Emerging Trends in Bioequivalence Research
A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Pharmacokinetics and Pharmacodynamics".
Deadline for manuscript submissions: 20 May 2025 | Viewed by 1404
Special Issue Editors
Interests: bioequivalence; pharmacokinetics; bioavailability; drug product development; IVIVC; biopharmaceutics; PBBM; biowaiver
Interests: pharmacokinetic drug–drug interaction; pharmacokinetic herb–drug interaction; drug-metabolizing enzymes and transporters; pharmacokinetic/pharmacodynamics in drug development; oral bioavailability
Special Issues, Collections and Topics in MDPI journals
Interests: controlled bioavailability of poorly soluble and poorly absorbable drugs; solubilization, formulation, and development of patient-centric dosage forms; advanced nano-based delivery systems using fattigation (fatty acid conjugation) and click chemistry
Special Issues, Collections and Topics in MDPI journals
Special Issue Information
Dear Colleagues,
Bioequivalence (BE) assessment is a crucial way to establish therapeutic equivalence for generic drug products and their respective comparator products. In addition, bioavailability comparison may sometimes also be required for supporting regulatory approval of incremental innovation, such as new dosage forms, fixed-dose combinations, and other approaches. Furthermore, BE studies are used by innovator and generic product developers to support post-approval formulation and/or manufacturing process changes. Two drug products containing the same drug substance(s) are considered bioequivalent if their rate and extent of drug absorption, after administration in the same molar dose, lie within acceptable predefined limits. These limits are set to ensure comparable in vivo performance, i.e., similarity in terms of safety and efficacy.
Current regional or multi-regional guidelines have different views and criteria regarding the design of BE studies and data analysis. The new ICH (International Conference on Harmonisation) M13 initiative is looking to harmonise BE requirements for immediate release solid oral dosage forms, which could facilitate the use of the same data and information to meet multiple jurisdictions’ regulatory requirements and ensures the application of consistent standards for demonstrating BE. Moreover, harmonisation may streamline drug development and make it more cost effective, by potentially reducing the number of duplicative BE studies that are required to meet the standards for more than one jurisdiction and lead to a reduced number of human subjects that are required for these studies.
We are pleased to invite all researchers to submit their findings and recent advances on BE assessment. In this Special Issue, original research articles and reviews are welcome. Topics of interest may include, but are not limited to, BE studies for generics (mainly complex generics, such as inhalers, injectables, ophthalmic solutions and suspensions, and transdermal patches) and incremental innovation (e.g., new dosage forms, fixed-dose combination, etc.), advanced BE study design considerations, data analysis and BE assessment for highly variable drugs and drugs with a narrow therapeutic index, truncated or partial AUC considerations, advances in bioanalysis for endogenous compounds and ligand-binding assays (LBAs), biowaiver approaches based on BCS, and biopredictive dissolution conditions and PBBM/IVIVC models for predicting BE study results.
We look forward to receiving your contributions.
Dr. Marcelo Gomes Davanço
Prof. Dr. Im-Sook Song
Prof. Dr. Beom-Jin Lee
Guest Editors
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Keywords
- bioequivalence
- bioavailability
- pharmacokinetics
- ICH M13
- complex generics
- biowaiver based on BCS
- bioanalysis
- biopredictive dissolution conditions
- PBBM
- IVIVC
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