Results 41 to 50 of about 6,391 (215)

An industrial case study: QbD to accelerate time-to-market of a drug product

AAPS Open, 2021
The use of a Quality by Design (QbD) approach in the development of pharmaceutical products is known to bring many advantages to the table, such as increased product and process knowledge, robust manufacturing processes, and regulatory flexibility ...
Madalena Testas, Tiago da Cunha Sais, Leonardo Piccoli Medinilha, Katia Nami Ito Niwa, Lucas Sponton de Carvalho, Silvia Duarte Maia, Anderson Flores, Lígia Pedroso Braz, José Cardoso Menezes, Cássio Yooiti Yamakawa   +9 more
doaj   +1 more source

QbD-driven development and validation of HPLC method for determination of Bisphenol A and Bis-sulphone in environmental samples

, 2019
A large number of hazardous chemicals have entered the environment due to the rapid growth of urbanisation and industrial development and are exerting harmful effects on wildlife as well as on human health.
K V Krishna (6834269), Garima Kachhawa (6834281), Sunil Kumar Dubey (4728093), Rajesh Khadgawat (6834278), Gautam Singhvi (6834284), Rajeev Taliyan (6834275), Rajesh Pradhan (536401), Geetika Wadhwa (6834272)   +7 more
core   +1 more source

Analysis of generalized QBD queues with matrix-geometrically distributed batch arrivals and services [PDF]

, 2016
In a quasi-birth–death (QBD) queue, the level forward and level backward transitions of a QBD-type Markov chain are interpreted as customer arrivals and services.
Horváth, Gábor
core   +1 more source

Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing

Journal of Chemistry, 2015
Pharmaceutical industry has been emerging rapidly for the last decade by focusing on product Quality, Safety, and Efficacy. Pharmaceutical firms increased the number of product development by using scientific tools such as QbD (Quality by Design) and PAT
N. V. V. S. S. Raman, Useni Reddy Mallu, Hanimi Reddy Bapatu   +2 more
doaj   +1 more source

QbD enabled Process Variable Study to Develop Sustained Release Chitosan-Alginate Embedded Delivery System for Improved Patient Compliance

Brazilian Journal of Pharmaceutical Sciences, 2022
The current investigation entail systematic Quality by Design (QbD)-enabled approach for the development of Sustained released embedded drug delivery systems of L-Arginine employing ionic gelation technique to attain improved patient compliance.
Vijay Sharma, Lalit Singh, Navneet Verma
doaj   +1 more source

Expanding Quality by Design Principles to Support 3D Printed Medical Device Development Following the Renewed Regulatory Framework in Europe

Biomedicines, 2022
The vast scope of 3D printing has ignited the production of tailored medical device (MD) development and catalyzed a paradigm shift in the health-care industry, particularly following the COVID pandemic.
Livia Adalbert, S P Yamini Kanti, Orsolya Jójárt-Laczkovich, Hussein Akel, Ildikó Csóka   +4 more
doaj   +1 more source

Beyond Biomimetics: Pathology‐Informed Engineering Rescues Reconstituted HDL From Inflammatory Dysfunction for Sepsis Immunotherapy

Advanced Science, EarlyView.
A pathology‐informed engineering strategy rescues reconstituted HDL from inflammatory dysfunction in sepsis. By integrating a ceria nanozyme‐celastrol coordination complex, the platform preserves HDL structure and endotoxin handling, sustains hierarchical intracellular delivery, and enhances immunoregulation across pathological models, translating ...
Han Zhou, Lei Zhang, Xingyu Cai, Jiajia Su, Guangyu Dai, Xue Chen, Hanming Wang, Jia Hua, Jianping Liu, Chunmeng Sun, Xiancheng Chen, Erhao Wang, Wenli Zhang   +12 more
wiley   +1 more source

QbD-Driven Analytical Method Development and Validation for Raloxifene Hydrochloride in Pure Drug and Solid Oral Dosage Form

, 2019
The present research work encompasses systematic development of a simple, fast, sensi- tive, reproducible and cost-effective reversed-phase high-performance liquid chromatographic (RP-HPLC) method, applying the principles of Quality by design (QbD) for ...
Bhupinder Singh (443885), Rajneet Kaur Khurana (7468400), Gajanand Sharma (3610616), Teenu Sharma (6859964), Om Prakash Katare (7468403), Atul Jain (827616)   +5 more
core   +1 more source

Critical Quality Attributes of Lipid Nanoparticles for mRNA: Selection, Justification, and Control

Регуляторные исследования и экспертиза лекарственных средств
INTRODUCTION. Lipid nanoparticles represent a promising platform for targeted drug delivery, including nucleic acids, as demonstrated by COVID-19 vaccines. Unlike conventional dosage forms, lipid nanoparticles are complex supramolecular systems where the
U. A. Efremova, I. I. Terninko
doaj   +1 more source

Developing Highly Effective Nanoparticle mRNA Therapeutic for Pediatric Acute Respiratory Distress Syndrome

Advanced Science, EarlyView.
Sepsis‑induced pediatric acute respiratory distress syndrome suppresses FOXF1 in lung endothelial cells which causes life‐threatening lung damage. To counter this, researchers developed nanoparticles that specifically target these cells and deliver FOXF1 mRNA.
Zicheng Deng, Wen Gao, Jonathan Do, Danli Lu, Ying‐Wei Lan, Andreas Damianos, Gautam Verma, Ali Al Siraj, Isabella Lowry, Lance Peter, Nicholas E. Banovich, Fei Sun, Hua He, Tanya V. Kalin, Vladimir V. Kalinichenko   +14 more
wiley   +1 more source