Abstract
The rate and extent of absorption of a drug from its dosage form is referred to as bioavailability. While bioequivalence between two drug products is attained if their extent and rate of absorption do not relatively differ when administered at the same dose. A bioequivalence study comprises of two or more bioavailability studies which are performed by i) Measurement of active drug substance or its metabolites in the biological fluid; ii) Comparative pharmacodynamic studies in humans; iii) Comparative clinical trials; iv) Comparative in-vitro dissolution studies. The rationale of the study is the monitoring of the pharmacokinetic-pharmacodynamic parameters (AUC, Cmax) after administration of the tested drug. This study is not an experimental study but a form of data analysis and reporting of comparative bioavailability studies. The study data obtained is required to be equipped with applications of new drug products as notified in Schedule Y. Cumulatively, it aids in the development of pharmaceutical preparations in the pharmaceutical industry. This review article aims to illustrate the systematic overview of BA/BE study with an emphasis on its experimental aspects like study design, volunteer selection, dosing regimen, sample collection procedures along with a detailed insight on Informed Consent Document, Case Report Form, Trial Master file and the Protocol which collectively form the backbone of the clinical study.
Highlights
Clinical research is an organised study performed on human candidates to collect all the necessary data required for the discovery of new drug products or verification of clinical, pharmacological or adverse effects of API/formulations with the aim of determining the ADME profile of drugs.[1]
A period is defined as a sub-part of a phase of clinical trial, which includes single dosing followed by periodical sampling and observational time span to monitor the occurrence of adverse events/serious adverse events in the subject and lasts usually for 48 to 72 hr
Before clinical trial phase: This section will include the following data; Investigator’s brochure, qualification document of the investigator, documents approved by IRB/Independent Ethics Committee (IEC) and Regulatory Authority, Financial aspects of the trial, Insurance statements, signed agreement between the involved parties, signed protocol and Case Report Form (CRF) copy, Informed Consent Form, Master randomisation list, Decoding procedure for blinded trials, Trial initiation monitoring report, Normal ranges for medical or laboratory tests, Sample of label attached to the product container, instructions for handling of product and its shipping records
Summary
Clinical research is an organised study performed on human candidates to collect all the necessary data required for the discovery of new drug products or verification of clinical, pharmacological (pharmacokinetic/ pharmacodynamic) or adverse effects of API/formulations with the aim of determining the ADME profile of drugs.[1]. Indian Council Medical Research (ICMR) issued ethical guidelines for biomedical research on human subjects in 2000, closely followed by the Indian Good Clinical Practice (GCP)[17] by CDSCO in 2001.18 In the following years, Indian clinical research for Investigational New Drug (IND), witnessed a lag phase in which many leading companies did abandon drug development due to many factors like large investment costs, lack of necessary skill sets and multiple failures. CDSCO has set registration criteria for CROs with validity up to 5 years which is subject to re-registration (renewal) for further conduction of clinical trials
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