BIOEQUIVALENCE STUDY
Fides Regulatory provides effective writing / reviewing the Bioequivalence Study as per WHO / Country specific guideline. Post sale, We provide cost-free support till product registration.
Email your BE requirements to dhaarmi@fidesregulatory.com / fidesraa@gmail.com - We will review your requirements and revert back to you ASAP. And will also Quote /provide sample documents on demand
PREPARE, REVIEW AND SUBMIT
Format : EU / WHO / Country specific guideline
BIOEQUIVALENCE STUDY:
We are allied with well recognized and reputed study centers which are approved from local regulatory body (DCGI) and other regulatory authorities (USFD, MHRA etc), to carry out BA / BE studies of various dosage forms.
We do:
BE Protocol Design and prepare BE report
Biostatics work and review of BE studies
Bioanalytical Protocol and report - Preparation and review
Biowaiver report - Preparation and review
We have experienced on more than 240 BE (US / EU)
Comparative in vitro dissolution testing
We perform Comparative in vitro dissolution testing and also provide report. It can use in case of biowaiver.
Three major factors that govern the rate and extent of drug absorption from immediate release (IR) solid dosage forms are the dissolution of the drug product, and the aqueous solubility and intestinal permeability of the drug substance. The Biopharmaceutical Classification System (BCS) classifies the active substance into one of four classes, depending on the level of solubility and the level of permeability. Combination of the dissolution of the drug product with the BCS classification of the drug substance provides the possibility to waive in vivo bioequivalence studies for certain categories of IR drug products.
