BIOAVAILABILITY/
BIOEQUIVALENCE
Bioavailability/Bioequivalence
Established and Reliable
Integrated, innovative, and nimble is our identity in this field
We conduct BA/BE studies in compliance with the relevant guidelines, both Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). It is our commitment to assist every customer in maximing the chances of bioequivalence result while meeting the tight timeline. Hence Equilab collaborates closely with the authority and operates agilely with the support of our team and facility.
Customer focus
Equilab focuses on delivering best service by managing an adaptive solutions-focus operations in our 75 beds, 2 clinical sites, 7 LCMS/MS(s), 4 HPLC(s), Spectrophotometer, dissolution tester, and other proponent facility.
End-to-End Services:
BA/BE Studies
-
Product discussion – comparative dissolution and laboratory evaluation review
-
Comparator product search and procurement support
-
Protocol development and regulatory/ethics submission
-
Analytical method development and validation
-
Clinical project planning
-
Subject screening, recruitment, and management
-
Adverse event resolution and reporting
-
Dosing and monitoring
-
Blood samples collection and storage
-
Bioanalytical method validation
-
Samples analysis
-
Quality assurance on clinical and bioanalysis process
-
Data management and statistical analysis
-
Data simulation for pivotal/additional study
-
Intensive discussion and consulation before, during, and after study
-
Facilitate regulatory review and registration
-
Knowledge sharing/socialization on BA/BE study (critical points, key take outs, lesson learned)