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Promote Safe, Clinically Advanced Phase I Studies
To achieve the objective of safely advance the drug candidate through phase I study we focus on maximizing critical data through strategic study design ensuring subject safety and efficiently capturing quality PK and PD data in phase 1 research.
Clinical Pharmacology:
Clinical Pharmacology – Scientific Steps in Safety
To move from Phase I to Phase II and then to guide the dosing-regimen design for Phase III studies, that need to:
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Promote the safety of your drug by maximizing the benefits and minimizing the side effects |
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Effectively communicate with regulatory agencies |
We provide the full spectrum of Pharmacokinetic (PK) / Pharmacodynamic (PD) services – from coordinating First-in-Human studies to negotiating pharmacokinetics labeling. With our scientists, we work to:
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Integrate early development PK/PD data to design First-in-Human studies and support registration, including estimating doses |
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Assess Phase I safety/dose tolerance |
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Prepare components of IND, CTD, and NDA submissions |
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Perform PK/PD modeling to guide dosing-regimen design for Phase III studies |
Clinic Profile:
The Volunteer’s Clinical Experience
To provide a safe environment and a rewarding experience for healthy volunteers during clinical trials, with 78 beds facility FCRL delivers that atmosphere, drawing on more than 5 years' experience handling BA/BE & Phase I clinical research.. We employ full-time physicians, a team of RN/BSN nurses and pharmacists to oversee the conduct of all studies. Our clinics specialize in:
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Drug interaction studies |
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Age and gender studies |
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First in man single and multiple dose administration & studies |
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Women’s health studies |
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One to 45-day housed, multidose studies |
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