Results 51 to 60 of about 62,558,702 (211)

Analysis and critical review of ICH Q8, Q9 and Q10 from a generic pharmaceutical industry view point [PDF]

Makedonsko Farmacevtski Bilten, 2012
Generic industry aims to produce safe, efficient, built-in quality medicines that will satisfy patients’ requirements and will be competitive on the market.
Ljuba Karanakov, Jasmina Tonic-Ribarska, Marija Glavas-Dodov, Suzana Trajkovic-Jolevska   +3 more
doaj  

Formulation and optimization of ivermectin nanocrystals for enhanced topical delivery

International Journal of Pharmaceutics: X, 2023
The increasing resistance to antiparasitic drugs and limited availability of new agents highlight the need to improve the efficacy of existing treatments.
Hoda Awad, Mutasem Rawas-Qalaji, Rania El Hosary, Jayalakshmi Jagal, Iman Saad Ahmed   +4 more
doaj   +1 more source

Process Analytical Technology (PAT) for Continuous Purification of mRNA via Precipitation and Tangential Flow Filtration

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Continuous downstream processing of messenger ribonucleic acid (mRNA) therapeutics requires purification strategies that are scalable, robust, and capable of removing product‐ and process‐related impurities from in vitro transcription mixtures.
Rajan R. Bhawnani, Maria del Carme Pons Royo, Rohan Kadambi, Andrew Hatas, Steve Burcat, Tyler Arnold, Hasan Al‐Mahayni, Richard D. Braatz, Allan S. Myerson   +8 more
wiley   +1 more source

Design Space and QbD Approach for Production of Drug Nanocrystals by Wet Media Milling Techniques

Pharmaceutics, 2018
Drug nanocrystals are nanosized solid drug particles, the most important application of which is the improvement of solubility properties of poorly soluble drug materials.
Leena Peltonen
doaj   +1 more source

Bridging the translational gap in clinical nanomedicine: From rational design to clinical reality

BMEMat, EarlyView.
Nanotechnology offers a multi‐faceted approach to modern healthcare, encompassing high‐sensitivity diagnostic imaging, innovative vaccine delivery, and targeted therapeutics. This review explores how these nanomedicine applications address critical challenges in cancer recurrence and the treatment of neurologic and respiratory diseases to combat rising
Ahmed H. Ghonaim, Marwa Ahmed El‐Naka, Wedad M. Nageeb, Atta Ullah Khan, Noura M. Seleem, Aliaa Abdelghafar, Doaa Zamel, Yang Liu, Qigai He, Wentao Li   +9 more
wiley   +1 more source

Examining the basic principles of quality by design (QbD) approach in analytical studies

, 2021
Although the first application of Quality by Design (QbD) concept started for product development studies, the number of studies regarding its application to analytical development has been increased recently.
Özsoy, Yıldız, ERGİNER, Yıldız, Aksu, Buket, MESUT, Burcu, Onal, Cem   +4 more
core   +1 more source

A Review on Quality by Design Approach in Analytical Methods [PDF]

, 2022
Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives for a product, process understanding, and process control based on knowledge and quality risk management.
Katekar, Vinayak, Ingle, Priyanka, Dhage, Shivprasad, Sangule, Dipali, Jadhav, Krushna, Bhurbhure, Om   +5 more
core   +1 more source

Desarrollo de una metodología basada en la gestión del conocimiento para la apropiación de la filosofía QUALITY BY DESIGN (QBD) en empresas del sector cosmético colombiano [PDF]

, 2017
Se presenta una propuesta metodológica para implementar la filosofía Quality by Design (Calidad desde el diseño) en empresas del sector cosmético colombiano, tomando como elemento orientador los principios de la Gestión del Conocimiento.
García Aponte, Oscar Fabián
core  

Status and future of recombinant adeno‐associated virus vector manufacturing

Biotechnology Progress, EarlyView.
Abstract Sixty years of adeno‐associated virus (AAV) research illustrates a trajectory marked by basic science exploration, iterative innovation, persistent challenges, a number of clinical setbacks, as well as commercial therapeutic triumphs. This continual evolution has led to recombinant AAV (rAAV) becoming a cornerstone of modern gene therapy ...
Frank Agbogbo, David Dismuke
wiley   +1 more source

Modeling-based Approach Towards Quality by Design for a Telescoped Process

CHIMIA
A telescoped, two-step synthesis was investigated by applying Quality by Design principles. A kinetic model consisting of 12 individual reactions was successfully established to describe the synthesis and side reactions.
This Zahnd, Maja Kandziora, Michael K. Levis, Andreas Zogg   +3 more
doaj   +1 more source