Pharmacokinetics and Pharmacometrics Driving Innovation

A Special Issue of Pharmaceuticals (ISSN 1424-8247) belonging to the section "Pharmacology".

Deadline for manuscript submissions: 25 September 2026 | Viewed by 1072

Editors


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Guest Editor
Institutos de Ciências da Saúde (ICS), Federal University of Mato Grosso, Sinop, Mato Grosso, Brazil
Interests: pharmacokinetics; drug development; ADME; bioanalytical method development and validation

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Guest Editor
Medical and Clinical Affairs Department, Knight Therapeutics, Sao Paulo 04085-001, Brazil
Interests: bioequivalence; bioavailability; pharmacokinetics; IVIVC; dissolution; PBBM; PBBK; biopharmacy
Special Issues, Collections and Topics in MDPI journals

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Guest Editor
Hospital Alemão Oswaldo Cruz, Sao Paulo, Brazil
Interests: bioanalytical method development and validation; pharmacokinetics; systematic review; meta-analysis

Special Issue Information

Dear Colleagues,

Pharmacokinetics (PK) and pharmacometrics (PMx) have long been central in elucidating drug disposition and guiding pharmacotherapy. Their role has expanded from determining concentration–time profiles to shaping drug development, regulatory science, and clinical practice. By quantifying drug disposition and exposure–response relationships, PK and PMx provide critical insights that can be utilized to improve the safety, efficacy, and individualization of therapy.

For this Special Issue of Pharmaceuticals, “Pharmacokinetics and Pharmacometrics Driving Innovation”, we welcome contributions demonstrating how PK and PMx generate new therapeutic opportunities or optimize existing ones.

Submission topics may include, but are not limited to, the following:

  • Regulatory applications with PBPK/PBBM, IVIVC/IVIVR, exposure–response analyses, and case studies on DDIs or food effects;
  • Early in silico, animal, and translational studies, including microdosing, microtracers, and sparse or opportunistic sampling;
  • Dose optimization and individualization through clinical PK, TDM, Bayesian forecasting, pharmacogenomics, and real-world data;
  • Studies in special populations such as pediatrics, pregnancy, obesity, hepatic/renal impairment, and ICU patients, with formulation or delivery implications;
  • Advances in formulation and drug delivery, bioequivalence, BCS/BDDCS tools, predictive dissolution, and bioperformance;
  • Developments in bioanalytical sciences, including LC-MS/MS validation, miniaturization, and analyte stabilization;
  • Exploratory and proof-of-concept studies identifying therapeutic alternatives, optimizing therapies, or proposing translational strategies;
  • Innovative modeling approaches such as PBPK, PK/PD, QSP, and AI/ML when mechanistically anchored.

This Special Issue will highlight the diversity of PK and PMx applications and their impact on innovation in pharmacotherapy.

Dr. Michel L Campos
Dr. Marcelo Gomes Davanço
Dr. Mariana Millan Fachi
Guest Editors

Manuscript Submission Information

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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-anonymized peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceuticals 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.

Keywords

  • pharmacokinetics
  • drug development
  • ADME
  • bioanalytical methods
  • bioequivalence
  • bioavailability
  • IVIVC
  • PBBM
  • PBBK
  • biopharmacy

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Published Papers (1 paper)

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Research

16 pages, 2003 KB  
Article
A Bioequivalence Study Comparing Two Pomalidomide Hard Capsule Formulations in Healthy Chilean Subjects
by Marcelo Gomes Davanço, Thaís Pereira Vespasiano, Jessé Moisan, Oscar Gonzalez, Milesa Sarmiento and Mélanie Groleau
Pharmaceuticals 2026, 19(7), 1089; https://doi.org/10.3390/ph19071089 - 15 Jul 2026
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Abstract
Background: Multiple myeloma (MM) is a mature B-cell disorder characterized by the excessive production of monoclonal immunoglobulins. It is the second most common hematological cancer and predominantly affects older adults. In 2022, there were approximately 188,000 MM new cases worldwide. The disease is [...] Read more.
Background: Multiple myeloma (MM) is a mature B-cell disorder characterized by the excessive production of monoclonal immunoglobulins. It is the second most common hematological cancer and predominantly affects older adults. In 2022, there were approximately 188,000 MM new cases worldwide. The disease is associated with a relapsing–refractory course. First-line therapies are often insufficient, making additional treatment options necessary. For patients refractory to lenalidomide and proteasome inhibitors (bortezomib and/or carfilzomib), pomalidomide combined with dexamethasone and an additional active agent can be used as a therapeutic strategy. Objective: This study was conducted to evaluate the bioequivalence and tolerability of two pomalidomide hard capsule formulations to support regulatory approval of a branded generic product in Latin American countries. Methods: An open-label, randomized, single-dose, two-treatment, two-sequence, two-period crossover study was conducted in healthy male subjects. Participants received a single oral dose of the test product, Xetrane® 4 mg hard capsule (Laboratório LKM S.A., Argentina), and the reference product, Imnovid® 4 mg hard capsule (Celgene International Sàrl), with a 7-day washout period. Blood samples were collected over 48 h post-dose. Plasma pomalidomide concentrations were determined using a validated LC-MS/MS method, and pharmacokinetic parameters were estimated using non-compartmental analysis. Findings: Thirty-four subjects were enrolled, and 29 completed the study. Geometric mean ratios (90% confidence intervals) for Cmax and AUC0–t were 106.24% (100.77–112.00) and 94.67% (91.61–97.82), respectively. Both formulations were well tolerated. Bioequivalence between Xetrane® and Imnovid® was demonstrated in accordance with regulatory criteria. NCT07694011. Full article
(This article belongs to the Special Issue Pharmacokinetics and Pharmacometrics Driving Innovation)
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