EARLY PHASE RESPIRATORY DRUG DEVELOPMENT RAPID, FREQUENT AND REPRODUCIBLE PK DATA COLLECTION FOR RESPIRATORY STUDIES. Our dedicated purpose built Early Phase campus conducts First-in-Human (FiH) through to Proof of Concept (PoC) studies with healthy volunteer and patient populations. We can work with respiratory experts from academia, teaching hospitals and have a respiratory advisory board of Key Opinion Leaders (KoLs) to assist us in delivering high quality respiratory studies to meet your business objectives.
We understand the importance of frequent, multiple early time-point collection to capture peak plasma concentration (c-max) results. WE ACHIEVE >95% OF FREQUENT EARLY PK TIME POINTS BECAUSE OF OUR EXPERIENCED STAFF AND OUR PROCESSES: • Qualiﬁed teams trained and maintained to meet our high standards • <10% staff turnover; experience and training is retained • Average length of service per staff member 10+ years • Cross functional teams, including research nurses, research physiologists, and research technicians, play a role in the dosing team.
SCREENING AND STUDY PROCESS:
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OUR EXPERIENCE We have longstanding experience conducting research into new drugs and drug delivery systems designed for the treatment of a range of respiratory disorders including asthma, chronic obstructive pulmonary disease (COPD), idiopathic pulmonary ﬁbrosis (IPF) and allergic rhinitis, using a variety of tests and equipment including: • Influence of Lung Deposition Patterns on PK Profile
• Lung Imaging Using Gamma Scintigraphy
• Tolerability, Pharmacokinetics and Bronchodilatory Effects of Inhaled Solutions
• Evaluation of the Bronchodilator Profile in Patients With Chronic Obstructive Pulmonary Disease (COPD)
• Measurement of Intrapulmonary Deposition of Radiolabelled Formulations
• Assessment of the Upper Airways Using Acoustic Pharyngometry
• Pulmonary Drug Delivery Including Anti Sense Compounds And Inhaled Insulin
• AMP and Other Respiratory Challenge Testing
• Exhaled Breath Condensate Respiratory Function Testing Using Spirometry
• Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
• Eosinophil Shape Change by Flow Cytometry ‘State of the Art’ Dual Head Gamma Camera Located Within our Purpose-built Scintigraphy Suite
• Inhalation Chambers
GLP, GMP and GCP Accredited Facility
• Inhaled IMP Studies and Inhalation Device Studies
OUR LOCATION AND IMMEDIATE PATIENT POPULATIONS: Our clinical pharmacology unit is based in Wales in the United Kingdom. This region has a heavy industrial heritage and therefore high numbers of patients diagnosed with COPD, which currently affects1.8% of the population. It also has asthma levels equivalent to 6.9% of the total regional population, higher than the UK average. As such, there are active patient pathways to diagnose and treat respiratory patients. Simbec Research is liaising and working with KoLs, medics, and academics to support the highest calibre of innovation, translational research, and clinical care to improve health and wellbeing.
If you have a respiratory product earmarked for Early Phase Clinical research, we would like to discuss it with you... Talk to us by email contact@SimbecOrion.com. Or go to www.SimbecOrionCRO.com
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