Comparative analysis of biopharmaceutic classification system (BCS) based biowaiver protocols to validate equivalence of a multisource product

Abstract

Biopharmaceutic classification system (BCS) is a substantial part of drug designing and generic product development and has been accepted as a technique to renounce in-vivo pharmacokinetic evaluation (biowaiver). It appeared to be worthwhile and time-saving by means of in-vitro studies in the presence of biorelevant physiological mediums that mimic not only the predictable solubility but also permeability of the multisource product. Such methodology is now applied as a regulatory stamp to support new and generic product approvals based on other than in-vivo equivalence testing. This article outlines the foundation of BCS, its implementation in granting biowaiver, adequacy of in-vitro bioequivalence studies, principles and requirements of BCS biowaiver by four regulatory agencies such as; Food and Drug Authority (FDA), World Health Organization (WHO), European medicine agency (EMA) and International Conference on Harmonization (ICH), potential effect of excipients on solubility and permeability of drug molecules and supplementary data provided by FDA regarding biowaiver approvals. Furthermore, supportive data provided by the International Pharmaceutical Federation (FIP) has also been given for biowaiver sanction of certain drug products. It has been concluded, that although biowaiver is a profitable methodology for generic and new drug product approval, the variance in the standards of governing bodies demands more critical assessment to establish some unified principles to be followed globally.

Manufacturing and Examination of Vaginal Drug Delivery System by FDM 3D Printing

“…The resistance development is small-scale compared to other antibiotic agents [ 16 , 17 ]. The API belongs to class III according to the Biopharmaceutical Classification System (BCS) [ 18 ]. The most important concerns that limit the utility of this antibiotic are the adverse effects, such as neurotoxicity, bone marrow depression and in some cases, severe aplastic anemia [ 19 ].…”

Дослідження Профілів Розчинення Таблеток Амлодипіну З Еналаприлом

“…Якщо активний фармацевтичний інградієнет вивільняється на 85 % за 30 хв., потрібне оцінювання профілів вивільнення, то фактор подібності має складати більше ніж 50 %. Процедура «біовейвер» надає вичерпну інформацію про допоміжні речовини, які входять до складу лікарського засобу (Farah et al, 2020;Melian et al, 2021).…”

“…Еналаприл є антигіпертензивним засобом та використовується для профілактики серцевої недостатності, дисфункції лівого шлуночка. За рахунок швидкого розкладання в організмі на еналаприлат, що є сильним інгібітором ангіотензин-перетворюючого ферменту, еналаприл діє на ренін-ангіотензин перетворюючу систему (Faruqi & Jain, 2021;Verbeeck et al, 2017].…”

The Evaluation of Some Brands of Levocetirizine Dihydrochloride Film-Coated Tablets for Quality and Equivalence Sold in Aden, Yemen

“…The use of f1 and f2 is simple and gives reliable results, as well as being commonly used and the most recommended method by the FDA. However, the similarity factor (f2) is the most appropriate method to compare release profiles [6,21]. It evaluates the degree of similarity between the two profiles and is sensitive to significant variations at any time point [5].…”

“…For immediate release, solid oral dosage forms with fast invitro dissolution are acceptable surrogates for determining the bioequivalence of generics with innovator drugs. The bioequivalence of class I and some class III drugs, such as levocetirizine dihydrochloride, can be determined only by the in-vitro dissolution test [5,6]. The dissolution test is a tool for distinguishing acceptable from unacceptable products.…”