Pediatric Drug Development
How do I access customized solutions to meet my unique pediatric program needs?
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Pediatric formulation and product development
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.
Global patient clinical supplies
We manufacture, package, release and supply GMP drug products ready for dosing on a worldwide basis, in line with your study and recruitment needs. Our flexible options range from a personalized, per-patient basis to more traditional batch manufacturing.
Commercial manufacture
Our production facilities in Philadelphia are fully inspected and approved by FDA, EMA, PMDA and DEA and specialize in low volume products.
PIP/PSP regulatory support
We support regulatory processes for your Pediatric Investigation Plans and Pediatric Study Plans.
When you need flexible solutions for your pediatric drug development programs, Quotient is your answer.
Accelerating the development of new medicines for children
Our partnership with Pharmaceutical Product Development LLC (PPD) provides an innovative solution that offers industry-leading end-to-end support for all stages of pediatric drug development — from chemistry and manufacturing through all clinical trial phases, and on to commercial manufacturing.
Benefit from:
- Accelerated timelines, reduction of costs and easing of regulatory burden
- A single solution for an entire pediatric program, with only one contract and one point of contact
- Rapid development and clinical testing of pediatric formulations
- Comprehensive program design and regulatory support
- Combined global expertise in formulation, manufacture and clinical development of pediatric medicines
Related links
Learn more about pediatric drug development
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Info SheetTranslational PharmaceuticsQuotient Sciences helps you achieve your goals by enabling precise formulation development, streamlined manufacturing, quick pivot to clinical data and a significantly faster transition through drug development.
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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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Info SheetFormulation Development - Spray DryingWe use a broad range of formulation approaches to address complex solubility and bioavailability challenges, ensuring technology selection is driven by molecule need.
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Scientific PostersA Phase 1, Randomized, Double-Blind, Placebo Controlled, First-in-Human Study to Assess Safety, Tolerability & Pharmacokinetics (PK) of Amilo-5MER in Healthy Volunteers."A Phase 1, Randomized, Double-Blind, Placebo Controlled, First-in-Human Study to Assess Safety, Tolerability & Pharmacokinetics (PK) of Amilo-5MER in Healthy Volunteers." The poster was presented at the Pharmacology 2022 conference and was co-authored with our customer, Galmed Pharmaceuticals