Special Issue "Drug Product Performance: Bioavailability, Relative Bioavailability and Bioequivalence"
Deadline for manuscript submissions: closed (31 July 2023) | Viewed by 4392
Interests: bioavailability; bioequivalence; physiological-based biopharmaceutical models; population pharmacokinetics; modelling and simulation; artificial intelligence
Systemic absorption is often incomplete when given extravascularly. This may be due to formulation issues, drug’s physicochemical characteristics influencing solubilization and membrane permeability, affinity to carrier-mediated transport systems, and chemical and metabolic stability, just to name a few. Knowing the extent of absorption, in a Bioavailability study, is fundamental to define the correct extravascular dose. Comparing the fraction absorbed from different extravascular dosage forms or routes, in a relative bioavailability study, is an alternative approach when intravenous data are not available. Finally, ensuring a similar rate and extent of absorption in Bioequivalence testing is a way to extrapolate the therapeutic outcome between two pharmaceutical drug products. In the past, most of these issues were assessed by in vivo studies, mostly after single dose administration, comparing pharmacokinetic exposure parameters (Cmax and AUC). More complex drug products are, nowadays, requiring additional attention and more complex clinical designs. Further, more and more, additional computational tools are available, such as physiologically based biopharmaceutical models or population pharmacokinetic approaches, frequently connected to in vitro–in vivo correlations that may foster drug discovery and development.
In this Special Issue on Drug Product Performance, we will focus on new tools and approaches for establishing systemic bioavailability and bioequivalence, and will include in silico, in vitro and in vivo methods. We invite researchers, drug developers and regulators to submit their original research or review articles with expert opinions and perspectives in this area.
Dr. Paulo Paixão
Manuscript Submission Information
Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.
Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceutics is an international peer-reviewed open access monthly journal published by MDPI.
Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.
- relative bioavailability
- statistical issues
- regulatory issues
- in vitro–in vivo correlations
- physiologically based biopharmaceutical models
- physiologically based pharmacokinetic models
- qualification of models
- population pharmacokinetic models
- biopharmaceutical classification system
- in vitro dissolution
- dissolution metrics
- predictive dissolution
- clinical trial simulations
- clinical trial optimization
- healthy subjects in BA/BE trials
- patients in BA/BE trials
- pharmacokinetic parameters for BA/BE assessment
- narrow therapeutic index drugs
- highly variable drug products
- immediate-release formulations
- modified-release formulations
- multiphasic drug products
- extravascular routes of administration