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Phase I clinical trials, BE/BA study, general PK/PD

Clinical Trials >> Clinical Development / Phase IIb-IV >> Bioavailability / Bioequivalence

Phase I, namely BA and BE in healthy volunteers ~1000 square meters clinical department comprising 60 beds in two independent units. Dosing sessions in large groups (up to 60 subjects in parallel). GCP/GLP compliant. 16,000+ volunteers database.

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Biosimilars

Clinical Trials >> Clinical Development / Phase IIb-IV >> Bioavailability / Bioequivalence

Whatever Phase 1 clinical pharmacology study you require, at Quotient Sciences you can expect rapid study startup and rapid recruitment through our locations in Jacksonville, Miami and Nottingham.

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Bioavailability & Dose Proportionality

Clinical Trials >> Clinical Development / Phase IIb-IV >> Bioavailability / Bioequivalence

Whatever Phase 1 clinical pharmacology study you require, at Quotient Sciences you can expect rapid study startup and rapid recruitment through our locations in Jacksonville, Miami and Nottingham.

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Claims Substantiation & Efficacy Testing

Clinical Trials >> Clinical Development / Phase IIb-IV >> Bioavailability / Bioequivalence

Claims substantiation plays a key role in a product’s success and helps ensure the product stands out against competitors. From moisturization and barrier function, to anti-aging and color changes, rely on RCTS for your product claims substantiation and efficacy testing needs.

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Generic Drugs / Biosimilars

Clinical Trials >> Clinical Development / Phase IIb-IV >> Bioavailability / Bioequivalence

Celerion is participating in the emerging area of biosimilar drug development by leveraging biologics regulatory expertise, proven large molecule and immunogenicity bioanalytical support, clinical study planning and execution and biopharmaceutics program development.

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Biosimilars

Clinical Trials >> Clinical Development / Phase IIb-IV >> Bioavailability / Bioequivalence

Celerion leverages more than 30 years of biologics drug development experience to enable early assessment viability of biosimilars, and bridge the gap between newly sourced products and patient studies.

CRO’s with experience in providing biostatistical services, contractor selection and supervision with wide experience with biostatistics, pharmacokinetics, and bioanalytics. Bioavailability and Bioequivalence studies or Relative BE/BA studies can be Single & multiple dose studies, Food Effect studies, Cross over and parallel studies, Replicate studies. BA/BE studies are conducted in extremely controlled environment and all the clinical, bioanalytical and data management activities are strictly driven through SOPs. The studies are conducted as per the ethical committee approved protocol, SOPs, current GCP, GLP standards and applicable regulatory requirements. Bioequivalence studies have become an essential requirement for registering new pharmaceutical/biopharmaceutical products in markets across the world during clinical research or clinical trials. Strict adherence to GCP is practiced in overall conduct of all the studies(like ADME etc.) and conducting studies for various routes of delivery and formulations like Tablets, Capsules, Solutions, Suspensions, Syrups, Sprays, and Suppositories etc. has become a major pre-requisite for pharmaceutical companies. Bioanalytical department of major CRO’s are equipped with wide variety of analytical platform like LC/MS/MS, GC-MS-MS, ICP-MS, HPLCs, ELISA etc. The monitoring of all the steps of a BA/BE study aims to ensure that all study data is obtained and processed in compliance with the clinical protocol and local legislation, ensuring the participant’s well-being first and, consequently, good results for the pharmaceutical industry in charge and for the population who will soon have access to a new generic/biosimilar drug. These studies are also done for isotopically labelled drug. Fully integrated service for BE studies includes Relative bioavailability of established and experimental formulations, Single and multiple-dose (Steady state) kinetic studies, Fasting / Food-effect kinetic studies, Drug interaction studies, Studies comparing Immediate and modified release formulations, Pharmacodynamics studies, Studies comparing various Routes of Administration, Studies in Healthy Volunteers / Special Population, Oral Bioavailability studies, Absolute Bioavailability etc.

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