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Scientific Posters
Development of a Modified Release Tablet Containing an API Prone to Form Changes and Gelling in Aqueous MediaChing
Development of an MR formulation of Cmp-1 was planned using RapidFACT®: an integrated approach that allows formulation optimization based on human PK data with an adaptive clinical design. Selection of a discriminatory in vitro dissolution test was an important early development activity.
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Scientific Posters
Evaluation of Process Transferability of Poorly Flowing Blend Between the Blenders Manufactured by Different Vendors
The objective of the study is to evaluate the overall risk on the process transferability of a poorly flowing blend between two (2) - 10 cu.ft V blenders manufactured by different vendors.
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Scientific Posters
Development of a Palatable Glycopyrronium Bromide Liquid for Paediatrics
The aim of the development program was to develop an aqueous, multidose oral liquid formulation of glycopyrronium bromide 2mg/5ml for the symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in paediatric patients aged 3 years and older with chronic neurological disorders.
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Scientific Posters
An Open-label, Two-period Study Designed to Evaluate and Compare the Mass Balance Recovery and Metabolite Profile of 14C-Deutetrabenazine and 14C-Tetrabenazine in Healthy Male Subjects
Deutetrabenazine (Austedo, Teva) is approved for the treatment of chorea associated with Huntington’s disease (HD) and tardive dyskinesia (TD). Deutetrabenazine is the first deuterated product approved by the FDA and only the second product approved in HD and TD. Deutetrabenazine is a novel VMAT2 inhibitor that is structurally related to tetrabenazine, with two trideuteromethoxy groups at the 9- and 10-positions in tetrabenazine
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Scientific Posters
Development and optimization of MR formulations in the absence of predictive laboratory or preclinical models
The integration of formulation design space, real-time GMP manufacturing, and an iterative sequential pharmacokinetic (PK) study in healthy volunteers was successfully applied to develop an HPMC matrix tablet that achieved the desired PK characteristics for SLx-2101.The key formulation variables influencing performance were the range of dose and release rate, hence a two-dimensional (2D) design space was mapped by manufacturing and characterizing four “regulatory batches” bracketing the corners of the compositional ranges.
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Scientific Posters
Application Of Non Standard Approaches To Investigations Of Human Mass Balance And Metabolite Characterisation
Conventional human metabolism studies are well understood study designs which help drug companies generate data to support drug development and registration. Variations from conventional study designs can be required as a result of the specific characteristics of individual drugs or the need for particular data to support drug registration. This poster describes scenarios where alternative study designs and approaches have been required.
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Fact Sheet
Translational Pharmaceutics
Translational Pharmaceutics innovates the way you design and implement your drug development program and is proven to reduce drug development costs and shorten timelines.
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Scientific Posters
An Evaluation of the Pharmacodynamics, Safety, and Tolerability of the Potassium Binder RDX7675
The aim of the phase 1, single-center, randomized, active-controlled study in healthy volunteers reported in this paper was to investigate the pharmacodynamic effects and safety of different dosing regimens of RDX7675 in humans.
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Fact Sheet
Global Formulation Development and Manufacturing Capabilities
We provide full service support for small molecule non-sterile programs, from dosage formulation development through to GMP clinical trial manufacturing and commercial drug product supply.
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Fact Sheet
Formulation Development
From preclinical and first-in-human (FIH) dosage forms to optimization of your drug products for late stage development, we work with you to develop the most appropriate formulation.
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Fact Sheet
Clinical Pharmacology
When you are looking for a partner who is dedicated to Phase I trials and early development, rely on Quotient Sciences. We accelerate your molecule from first-in-human to proof-of-concept, helping you make critical decisions earlier.
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Fact Sheet
Pediatric Development
Our expertise and capabilities enable us to meet the complex technical challenges of pediatric products and provide you with a unique integrated development solution.