Results 41 to 50 of about 11,237,275 (282)

Risk-Based Approach for Defining Retest Dates for Active Pharmaceutical Ingredients and Excipients

Pharmaceuticals
Drug substances and excipients must be stored in recommended storage conditions and should comply with their specifications during the retest period for their use in the manufacture of drug products.
Naseem A. Charoo, Omotayo Akanji, Ziyaur Rahman, Aqeel A. Khan, Aqal Badshah   +4 more
doaj   +1 more source

A general evidence-based sequence variant control limit for recombinant therapeutic protein development

mAbs, 2020
Sequence variants (SVs) resulting from unintended amino acid substitutions in recombinant therapeutic proteins have increasingly gained attention from both regulatory agencies and the biopharmaceutical industry given their potential impact on efficacy ...
Aming Zhang, Zhengwei Chen, Meinuo Li, Haibo Qiu, Shawn Lawrence, Hanne Bak, Ning Li   +6 more
doaj   +1 more source

Spectra selection methods: A novel optimization way for treating dynamic spectra and in-line near infrared modeling [PDF]

Journal of Innovative Optical Health Sciences, 2020
Near infrared (NIR) spectroscopy is now widely used in fluidized bed granulation. However, there are still some demerits that should be overcome in practice. Valid spectra selection during modeling process is now a hard nut to crack.
Haiyan Wang, Ronghua Liu, Lei Nie, Dongbo Xu, Wenping Yin, Lian Li, Hengchang Zang   +6 more
doaj   +1 more source

Macro- and Micro-Heterogeneity of Natural and Recombinant IgG Antibodies

Antibodies, 2019
Recombinant monoclonal antibodies (mAbs) intended for therapeutic usage are required to be thoroughly characterized, which has promoted an extensive effort towards the understanding of the structures and heterogeneity of this major class of molecules ...
Alain Beck, Hongcheng Liu
doaj   +1 more source

Classification of quality attributes

, 2007
Purpose – The purpose of this paper is to investigate whether the different approaches to the classification of quality attributes deliver consistent results.
Löfgren, Martin,, Witell, Lars,
core   +1 more source

Evidence‐Informed Multidisciplinary Consensus Guidance for the Psychosocial Care of Adolescents With High‐Risk Cancer: Recommendations From the Italian Association of Pediatric Hematology and Oncology

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Background Adolescents with high‐risk cancer face complex developmental, psychosocial, and ethical challenges that extend beyond disease‐directed treatment. Although international recommendations exist for communication, psychosocial care, pediatric palliative care, survivorship, and shared decision‐making, these have largely evolved within ...
Johanna M. C. Blom, Dorella Scarponi, Giulia Zucchetti, Teresa Perillo, Maria Montanaro, Elisa Marconi, Chiara Rutigliano, Paolo Colavero, Paola Quarello, Marina Bertolotti, Monica Cellini, Carlo Clerici, Maurizio Mascarin, Francesca Bomben, Andrea Ferrari, the expert workgroup   +15 more
wiley   +1 more source

Critical Quality Attributes of Control Drug Release Systems and Their Impact on Rational Polymer Selection

, 2017
The aim of this paper is to select the appropriate polymer for the soluble agents encapsulation as Naloxone HCl, by understanding the impact of formulation on the critical quality attributes (CQAs) using a quality-by-design approach.
María Cristina Benéitez, María Esther Gil-Alegre, Gil Alegre, María Esther, Benéitez García, María Cristina   +3 more
core   +1 more source

Lecturer's pedagogical attributes and teaching quality for construction and engineering education in UK universities: mediating effect of research informed teaching

, 2023
Purpose Researchers have opined that the quality of commitment to pedagogical approaches by lecturers is one of the most important factors in determining student academic success.
Paul Esangbedo, Dubem Ikediashi, Afolabi Dania, Sani Reuben Reuben Akoh, Cletus Moobela, Nimi Dan-Jumbo, Kenneth Leitch   +6 more
core   +1 more source

Examining In Situ Acoustic Conditions for Enhanced Occupant Satisfaction in Contemporary Offices

Buildings, 2022
Indoor acoustic quality is one of the critical indicators for occupants’ health, comfort, and productivity in contemporary office environments. Post-occupancy evaluation (POE) is usually employed to examine in situ acoustic measurements to ensure indoor ...
Jihyun Park, Vivian Loftness, Tsung-Hsien Wang   +2 more
doaj   +1 more source

Central Nervous System Tumors Among Infants in Canada: A Report From CYP‐C

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Background Central nervous system (CNS) tumors in infants are rare, pose unique clinical challenges, and lack large‐scale evidence‐based data to guide management. This study seeks to describe CNS tumors in Canadian infants and to compare their outcomes with those of older children.
Samuel Sassine, Hallie Coltin, Sylvia Cheng, Lucie Lafay‐Cousin, Vanan Issai Magimairajan, Craig Erker, Stéphanie Vairy, Lynette Bowes, Adam Fleming, Donna Johnston, Sarah McKillop, Roona Sinha, Julie Bennett, Christina Coleman, Laura Wheaton, Shayna Zelcer, Samuele Renzi, Thai Hoa Tran   +17 more
wiley   +1 more source