Bioequivalence Study: Understanding Your Critical Phase 1 Clinical Trial Designs

Author : mariabrownema
Publish Date : 2021-03-08 05:59:25
Bioequivalence Study: Understanding Your Critical Phase 1 Clinical Trial Designs

Drug development is a time-taking and expensive process that is often marked by a high failure rate. Hence, early-stage analysis and bioequivalence clinical trial of the drug is essential. Bioequivalence and bioavailability study determine the primary phase of drug research and development. It evaluates the risk factors, safety, tolerability, and pharmacokinetic property of a compound. 

The main objective of conducting BE studies during clinical trials is to regulate and compare the systemic exposure of a test drug to that of a reference drug. In a bioequivalence study, a biological matrix is used to plot a time curve and assess the extent of the absorption rate of a drug. Measurement of BABE studies in clinical research is vital to support data in a regulatory submission. 

Phases in Clinical Trial Designs

The performance of clinical trials involving BABE studies takes place in a logical sequence. The process starts with identifying specific target populations, regulating ascending doses of single and multiple forms, followed by a subsequent preliminary examination of drug exposure. The last stages of development encapsulate pharmacokinetic assessments, evaluation of toxicity, and end with potential drug-drug interactions. The first bioequivalence clinical trials also set an objective for phase II clinical trials.

The mechanism is elucidated based on oral dosage and its disposition to the target site for drugs that are orally administered. After the successful completion of clinical trials, the FDA evaluates all the generic versions of the drugs. The fulfilment of approval of the drug is under the conditions that the active drug ingredient or API in the test compound is statistically equivalent to the original brand-name drug. 

FDA also makes sure that the manufacturing practices for the bioequivalence studies for generic drugs are as per GMP. The generic drug should also differ from its brand counterpart in colour, shape, and size.

Evaluation of Characteristics in Bioequivalence Studies

There are different parameters to determine bioequivalence study based upon formulations of the active drug moiety in the plasma co-related with time. Quantification of enantiomers in bioequivalence studies exhibits safety activity and PK/PD feature of the test compound. The parameters of bioequivalence include- Cmax, Tmax, and AUC. 


The designs of phase 1 clinical studies keep changing depending on the drug and its metabolites. Sometimes the generic version may not be equivalent to a brand-name drug and can be used as a substitute.

Even if there is not much difference between the two drugs' moiety, a slight concentration of API difference can make a significant distinction in drug effectiveness in circulation. Hence, the administration of drugs is in sizeable amounts studied peculiarly for their mode of action and efficacy after consumption by humans. For bioequivalence testing studies in the submission of ANDA that have been impacted by COVID-19, FDA recommends prioritizing the safety and protection of participants, as well as that of the personnel that must conduct and monitor such studies.

The aim and purpose of the bioequivalent testing are continuously evolving. The BE studies are fundamental to drug development, testing and research as they expedite the manufacturing of drugs and reduce the expense of generic drugs reaching the masses.

Category : health

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