Results 71 to 80 of about 63,340,489 (278)

Development and Validation of an in-line API Quantification Method Using AQbD Principles Based on UV-Vis Spectroscopy to Monitor and Optimise Continuous Hot Melt Extrusion Process

Pharmaceutics, 2020
A key principle of developing a new medicine is that quality should be built in, with a thorough understanding of the product and the manufacturing process supported by appropriate process controls. Quality by design principles that have been established
Juan Almeida, Mariana Bezerra, Daniel Markl, Andreas Berghaus, Phil Borman, Walkiria Schlindwein   +5 more
doaj   +1 more source

Safety of Daprodustat for the Treatment of Chronic Kidney Disease Anemia: Final Analysis of a Multicenter Postmarketing Surveillance Study in Japan

Therapeutic Apheresis and Dialysis, EarlyView.
ABSTRACT Introduction This final analysis of a multicenter, prospective postmarketing surveillance study evaluated the safety of daprodustat in patients with chronic kidney disease anemia in routine clinical practice in Japan. Methods Patients who initiated daprodustat between September 2020 and July 2022 were registered.
Tadao Akizawa, Kyomi Kanaya, Kiyomi Aizawa, Masanori Onoki, Hirofumi Ozeki, Kazuko Suzuki, Ai Hayashi, Tomohiko Asamura   +7 more
wiley   +1 more source

A Quality by Design alkalmazása a gyógyszerkészítmények fejlesztése során

, 2016
A diplomamunka a gyógyszerek fejlesztésének, és gyártásának új modelljével, a Quality by Design-al foglalkozik. Bemutatja a még jelenleg alkalmazott QbT modellt, és összehasonlítja ezzel az új modellel. Részletesen ismerteti a QbD elemeit, és előnyeit. A
Biró, Lajos
core  

Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD)

Brazilian Journal of Pharmaceutical Sciences, 2018
According to Quality by Design (QbD) concept, quality should be built into product/method during pharmaceutical/analytical development. Usually, there are many input factors that may affect quality of product and methods. Recently, Design of Experiments (
Isa Martins Fukuda, Camila Francini Fidelis Pinto, Camila dos Santos Moreira, Alessandro Morais Saviano, Felipe Rebello Lourenço   +4 more
doaj   +1 more source

Forecasting the Dialysis Burden in Japan: Validation‐Based Projections of Prevalence and Incidence Through 2050

Therapeutic Apheresis and Dialysis, EarlyView.
ABSTRACT Background Japan has one of the highest dialysis prevalence rates worldwide and a shrinking, aging population. Whether dialysis burden has entered a sustained post‐peak phase or whether recent declines partly reflect pandemic‐related disruptions remains uncertain.
Hatice Şahin, Berrak Itır Aylı, Nüket Paksoy   +2 more
wiley   +1 more source

Association Between Individualized Education for Kidney Replacement Therapy Modality Selection and Peritoneal Dialysis Initiation: A Cross‐Sectional Study

Therapeutic Apheresis and Dialysis, EarlyView.
ABSTRACT Introduction Peritoneal dialysis (PD) is an established home‐based kidney replacement therapy (KRT), but its uptake remains low in Japan. We evaluated whether individualized education in a dedicated outpatient clinic was associated with the initiation of PD.
Yasuko Ito, Ryuichi Yoshimura, Takaki Yamauchi, Yuta Funakoshi, Hirotaka Sonoda, Seiji Kobayashi, Hiroyuki Terawaki, Takafumi Ito   +7 more
wiley   +1 more source

Development and validation of a robust RP-HPLC method for Landiolol using analytical quality by design

Discover Chemistry
A systematic Analytical Quality by Design based reverse-phase high-performance liquid chromatography method was successfully developed and validated for the quantification of Landiolol in pharmaceutical formulations.
S. Harshini, Panneerselvam Theivendren, Saravanan Govindaraj   +2 more
doaj   +1 more source

Analytical Quality by Design approach in the development of a green reversed-phase ultra-high performance liquid chromatography/high-resolution time-of-flight mass spectrometry method for the simultaneous analysis of synthetic antimicrobial and hypotensive peptides

Journal of Chromatography Open
The growing therapeutic interest in peptides from Tityus stigmurus scorpion venom and their analogues highlights the need for the development of robust analytical methods for these compounds.
Ana Roberta Pereira Johnson dos Anjos, Márcia Natália da Silveira Pinto, Dayanne Lopes Porto, Fabio Santos de Souza, Rui Oliveira Macedo, Matheus de Freitas Fernandes Pedrosa, Cícero Flávio Soares Aragão   +6 more
doaj   +1 more source

Organoids in pediatric cancer research

FEBS Letters, EarlyView.
Organoid technology has revolutionized cancer research, yet its application in pediatric oncology remains limited. Recent advances have enabled the development of pediatric tumor organoids, offering new insights into disease biology, treatment response, and interactions with the tumor microenvironment.
Carla Ríos Arceo, Jarno Drost
wiley   +1 more source

Reliability Estimation by ALT when no Analytical Model Holds [PDF]

, 2010
This paper presents an accelerated life testing method applicable to devices or systems when no analytical relationship with respect to the stress level can be defined.
R. Hambli, HAMBLIA, Ridha, GUERIN, Fabrice, P. Lantieri, LANTIERI, Pascal, F. Guérin   +5 more
core   +1 more source