Biowaiver based on biopharmaceutics classification system: Considerations and requirements [PDF]
Pharmaceutical Science AdvancesBiowaiver allows for the waiver of bioequivalence studies for regulatory approval of certain drug products with saving of time, and money. Before approval of the application for biowaivers, studies based on the Biopharmaceutical Classification System ...
Dr. Smita Kumbhar, Vinod L Gaikwad
exaly +7 more sources
A Physiologically Based Pharmacokinetic Model for Studying the Biowaiver Risk of Biopharmaceutics Classification System Class I Drugs With Rapid Elimination: Dexketoprofen Trometamol Case Study [PDF]
Frontiers in Pharmacology, 2022 Biowaiver based on the biopharmaceutics classification system (BCS) has been widely used in the global market for the approval of new generic drug products to avoid unnecessary in vivo bioequivalence (BE) studies.
Xuxiao Ye
exaly +4 more sources
Applied Sciences (Switzerland), 2020 The lists of essential medicines of the World Health Organization (WHO) and Brazil include gliclazide as an alternative to the oral antidiabetic drug of first choice, metformin, in the treatment of type 2 diabetes mellitus because of its pharmacokinetic ...
Bruna de Carvalho Mapa +2 more
exaly +4 more sources
Effect of the Similarity of Formulations and Excipients of Approved Generic Drug Products on In Vivo Bioequivalence for Putative Biopharmaceutics Classification System Class III Drugs [PDF]
Pharmaceutics, 2023 One of the potential essential factors that restricts generic industry from applying the Biopharmaceutics Classification System (BCS) Class III biowaiver is adherence to the stringent formulation criteria for formulation qualitative (Q1) sameness and ...
Ping Ren +8 more
doaj +2 more sources
A survey of regulatory recommendations for waivers of in vivo bioequivalence studies of generic products for certain dosage forms by participating regulators and organisations of the International Pharmaceutical Regulators Programme. Part 2 [PDF]
Journal of Pharmacy & Pharmaceutical SciencesA biowaiver generally refers to the request to waive an in vivo bioequivalence study. A biowaiver may be granted not only based on the Biopharmaceutics Classifications System (BCS) but also for many immediate-release dosage forms based on pre-defined ...
Alfredo García-Arieta +37 more
doaj +2 more sources
Caco-2 Cell Line Standardization with Pharmaceutical Requirements and In Vitro Model Suitability for Permeability Assays [PDF]
Pharmaceutics, 2023 The Caco-2 cell line derived from human colon carcinoma is commonly used to assess the permeability of compounds in in vitro conditions. Due to the significant increase in permeability studies using the Caco-2 cell line in recent years, the need to ...
Marta Kus +2 more
doaj +2 more sources
Risk analysis in bioequivalence and biowaiver decisions [PDF]
Biopharmaceutics and Drug Disposition, 2013 ABSTRACTThis article evaluates the current biowaiver guidance documents published by the FDA, EU and WHO from a risk based perspective. The authors introduce the use of a Failure Mode and Effect Analysis (FMEA) risk calculation tool to show that current regulatory documents implicitly limit the risk for bioinequivalence after granting a biowaiver by ...
Peter Langguth
exaly +4 more sources
Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Meloxicam [PDF]
MoleculesThis monograph evaluates the scientific and regulatory underpinnings for bioequivalence (BE) waiver of immediate-release (IR) solid oral meloxicam formulations, as a surrogate for in vivo pharmacokinetic trials.
Aixin Guan +5 more
doaj +2 more sources
High-Speed Tableting of High Drug-Loaded Tablets Prepared from Fluid-Bed Granulated Isoniazid [PDF]
Pharmaceutics, 2023 The aim of this feasibility study was to investigate the possibility of producing industrial-scale relevant, robust, high drug-loaded (90.9%, w/w) 100 mg dose immediate-release tablets of isoniazid and simultaneously meet the biowaiver requirements. With
Valentyn Mohylyuk, Dace Bandere
doaj +2 more sources
Update on the advances and challenges in bioequivalence testing methods for complex topical generic products [PDF]
Frontiers in PharmacologyMost of the government regulatory agencies, including the United States Food and Drug Administration and the European Medicine Agency, demand that the generic complex topical products prove pharmaceutical and bioequivalence.
Nedaa Alomari, Waleed Alhussaini
doaj +2 more sources