Results 71 to 80 of about 741 (144)

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

Регуляторные исследования и экспертиза лекарственных средств
INTRODUCTION. Quality by design (QbD) is a systematic approach to pharmaceu­tical development that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management.
M. V. Karlina, V. M. Kosman, M. N. Makarova, V. G. Makarov   +3 more
doaj   +1 more source

Development of a Resveratrol Nanosuspension Using the Antisolvent Precipitation Method without Solvent Removal, Based on a Quality by Design (QbD) Approach

, 2019
The purpose of this study was to develop a resveratrol nanosuspension with enhanced oral bioavailability, based on an understanding of the formulation and process parameters of nanosuspensions and using a quality by design (QbD) approach.
Eun-Sol Ha, In-hwan Baek, Du Hyung Choi, Jeong-Soo Kim, Dong-Hyun Ha, Do-Hoon Kuk, Ji-Su Jeong, Min-Soo Kim, Woo-Yong Sim, Seon-Kwang Lee, Heejun Park, Sung-Joo Hwang, Seong Hoon Jeong, Jin-Wook Yoo   +13 more
core   +1 more source

Фармацевтична розробка протиепілептичних таблеток на основі субстанції леветирацетам. специфіка проведення фармако-технологічних досліджень при стандартизації лікарського засобу [PDF]

, 2017
Remedies containing Levetiracetam are widely used in medical practice for treatment of different forms of epilepsy. In result of pharmaceutical development, manufacturing formulation for the tablets on the basis of Levetiracetam substance was obtained ...
Asmolova, Natalia, Eugene Shakin, Shakin, Eugene, Tatyana Yarnykh, Natalia Asmolova, Yarnykh, Tatyana   +5 more
core   +1 more source

Hipertansiyon Tedavisinde Etkili Sabit Dozlu Kombinasyon Tasarımı Ve Değerlendirilmesi

, 2018
Bu çalışmanın amacı, hipertansiyon tedavisinde farklı mekanizmalar ile etki gösteren amlodipin ve enalapril etkin maddelerini tablet dozaj şekli halinde içeren Sabit Dozlu Kombinasyon un (SDK) Kalite Tasarımı (QbD) prensiplerine göre geliştirilmesidir.
Diren Sarısaltık Yaşın
core   +1 more source

Formulation Optimization of Felodipine Push–Pull Osmotic Pump Capsules Using Quality by Design Approach

Scientia Pharmaceutica
Recently, the Quality by Design (QbD) principle has been implemented in the pharmaceutical industry to enhance product and process understanding through a science- and risk-based approach.
Chaowalit Monton, Poj Kulvanich
doaj   +1 more source

QbD Approach-Based Preparation and Optimization of Hydrophobic Ion-Pairing Complex of Lysozyme with Sodium Dodecyl Sulphate to Enhance Stability in Lipid-Based Carriers

Pharmaceutics
Hydrophobic ion pairing (HIP) complexation was found to be an efficient approach in modulating the release and enhancing the stability and encapsulation of hydrophilic macromolecules such as proteins in hydrophobic nano/microcarriers.
Alharith A. A. Hassan, Tamás Sovány, Krisztián Pamlényi, Martin Deák, Viktória Hornok, Edit Csapó, Géza Regdon, Ildikó Csóka, Katalin Kristó   +8 more
doaj   +1 more source

A Review on Quality by Design Approach (QBD) for Pharmaceuticals

, 2019
Quality by Design is the modern approach for quality of pharmaceuticals. It describes use of Quality by Design to ensure quality of Pharmaceuticals. In this review, the Quality by Design is described and some of its elements identified.
Bhise, Jayashri J., Jadhav, Pallavi U., Bhusnure, Omprakash G., Gholve, Sachin B., Mujewar, Imran N., Mule, Shrikrishna T.   +5 more
core   +1 more source

Operationalizing halal assurance within the quality-by-design pharmaceutical development lifecycle: A conceptual framework for biopharmaceutical development

   development. However, existing halal assurance and regulatory frameworks remain largely focused on organizational governance, material compliance, certification, traceability, and risk management, without explicitly operationalizing halal ...
Nurhusna Samsudin, Mohammad Aizat Jamaludin, Yumi Zuhanis Has-Yun Hashim, Mohd Hafidz Mahamad Maifiah, Phirdaous Bin Abbas   +4 more
core   +1 more source

ISEV2025 Abstract Book

Journal of Extracellular Vesicles, Volume 14, Issue S1, October 2025.
wiley   +1 more source

Engineering of budesonide-loaded lipid-polymer hybrid nanoparticles using a quality-by-design approach

, 2018
Chronic obstructive pulmonary disease (COPD) is a complex disease, characterized by persistent airflow limitation and chronic inflammation. The purpose of this study was to design lipid-polymer hybrid nanoparticles loaded with the corticosteroid ...
Leng, Donglei, Thanki, Kaushik, Yang, Mingshi, Camilla Foged, Elias Fattal, Foged, Camilla, Fattal, Elias, Donglei Leng, Kaushik Thanki, Mingshi Yang   +9 more
core   +1 more source