Pediatric Development
The development of acceptable, palatable pediatric formulations is a key feature within the industry today, driven by patient needs and regulatory requirements. Quotient Sciences has extensive knowledge and capabilities that enable us to provide you with a unique integrated pediatric development solution.
Pediatric formulation development
Our scientists have considerable experience in developing palatable formulations in the OTC/consumer health care industry and have successfully developed customized pediatric pharmaceutical formulations which have received regulatory approval.
Taste masking
We have an extensive track record developing age-appropriate dosage forms of aversive, bitter drug substances using a range of taste-modifying and taste-masking techniques without compromising on product stability and PK performance.
Taste assessment and PK studies
Using our integrated GMP manufacturing and clinical testing platform, we perform rapid, adaptive trials in humans to optimize taste attributes and/or PK performance to ensure clinical validation prior to proceeding to pivotal pediatric trials.
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Scientific PostersDevelopment and Approval of a Palatable Glycopyrronium Bromide Liquid Formulation for PediatricsChronic drooling or sialorrhoea is evident in the pediatric population and is particularly prominent in those who suffer with neurological disorders such as cerebral palsy.
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Info SheetPediatric DevelopmentOur expertise and capabilities enable us to meet the complex technical challenges of pediatric products and provide you with a unique integrated development solution.
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Scientific PostersEnabling Clinical Assessment of Maralixibat for Rare Pediatric Liver Disease via Real Time Adaptive GMP Manufacturing - AAPS 2017A flexible, real-time adaptive GMP manufacturing model is required to support the increasing requirement for clinical trial conduct in small patient populations with challenging trial designs and treatment algorithms.
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Case StudiesEndevica Case Study - Peptide Program using Translational PharmaceuticsEndevica Bio is developing TCMCB07 as a novel synthetic peptide product for the potential treatment of cachexia. Read how they leveraged the Quotient Sciences Translational Pharmaceutics platform for this program.