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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
A phase 11b study of an inhaled formulation of itraconazole in healthy volunteers and asthmatics
This study was conducted to evaluate safety, tolerability and pharmacokinetics of PUR1900 in healthy volunteers and asthmatics.
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Scientific Posters
A pharmacokinetics and lung deposition study in healthy volunteers comparing the delivery of colistimethate sodium (cms) when administered as an investigational new combination product
The results of this study demonstrate that CMS delivered as ColistAirTM 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.
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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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Webinar
Pediatric Drug Development: Unique Considerations and Challenges
This webinar will explore product considerations when designing pediatric pharmaceutical products, clinical and operational considerations when executing and designing clinical trials for pediatric patient populations and regulatory considerations for pediatric drug development including US and EMEA incentives, guidance and requirements.