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Pharmaceutics
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Emerging Strategies in Drug Development and Clinical Care in the...
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Emerging Strategies in Drug Development and Clinical Care in the Era of Personalized and Precision Medicine, 2nd Edition

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Clinical Pharmaceutics".

Deadline for manuscript submissions: 30 June 2025 | Viewed by 4350

Special Issue Editors

Dr. Cristina Manuela Dragoi

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Guest Editor
Department of Biochemistry, Faculty of Pharmacy, Carol Davila University of Medicine and Pharmacy, 020956 Bucharest, Romania
Interests: nutrition; drug design; drugs mechanisms of action; nutrients-drug interactions; precision medicine; biological drugs; chronobiology; pharmacogenomics
Special Issues, Collections and Topics in MDPI journals
Dr. Alina Crenguța Nicolae

E-Mail Website
Guest Editor
Faculty of Pharmacy, University of Medicine and Pharmacy “Carol Davila”, 020956 Bucharest, Romania
Interests: biochemistry; nutrition; drug resistance; P-glycoprotein; neuroscience; clinical research; personalized medicine
Special Issues, Collections and Topics in MDPI journals
Dr. Ion-Bogdan Dumitrescu

E-Mail Website
Guest Editor
Faculty of Pharmacy, University of Medicine and Pharmacy “Carol Davila”, 020956 Bucharest, Romania
Interests: pharmaceutical 3D printing; computer-aided design; clinical pharmacy
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Modern medicine is going through an extremely important moment in its evolution in relation to the disease–drug–patient axis, gradually progressing from pure drug development, which initiates from the need to prevent or treat certain diseases, to the expansion of coherent therapeutic strategies which are personalized for each individual, in recognition of the fact that each patient is a distinct physio-pathological case. Remarkable advances in recent decades in the prevention strategies, diagnostic procedures and available treatments have paved the way to major improvements in patient care. Personalised medicine is approachable if comprehensive details are known about the pathogenesis; the therapeutic agents developed for the management of the pathology in question; the biochemical mechanisms of action of the drugs; the interactions of the drugs with each other and with other endogenous or exogenous factors; and the genetic and epigenetic background of the patient, their chronobiological, nutritional and socio-demographic characteristics.

In this framework, the aim of this Special Issue on “Emerging strategies in drug development and clinical care in the era of personalised and precision medicine” is to unify the most relevant papers addressing the state-of-the-art knowledge and future directions in drug development, therapeutic strategies, and innovative drug formulations, with a focus on biochemical mechanisms of action and drug design, as well as the relevant preclinical and clinical testing of efficacy, pharmacokinetics and toxicity in the era of precision and personalised medicine.

We welcome articles dealing with all aspects of pharmaceutical and medical care, from basic to clinical research, and invite scientists and drug specialists to publish their original research works, review articles, and communications on this wide health domain.

Dr. Cristina Manuela Drăgoi
Dr. Alina Crenguța Crenguţa Nicolae
Dr. Ion-Bogdan Bogdan Dumitrescu
Guest Editors

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.

Keywords

  • drug development
  • therapeutic strategies
  • preclinical and clinical drug research
  • drug design
  • drug–drug interactions
  • clinical care
  • toxicological studies
  • disease risk, disease prognosis and response to therapy
  • biomarkers identification and application
  • biochemistry of drug uptake, action, and metabolism
  • drug target discovery
  • individualized therapy
  • pharmacogenomics
  • novel therapeutics
  • non-drug-related health interferences
  • nutritional interventions
  • chronobiology
  • medicinal chemistry
  • phytochemicals
  • biologics
  • personalized medicine
  • precision medicine

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Published Papers (4 papers)

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Research

12 pages, 440 KiB  
Article
Pharmacogenetics of Neoadjuvant MAP Chemotherapy in Localized Osteosarcoma: A Study Based on Data from the GEIS-33 Protocol
by Juliana Salazar, María J. Arranz, Javier Martin-Broto, Francisco Bautista, Jerónimo Martínez-García, Javier Martínez-Trufero, Yolanda Vidal-Insua, Aizpea Echebarria-Barona, Roberto Díaz-Beveridge, Claudia Valverde, Pablo Luna, María A. Vaz-Salgado, Pilar Blay, Rosa Álvarez and Ana Sebio
Pharmaceutics 2024, 16(12), 1585; https://doi.org/10.3390/pharmaceutics16121585 (registering DOI) - 12 Dec 2024
Viewed by 438
Abstract
Background: Osteosarcoma is a rare disease, but it is the most frequent malignant bone tumor. Primary treatment consists of preoperative MAP (methotrexate (MTX), doxorubicin and cisplatin) chemotherapy followed by surgery and adjuvant chemotherapy. Pathological response to preoperative chemotherapy is one of the most [...] Read more.
Background: Osteosarcoma is a rare disease, but it is the most frequent malignant bone tumor. Primary treatment consists of preoperative MAP (methotrexate (MTX), doxorubicin and cisplatin) chemotherapy followed by surgery and adjuvant chemotherapy. Pathological response to preoperative chemotherapy is one of the most important prognostic factors, but molecular biomarkers are lacking. Additionally, chemotherapy-induced toxicity might jeopardize treatment completion. We evaluated variants in genes involved in DNA repair and drug metabolism pathways as predictors of response to MAP-based treatment. Material and Methods: Germline polymorphisms in MTHFR, SLC19A1, ABCB1, ABCC2, ABCC3, ERCC1, ERCC2 and GSTP1 genes were determined for association studies in 69 patients diagnosed with localized osteosarcoma who enrolled in the prospective GEIS-33 trial. P-glycoprotein expression in tumor tissue was also analyzed. Results: In the multivariate analysis, the ABCC2 rs2273697 (odds ratio [OR] 12.3, 95% CI 2.3–66.2; p = 0.003) and ERCC2 rs1799793 (OR 9.6, 95% CI 2.1–43.2; p = 0.003) variants were associated with poor pathological response. P-glycoprotein expression did not correlate with pathological response. The ABCB1 rs1128503 (OR 11.4, 95% CI 2.2–58.0; p = 0.003) and ABCC3 rs4793665 (OR 12.0, 95% CI 2.1–70.2; p = 0.006) variants were associated with MTX grade 3–4 hepatotoxicity. Conclusions: Our findings add to the evidence that genetic variants in the ABC transporters and DNA-repair genes may serve as predictive biomarkers for MAP chemotherapy and contribute to treatment personalization. Full article
(This article belongs to the Special Issue Emerging Strategies in Drug Development and Clinical Care in the Era of Personalized and Precision Medicine, 2nd Edition)
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17 pages, 4491 KiB  
Article
Computational Analysis of S1PR1 SNPs Reveals Drug Binding Modes Relevant to Multiple Sclerosis Treatment
by Katarina Kores, Samo Lešnik and Urban Bren
Pharmaceutics 2024, 16(11), 1413; https://doi.org/10.3390/pharmaceutics16111413 - 3 Nov 2024
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Abstract
Background/Objectives: Multiple sclerosis (MS) is an autoimmune disorder of the central nervous system (CNS) characterized by myelin and axonal damage with a globally rising incidence. While there is no known cure for MS, various disease-modifying treatments (DMTs) exist, including those targeting Sphingosine-1-Phosphate Receptors [...] Read more.
Background/Objectives: Multiple sclerosis (MS) is an autoimmune disorder of the central nervous system (CNS) characterized by myelin and axonal damage with a globally rising incidence. While there is no known cure for MS, various disease-modifying treatments (DMTs) exist, including those targeting Sphingosine-1-Phosphate Receptors (S1PRs), which play important roles in immune response, CNS function, and cardiovascular regulation. This study focuses on understanding how nonsynonymous single nucleotide polymorphisms (rs1299231517, rs1323297044, rs1223284736, rs1202284551, rs1209378712, rs201200746, and rs1461490142) in the S1PR1’s active site affect the binding of endogenous ligands, as well as different drugs used in MS management. Methods: Extensive molecular dynamics simulations and linear interaction energy (LIE) calculations were employed to predict binding affinities and potentially guide future personalized medicinal therapies. The empirical parameters of the LIE method were optimized using the binding free energies calculated from experimentally determined IC50 values. These optimized parameters were then applied to calculate the binding free energies of S1P to mutated S1PR1, which correlated well with experimental values, confirming their validity for assessing the impact of SNPs on S1PR1 binding affinities. Results: The binding free energies varied from the least favorable −8.2 kcal/mol for the wild type with ozanimod to the most favorable −16.7 kcal/mol for the combination of siponimod with the receptor carrying the F2055.42L mutation. Conclusions: We successfully demonstrated the differences in the binding modes, interactions, and affinities of investigated MS drugs in connection with SNPs in the S1PR1 binding site, resulting in several viable options for personalized therapies depending on the present mutations. Full article
(This article belongs to the Special Issue Emerging Strategies in Drug Development and Clinical Care in the Era of Personalized and Precision Medicine, 2nd Edition)
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14 pages, 321 KiB  
Article
Genetic Variation in CYP2D6, UGT1A4, SLC6A2 and SLCO1B1 Alters the Pharmacokinetics and Safety of Mirabegron
by Paula Soria-Chacartegui, Patricia Cendoya-Ramiro, Eva González-Iglesias, Samuel Martín-Vílchez, Andrea Rodríguez-Lopez, Gina Mejía-Abril, Manuel Román, Sergio Luquero-Bueno, Dolores Ochoa and Francisco Abad-Santos
Pharmaceutics 2024, 16(8), 1077; https://doi.org/10.3390/pharmaceutics16081077 - 17 Aug 2024
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Abstract
Mirabegron is a drug used in overactive bladder (OAB) treatment. Genetic variation in pharmacogenes might alter its pharmacokinetics, affecting its efficacy and safety. This research aimed to analyze the impact of genetic variation on mirabegron pharmacokinetics and safety. Volunteers from three bioequivalence trials [...] Read more.
Mirabegron is a drug used in overactive bladder (OAB) treatment. Genetic variation in pharmacogenes might alter its pharmacokinetics, affecting its efficacy and safety. This research aimed to analyze the impact of genetic variation on mirabegron pharmacokinetics and safety. Volunteers from three bioequivalence trials (n = 79), treated with a single or a multiple dose of mirabegron 50 mg under fed or fasting conditions, were genotyped for 115 variants in pharmacogenes and their phenotypes were inferred. A statistical analysis was performed, searching for associations between genetics, pharmacokinetics and safety. CYP2D6 intermediate metabolizers showed a higher elimination half-life (t1/2) (univariate p-value (puv) = 0.018) and incidence of adverse reactions (ADRs) (puv = 0.008, multivariate p (pmv) = 0.010) than normal plus ultrarapid metabolizers. The UGT1A4 rs2011425 T/G genotype showed a higher t1/2 than the T/T genotype (puv = 0.002, pmv = 0.003). A lower dose/weight corrected area under the curve (AUC/DW) and higher clearance (CL/F) were observed in the SLC6A2 rs12708954 C/C genotype compared to the C/A genotype (puv = 0.015 and 0.016) and ADR incidence was higher when the SLCO1B1 function was decreased (puv = 0.007, pmv = 0.010). The lower elimination and higher ADR incidence when CYP2D6 activity is reduced suggest it might be a useful biomarker in mirabegron treatment. UGT1A4, SLC6A2 and SLCO1B1 might also be involved in mirabegron pharmacokinetics. Full article
(This article belongs to the Special Issue Emerging Strategies in Drug Development and Clinical Care in the Era of Personalized and Precision Medicine, 2nd Edition)
18 pages, 2431 KiB  
Article
Novel Genetic Variants Explaining Severe Adverse Drug Events after Clinical Implementation of DPYD Genotype-Guided Therapy with Fluoropyrimidines: An Observational Study
by Xando Díaz-Villamarín, María Martínez-Pérez, María Teresa Nieto-Sánchez, Gabriela Ruiz-Tueros, Emilio Fernández-Varón, Alicia Torres-García, Beatriz González Astorga, Isabel Blancas, Antonio J. Iáñez, José Cabeza-Barrera and Rocío Morón
Pharmaceutics 2024, 16(7), 956; https://doi.org/10.3390/pharmaceutics16070956 - 19 Jul 2024
Viewed by 1257
Abstract
Fluoropyrimidines (FPs) are commonly prescribed in many cancer streams. The EMA and FDA-approved drug labels for FPs recommend genotyping the DPYD*2A (rs3918290), *13 (rs55886062), *HapB3 (rs56038477), alleles, and DPYD rs67376798 before treatment starts. We implemented the DPYD genotyping in our daily clinical [...] Read more.
Fluoropyrimidines (FPs) are commonly prescribed in many cancer streams. The EMA and FDA-approved drug labels for FPs recommend genotyping the DPYD*2A (rs3918290), *13 (rs55886062), *HapB3 (rs56038477), alleles, and DPYD rs67376798 before treatment starts. We implemented the DPYD genotyping in our daily clinical routine, but we still found patients showing severe adverse drug events (ADEs) to FPs. We studied among these patients the DPYD rs1801265, rs17376848, rs1801159, rs1801160, rs1801158, and rs2297595 as explanatory candidates of the interindividual differences for FP-related toxicities, examining the association with the response to FPs . We also studied the impact of DPYD testing for FP dose tailoring in our clinical practice and characterized the DPYD gene in our population. We found a total acceptance among physicians of therapeutic recommendations translated from the DPYD test, and this dose tailoring does not affect the treatment efficacy. We also found that the DPYD*4 (defined by rs1801158) allele is associated with a higher risk of ADEs (severity grade ≥ 3) in both the univariate (O.R. = 5.66; 95% C.I. = 1.35–23.67; p = 0.014) and multivariate analyses (O.R. = 5.73; 95% C.I. = 1.41–28.77; p = 0.019) among FP-treated patients based on the DPYD genotype. This makes it a candidate variant for implementation in clinical practice. Full article
(This article belongs to the Special Issue Emerging Strategies in Drug Development and Clinical Care in the Era of Personalized and Precision Medicine, 2nd Edition)
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