Biopharmaceutics Classification System: Validation and Learnings of an in Vitro Permeability Assay

2008 ◽  
Vol 6 (1) ◽  
pp. 11-18 ◽  
Author(s):  
Victoria E. Thiel-Demby ◽  
Joan E. Humphreys ◽  
Lisa A. St. John Williams ◽  
Harma M. Ellens ◽  
Nipa Shah ◽  
...  
Keyword(s):  
Classification System ◽  
Biopharmaceutics Classification System ◽  
System Validation ◽  
Biopharmaceutics Classification ◽  
Permeability Assay

scholarly journals ICH Guideline for Biopharmaceutics Classification System-Based Biowaiver (M9): Toward Harmonization in Latin American Countries

Pharmaceutics ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 363
Author(s):  
Claudia Miranda ◽  
Alexis Aceituno ◽  
Mirna Fernández ◽  
Gustavo Mendes ◽  
Yanina Rodríguez ◽  
...  
Keyword(s):  
Latin American ◽  
Classification System ◽  
Biopharmaceutics Classification System ◽  
In Vitro Dissolution ◽  
Ich Guidelines ◽  
Latin American Region ◽  
Regulatory Guidelines ◽  
Biopharmaceutics Classification

The biopharmaceutical classification system (BCS) is a very important tool to replace the traditional in vivo bioequivalence studies with in vitro dissolution assays during multisource product development. This paper compares the most recent harmonized guideline for biowaivers based on the biopharmaceutics classification system and the BCS regulatory guidelines in Latin America and analyzes the current BCS regulatory requirements and the perspective of the harmonization in the region to develop safe and effective multisource products. Differences and similarities between the official and publicly available BCS guidelines of several Latin American regulatory authorities and the new ICH harmonization guideline were identified and compared. Only Chile, Brazil, Colombia, and Argentina have a more comprehensive BCS guideline, which includes solubility, permeability, and dissolution requirements. Although their regulatory documents have many similarities with the ICH guidelines, there are still major differences in their interpretation and application. This situation is an obstacle to the successful development of safe and effective multisource products in the Latin American region, not only to improve their access to patients at a reasonable cost, but also to develop BCS biowaiver studies that fulfill the quality standards of regulators in developed and emerging markets.

scholarly journals COMPARISON OF GLOBAL REGULATORY GUIDELINES FOR AVAILABILITY OF DIFFERENT BIOWAIVER PROVISIONS AND APPLICATION REQUIREMENTS OF BIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS) BASED BIOWAIVER.

2018 ◽  
Vol 3 (3) ◽  
pp. 8-20
Author(s):  
Jimi Patel ◽  
Priti Mehta ◽  
Vaishali Kothari
Keyword(s):  
Development Strategy ◽  
Classification System ◽  
Drug Application ◽  
Biopharmaceutics Classification System ◽  
New Drug ◽  
Novel Approach ◽  
Permeability Study ◽  
New Drug Application ◽  
Biopharmaceutics Classification

To waive a complete and systemic Bioequivalence (BE) study, Biowaiver or Request for a Biowaiver is a fast track approach to boost the drug development process. Over the past three-four years the Biowaiver market shows greater number of Biowaiver submissions and the wider use of In-vitro permeability study. Biowaiver is a beneficial approach for getting approval of Abbreviated New Drug Application (ANDA) while, BCS based Biowaiver is the novel approach to gain approval for New Drug Application (NDA) as well as ANDA. A Biopharmaceutics Classification System (BCS) based Biowaiver is an exemption from conducting human bioequivalence studies when active ingredient and dosage form meet criteria of solubility, permeability and dissolution. The Paper covers different kind of Biowaiver approaches and the criteria for the applicability of BCS based Biowaivers in the different geographic scopes with regard to global development strategy. There is a comparison of global guidelines on provisions availability for different types of Biowaiver approaches as well as for requirements of Biowaiver based on BCS. From comparison of different global guidelines it is reviewed that most of the guidance resembles to the USFDA, EU and WHO guidelines because most of the regulatory authorities are following the BCS based Biowaiver concept as one of the three main guidance documents (USFDA, EMA, WHO) or a combination of specific requirements.

scholarly journals Caco-2 Cells, Biopharmaceutics Classification System (BCS) and Biowaiter

2011 ◽  
Vol 54 (1) ◽  
pp. 3-8 ◽  
Author(s):  
Libuše Smetanová ◽  
Věra Štětinová ◽  
Zbyněk Svoboda ◽  
Jaroslav Květina
Keyword(s):  
Drug Absorption ◽  
Classification System ◽  
Drug Transport ◽  
Biopharmaceutics Classification System ◽  
Phenol Red ◽  
Basolateral Side ◽  
Free Transport ◽  
Biopharmaceutics Classification

Almost all orally administered drugs are absorbed across the intestinal mucosa. The Caco-2 monolayers are used as an in vitro model to predict drug absorption in humans and to explore mechanism of drug absorption. The Caco-2 cells are derived from a human colon adenocarcinoma and spontaneously differentiate to form confluent monolayer of polarized cells structurally and functionally resembling the small intestinal epithelium. For studying drug permeability, Caco-2 cells are seeded onto the Transwell inserts with semipermeable membrane and grown to late confluence (21 days). After determination of cell viability, the integrity of monolayer is checked by phenol red permeability and by 14C-mannitol permeability. The transport from apical to basolateral (AP-BL) and basolateral to apical (BL-AP) is studied by adding the diluted drug on the apical or basolateral side and withdrawing the samples from the opposite compartment, respectively, for HPLC analysis or liquid scintillation spectrometry. Ca2+- free transport medium is used to determine paracellular component of the drug transport. On the basis of permeability and solubility, drugs can be categorized into four classes of Biopharmaceutics Classification System (BCS). For certain drugs, the BCS-based biowaiver approach can be used which enables to reduce in vivo bioequivalence studies.

scholarly journals Overview on Biopharmaceutics Classification System (BCS) based biowaiver requirements in African countries

2021 ◽  
Vol 9 (2) ◽  
pp. 26-29
Author(s):  
Nidhi Sagar ◽  
Iva Dhulia ◽  
Himani Patel ◽  
Umesh Dobariya ◽  
Sandip Sarvaiya
Keyword(s):  
Classification System ◽  
Aqueous Solubility ◽  
Pharmaceutical Product ◽  
Biopharmaceutics Classification System ◽  
In Vivo Studies ◽  
Pharmacokinetic Studies ◽  
African Countries ◽  
Biopharmaceutics Classification

Biopharmaceutics Classification System (BCS)-based biowaiver are meant to reduce the need for establishing in vivo bioequivalence in situations where in vitro data may be considered to provide a reasonable estimate of the relative in vivo performance of two products. The BCS is a scientific approach designed to predict medicinal absorption based on the aqueous solubility and intestinal absorptive characteristics of the Pharmaceutical product. To ensure interchangeability, the multisource product must be therapeutically equivalent to the comparator product. Types of in vivo equivalence studies include comparative pharmacokinetic studies, comparative pharmacodynamic studies and comparative clinical studies. This article briefly explains the BCS based biowaiver requirements in six major African countries i.e. Zimbabwe, South Africa, Uganda, Kenya, Botswana and Tanzania which facilitates regulatory medicine approval process when the dossier (application) is approved based on evidence of equivalence other than In vivo studies.

scholarly journals Biopharmaceutics classification system: importance and inclusion in biowaiver guidance

2015 ◽  
Vol 51 (1) ◽  
pp. 143-154 ◽  
Author(s):  
Lorena Barbosa Arrunátegui ◽  
Neila Márcia Silva-Barcellos ◽  
Karime Rezende Bellavinha ◽  
Lisiane da Silveira Ev ◽  
Jacqueline de Souza
Keyword(s):  
Classification System ◽  
Low Cost ◽  
Drug Efficacy ◽  
Immediate Release ◽  
Pharmacological Therapy ◽  
Biopharmaceutics Classification System ◽  
Oral Dosage ◽  
Biopharmaceutics Classification

Pharmacological therapy is essential in many diseases treatment and it is important that the medicine policy is intended to offering safe and effective treatment with affordable price to the population. One way to achieve this is through biowaiver, defined as the replacement of in vivo bioequivalence studies by in vitro studies. For biowaiver of new immediate release solid oral dosage forms, data such as intestinal permeability and solubility of the drug are required, as well as the product dissolution. The Biopharmaceutics Classification System (BCS) is a scientific scheme that divides drugs according to their solubility and permeability and has been used by various guides as a criterion for biowaiver. This paper evaluates biowaiver application, addressing the general concepts and parameters used by BCS, making a historical account of its use, the requirements pertaining to the current legislation, the benefits and risks associated with this decision. The results revealed that the use of BCS as a biowaiver criterion greatly expands the therapeutics options, contributing to greater therapy access of the general population with drug efficacy and safety guaranteed associated to low cost.

Reconciling Human-Canine Differences in Oral Bioavailability: Looking beyond the Biopharmaceutics Classification System

2019 ◽  
Vol 21 (5) ◽  
Author(s):  
Marilyn N. Martinez ◽  
Ayman El-Kattan ◽  
Elias Awji ◽  
Mark Papich
Keyword(s):  
Classification System ◽  
Oral Bioavailability ◽  
Biopharmaceutics Classification System ◽  
Biopharmaceutics Classification
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