Results 31 to 40 of about 2,590,147 (263)

Determination of Bupropion and Its Impurities via a Chaotropic Chromatography Method Following Analytical Quality-by-Design Principles for Method Development

Pharmaceuticals, 2022
A novel chaotropic chromatography method for the quantitative determination of bupropion and its impurities, following analytical quality-by-design (AQbD) principles, is presented.
Kostas Gkountanas, Anđelija Malenović, Yannis Dotsikas   +2 more
doaj   +1 more source

Quality-by-Design: Are We There Yet? [PDF]

AAPS PharmSciTech, 2013
In 2012, the Quality-by-Design and Product Performance Focus Group of AAPS conducted a survey to assess the state of adoption and perception of Quality-by-Design (QbD). Responses from 149 anonymous individuals from industry-including consultants-(88%), academia (7%), and regulatory body (4%), were collected.
Jack, Cook, Maria T, Cruañes, Manish, Gupta, Steve, Riley, John, Crison   +4 more
openaire   +2 more sources

Understanding Pharmaceutical Quality by Design [PDF]

The AAPS Journal, 2014
This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. QbD elements include the following: (1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product; (2) product design and understanding including identification of critical material ...
Amidon, Gregory, Polli, James, Woodcock, Janet, Yu, Lawrence X., Khan, Mansoor A., Hoag, Stephen W., Raju, Gokaraju K   +6 more
openaire   +4 more sources

Implementing greening into design in analytical chemistry

Talanta Open, 2022
From the pharmaceutical industry is known the approach Quality-by-Design (QbD) and this has great influence on analytical methods and procedures it employs.
Jelena Jurjeva, Mihkel Koel
doaj   +1 more source

Identification of critical process parameters and quality attributes for bioreactor-based expansion of human MSCs

Frontiers in Bioengineering and Biotechnology
Mesenchymal stem/stromal cells (MSCs) have been identified as a promising therapeutic option for osteoarthritis, graft vs. host disease and cardiovascular diseases, among others.
Laura Herbst, Bastian Nießing, Robert H. Schmitt, Robert H. Schmitt   +3 more
doaj   +1 more source

HPLC method development for fampridine using Analytical Quality by Design approach

Acta Pharmaceutica, 2020
Offering a systematic and multivariate analysis of the analytical procedure, development and validation of HPLC methods using Quality by Design approach are in the limelight of current research trends.
Kovács Béla, Boda Francisc, Fülöp Ibolya, Székely-Szentmiklósi István, Kelemen Éva Katalin, Kovács-Deák Boglárka, Székely-Szentmiklósi Blanka   +6 more
doaj   +1 more source

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

European Standard Clinical Practice Guideline and EXPeRT Recommendations for the Diagnosis and Management of Gastroenteropancreatic Neuroendocrine Neoplasms in Children and Adolescents

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Pediatric gastroenteropancreatic neuroendocrine neoplasms (GEP‐NENs) are extremely rare and clinically heterogeneous. Management has largely been extrapolated from adult practice. This European Standard Clinical Practice Guideline (ESCP), developed by the EXPeRT network in collaboration with adult NEN experts, provides (adult) evidence ...
Michaela Kuhlen, Calogero Virgone, Antje Redlich, Michael Abele, Ricardo Lopez‐Almaraz, Tal Ben‐Ami, Ewa Bien, Gianni Bisogno, Maja Mazic Cesen, Andrea Ferrari, Malgorzata A. Krawczyk, Yves Reguerre, Dominik T. Schneider, Ines B. Brecht, Charlotte Rigaud, Bilgehan Yalcin, Rainer Claus, Christian Vokuhl, Constantin Lapa, Jörg Fuchs, Segolene Hescot, Thomas Walter, Julien Hadoux, Daniel Orbach   +23 more
wiley   +1 more source

Quality By Design: A Review

Journal of Drug Delivery and Therapeutics, 2022
Quality by Design is the most recent quality-related trend in pharmaceutical manufacturing (QbD). This paper discusses Pharmaceutical Quality by Design (QbD) as a way to guarantee high-quality pharmaceuticals. Details about Quality by Design are given in addition to a list of its components.
K. Devi, S Savitha
openaire   +1 more source

Health‐Related Social Needs in Children With Sickle Cell Disease Are Associated With Worse Health‐Related Quality of Life

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Background Children with sickle cell disease (SCD) face multiple acute and chronic medical complications that may impact their quality of life as reported by patients themselves. Health‐related social needs (HRSNs), such as food and housing insecurity, are common in people with SCD, but the association between HRSNs and patient‐reported ...
Sarah J. Marks, Molly Sonenklar, Cerelia Donald, Cecelia Valrie, Wally Smith, India Sisler   +5 more
wiley   +1 more source