base na Abordagem Quality by Design (AQBD)

Autoren: Chiarentin, Lucas

Schlagwörter: Atributos críticos analíticos (CAAs), Desenvolvimento do método analítico, Perfil analítico alvo (ATP), Quality by design analítico, Variáveis críticas do método (CMVs), Analytical method development, Analytical quality by design, Analytical target profile (ATP), Critical analytical attributes (CAAs), Critical method variables (CMVs), Ciências médicas e da saúde::Ciências da saúde

Verfügbarkeit: https://hdl.handle.net/10316/119529