Phase I-IIa BA/BE
Phase I – IIa & Bioavailability and Bioequivalence Studies
We conduct
- FASTING STUDIES
- FOOD EFFECT STUDIES
- INTERACTION STUDIES
- MULTIPLE DOSE AND STEADY STATE STUDIES
- DOSE LINEARITY STUDIES
- INVITRO-INVIVO CORRELATION
- PK-PD MODELING
- DERMATOPHARMACOKINETICS
This full service covers study design, protocol & Informed consent form(ICF) development, CRF design, Ethics committee review, Selection of subjects, bioassay of drug / metabolite, Pharmacokinetic and statistical data evaluations, reporting of study results, and archiving of all study related data.
Synchron has 90 bedded at three different location in Ahmedabad. Each unit has adequate recreation facilities to conduct bio studies in healthy human volunteers, including women and post-menopausal women. We can conduct both male and female volunteer study simultaneously.
The BE & BA studies are carried out as per the appropriate SOPs.