12 / 92 resources displayed
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Whitepaper
Assessing the Financial Impact of Translational Pharmaceutics®
Tufts Center for the Study of Drug Development (CSDD) white paper sharing study results that indicate Quotient Sciences’ Translational Pharmaceutics® platform reduces development times by more than 12 months and lowers R&D costs by more than $100 million per approved new drug, compared to traditional multi-vendor development paradigms.
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Fact Sheet
Formulation Strategies for Poorly Soluble Molecules
With nearly 30 years of experience, Quotient has established a broad suite of technologies and formulation approaches to address these complex solubility challenges. Our approach allows us to dramatically speed up the optimization of your drug products to improve oral bioavailability.
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Scientific Posters
EuPFI 2019 - Development of Oral Liquid Products for Neonatal Patients
The objective of the development programme was to design an age - appropriate multi-dose liquid product suitable for the neonate population (up to 28 days old).
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Case Studies
Druggability Technologies
Druggability Technologies (DRGT) is developing DRGT-46 as a novel therapy for pain. Gabor Heltovics, CEO of DRGT, explains how Quotient Sciences enabled the rapid development, clinical assessment and commercial readiness of its DRGT- 46 product using integrated services across Quotient’s network of harmonized development and manufacturing sites in the UK and US.
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Webinar
From candidate selection through to proof-of-concept
Building a robust understanding of your API characteristics matched against your development programme goals, supports the efficient transition of drug products from candidate selection through to proof-of-concept. Starting @ 4pm (BST-UK), 11pm (ET), 8am (PT) and 6pm (BST-UK), 1pm (ET), 10am (PT)
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Fact Sheet
PBPK Modelling & Simulation
Quotient is a leading expert in the application of physiologically based pharmacokinetic (PBPK) modelling and simulation (M&S) science to drug development. Using GastroPlus™ we advise our clients on the potential in vivo performance of drugs and formulations to inform product and clinical development strategies.
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Scientific Posters
How do I quickly develop first-in-human (FIH) dosage forms and avoid CMC delays whilst achieving proof-of-concept (POC)?
Choosing the appropriate dosage form for first-in-human/Phase I trials Pharmacy preparation or GMP manufacturing? Bridging to robust and scalable Phase II drug products Flexible and adaptive clinical manufacturing strategies for patient trials Integrating pharmaceutical sciences and clinical testing
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Webinar
Accelerating drug product development from early phase to scale up and commercialisation
This webinar covers a real-world case study with Druggability Technologies, a specialty pharmaceutical company, which utilized Quotient’s integrated approach to advance the development of DRGT-46, a novel, fast-acting formulation of celecoxib, using proprietary super-API compositions developed by DRGT.
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Whitepaper
Application of a Novel ‘Make and Test in Parallel’ Strategy to Investigate the Effect of Formulation on the Pharmacokinetics of GDC-0810 in Healthy Subjects
GDC-0810, administered orally, was used in Phase I and II clinical studies to treat estrogen receptor positive breast cancers.
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Scientific Posters
Phase 1/1b study of inhaled formulation in healthy volunteers & asthmatics
PUR1900 is an iSPERSE™ formulation incorporating a large, complex anti-fungal compound that can be administered at high therapeutic dose to the lung while minimizing systemic side effects. Patients with severe asthma and CF are afflicted with ABPA, a complex hypersensitivity reaction that occurs in response to colonization of the airways with Aspergillus fumigatus. This Phase I study was designed to evaluate the safety, tolerability and PK of single and multiple ascending doses of PUR1900 capsules administered as dry powder for inhalation in Part 1 (single ascending dose; SAD) and Part 2 (multiple ascending dose; MAD) respectively, in healthy volunteers.
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Scientific Posters
A pharmacokinetics and lung deposition study in healthy volunteers
The results of this study demonstrate that CMS delivered as ColistAir has a comparable safety profile to the comparator products and is well tolerated in healthy volunteers.
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Scientific Posters
Rapid Development and Clinical Assessment of New Rectal and Oral Formulations for Ulcerative Colitis Using Real-Time Adaptive GMP Manufacturing and Supply
TOP1288 is a non-systemic kinase inhibitor (NSKI) being developed as a treatment for patients with ulcerative colitis. As a novel, locally-acting candidate, TOP1288 has low systemic bioavailability and therefore a dual-pronged formulation strategy was adopted with rectal and oral formulations being developed.