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.