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Solutions for Early Phase Challenges


Where our accuracy and speed meets your complex challenge…and wins

Early Clinical Development Solutions

Through our purpose-built clinics and concentration on new technologies and processes focused on assisting you, we are able to offer solutions across a broad range of therapeutic areas and specialty testing. Our experience in early phase clinical development ensures that there is not much we haven’t seen and conquered. We are ready to help you with your early phase challenges.

Celerion has developed specific expertise in several therapeutic indications that are commonly evaluated in early phase clinical studies in association with the drug under study. The specialty areas include: cardiovascular safety studies; respiratory studies; and metabolic studies. In addition to these, Celerion has developed specialty testing techniques and processes to handle your most complex early phase study requirements.

 


Celerion Pharmacy Solutions

Celerion is the premier provider of early drug development solutions. Our pharmacists have more than 50 years of experience conducting clinical research and over a century of combined Phase 1 pharmacy staff experience.

Our onsite USP <795>, <797>, and <800> compliant compounding suites are fully equipped with specialized equipment for pharmaceutical compounding. We can perform both sterile and non-sterile drug preparations including API in capsule, oral solutions, oral suspensions, topical preparations, injectable, and inhaled dosage forms. Experience decreased startup timelines, decreased startup investment, flexibility with real-time dose adjustment, and high-quality compounding by a licensed pharmacist at Celerion.

See how we’re bringing you the future of pharmacy.

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Human Radiolabeled ADME Studies

Celerion has the capabilities to manage all aspects of human radiolabeled ADME studies from synthesis and formulation of an appropriate radiolabeled drug through dosimetry assessment and clinical conduct to final isolation, identification and quantification of metabolites in the samples collected. Celerion has access to a skilled radiochemical synthesis group as well as to specialists in metabolite isolation and identification from biomatrices. Radiolabel dosage forms, sterile and non-sterile, suitable for administration to humans can be readily prepared at Celerion’s purpose-built ADME compounding suite at our Lincoln facility. Our Lincoln clinic is one of the few global organizations that can conduct specialized human ADME studies to regulatory standards, including micro-radiotracer studies.

 


Ophthalmic Studies

In association with Queen’s University in Belfast, Celerion has expanded its expertise in performing precise ophthalmologic measurements as part of assessing the safety of new drug candidates. Moving beyond clinical safety assessment, we have the ability to focus on a variety of eye diseases such as diabetic retinopathy, age-related macular degeneration, glaucoma, and retinal vein occlusions.

Practical Regulatory Insight

Update and trends on pharmacokinetic studies in patients with impaired renal function

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