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Webinar
Translational Pharmaceutics and the Benefits of Real-Time Adaptive Manufacturing
This webinar explains the benefits of Translational Pharmaceutics, a unique approach which integrates formulation development, real-time adaptive GMP manufacturing and clinical research. It will illustrate how, by breaking down the siloes and integrating horizontally, we can operate with more flexibility in the early phases of drug development, reducing costs and shortening timelines.
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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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Webinar
Integrated Early-Stage Drug Development and Manufacturing: Accelerating Molecules to Proof-of-Concept
This webinar highlights how by breaking down the barriers between traditional outsourcing channels and workflows, drug development activities and key functional groups including formulation development, manufacturing and clinical research can be much more closely integrated to accelerate early-stage drug development, reduce overall expenditure and shorten time to proof of concept.
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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
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.
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Fact Sheet
First-in-Human to Proof-of-Concept
Our Translational Pharmaceutics approach enables First-in-Human studies by re-engineering the transition of your drug molecule into clinical development and shortening the timeline to Proof-of-Concept.
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Fact Sheet
PPD & Quotient Pediatric Partnership
Through our partnership with PPD, we can provide one solution to execute an entire pediatric program with the potential for one contract and a single point of contact.
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Webinar
Considerations for First-In-Human Clinical Trials: Planning for Success
The First-in-human (FIH) clinical trial is a pivotal milestone in the drug development process and is the stage-gate before molecules can proceed to Phase II/proof of concept trials.