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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 will cover 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.
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Scientific Posters
Identification and Optimization of Critical Process Parameters of Roller Compacted Capsules: From Development to Registration Batches
The main objective of the study is to apply the principles of QbD (Quality by Design) utilizing a predetermined risk-based approach to identify and optimize the Critical Process Parameters (CPPs) of roller compacted capsule product ensuring minimum impact on the Critical Quality Attributes (CQAs) to provide a product with desired quality.
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Scientific Posters
Development and Approval of a Palatable Glycopyrronium Bromide Liquid Formulation for Pediatrics
Chronic 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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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
Creating Acceptable Tablets (CAT) -A feasibility study to assess the swallowability and acceptability of different sized placebo tablets in children and young people: an interim analysis
The administration of medicines to children and young people (CYP) poses a challenge to many parents and health care professionals; this is linked to the limited information available for age-appropriate oral formulations.
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Scientific Posters
Developing spray dried dispersions for early phase clinical trials and beyond
Formulation strategies and the DevelopabilityClassification System (DCS). Benefits of spray-drying to address poor drug solubility. Fit-for-purpose systems in early clinical research and effectively transitioning to solid oral dosage forms. Adaptive clinical manufacturing “tailored” to the clinical study and patient recruitment.