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| BA/BE Studies Services |
Bioequivalence and Bioavailability studies are one of the key services that we offer at our GCP/GLP compliant centre. The various studies on bioavailability, bioequivalence and pharmacokinetics on variety of dosage forms are conducted at our center in Faridabad, in strict compliance with national and international regulatory requirements.
FCRL’s bioanalytical services – from method development to method validation to sample analysis – are managed by highly trained and experienced scientists with more than 15 years of experience in the pharmaceutical industry.
All the critical steps of BA/BE studies undergo vigorous quality control checks to ensure data integrity and authenticity. Also all the studies are monitored by an independent quality assurance department.
Our expertise in bio-analytical services has ensured the development of over 130 validated bio-analytical methods in last few years and it is a continuous process where-in the analytical team keeps developing the method on demand. We have constituted a dedicated team to develop and validate new methods for BA/BE studies.
Our expertise in Bio Studies includes BA/BE Studies, Phase I Studies (conducted in healthy volunteers)andPK/PD Studies.
Capabilities
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Method development/validation for drug/metabolite(s) assays for pharmacokinetic studies |
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Methods for drug-drug interaction studies and multianalytes assays |
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Bioanalysis of drug and metabolites in a variety of biological matrices from preclinical and clinical trials |
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Ability to develop and validate highly sensitive assays in low pg/mL range |
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List of more than 130 validated methods |
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Ability to develop and validate methods well in advance based on patent expiry and business sense |
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Ability to accommodate projects with rapid turn-around-times |
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Qualified, trained & experienced team of bioanalytical professionals |
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| Sample Storage |
| All study samples are stored in secure freezers, controlled and continuously monitored and supported by a standby generator & UPS (Uninterrupted Power Supply) system. |
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Low temperature storage (-20°C and -70°C) |
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