Biomedical Data Science & Mathematical Modeling

Vangelis D. Karalis

Professor Department of Pharmacy, National and Kapodistrian University of Athens

Scientifc research

Profile

Professor Vangelis D. Karalis works at the intersection of biomedical sciences, artificial intelligence, data science, and mathematical modeling, with applications in clinical research, pharmacometrics, and computational medicine. His interdisciplinary research integrates quantitative, computational, and clinical approaches to advance modern healthcare, pharmaceutical sciences, and fundamental scientific understanding.

National and Kapodistrian University of Athens

Department of Pharmacy, National and Kapodistrian University of Athens, University Campus, 15784 Athens, Greece.

IACM / FORTH

Computational Pharmacology group, Institute of Applied and Computational Mathematics (IACM), Foundation for Research and Technology Hellas (FORTH), Heraklion, Crete.

Research Theme

Data science and mathematical modeling in pharmaceutical and medical sciences.

Students

Students

Recommendation Letter Prerequisites

  1. Marks higher than 8.0 in Statistics, Introduction into Clinical Pharmacy, and Pharmaceutical care.
  2. Thesis supervision.

Academic Integrity

For reasons of academic integrity, recommendation letters will be sent directly to the recipient.

Research

Scientific Research

Publications are organized into three sections according to their scope, contribution, and publication venue.

Concept-Introducing Research

Articles that introduce new scientific concepts, frameworks, models, or methodological directions.

Vector-based Comparison (VBC)

VBC is an alternative framework for considering endpoints in clinical studies. It treats endpoints as vectors in an N-dimensional space.

  1. Karalis V. A Vector Theory of Assessing Clinical Trials: An Application to Bioequivalence. J Cardiovasc Dev Dis [2024]. doi: 10.3390/jcdd11070185. Seminal article
  2. Kokkali M, Karalis V. Vector-Based Comparison and Average Slope Can Refine Bioequivalence Claims: A Machine and Deep Learning Approach. Biopharm Drug Disp [2026]. doi: 10.1002/bdd.70023
  3. Kokkali M, Karalis V. Vector-based Comparison as a Novel Framework for Assessing Multi-endpoint Clinical Trials: Applications to Actual Data. Clinical and Translational Discovery [2026]. doi: 10.1002/ctd2.70180

AI-generated subjects in clinical studies

The use of generative artificial neural networks, including Normalizing Flow, WGANs, and VAEs, for synthesizing virtual subjects, thereby reducing the need for actual human exposure and reducing time and costs.

  1. Papadopoulos D, Karalis V. Variational Autoencoders for Data Augmentation in Clinical Studies. Applied Sci [2023]. doi.org/10.3390/app13158793. Seminal article
  2. Papadopoulos D, Karalis V. Introducing an Artificial Neural Network for Virtually Increasing the Sample Size of Bioequivalence Studies. Applied Sci [2024]. doi.org/10.3390/app14072970
  3. Nikolopoulos A, Karalis V. Implementation of a Generative AI algorithm for Virtually Increasing the Sample Size of Clinical Studies. Applied Sciences [2024]. doi.org/10.3390/app14114570.
  4. Papadopoulos D, Karali G, Karalis V. Bioequivalence Studies of Highly Variable Drugs: An Old Problem Addressed by Artificial Neural Networks. Applied Sciences [2024]. doi.org/10.3390/app14125279.
  5. Nikolopoulos A, Karalis V. Artificial Intelligence Meets Bioequivalence: Using Generative Adversarial Networks for Smarter, Smaller Trials. Machine Learning and Knowledge Extraction [2025]. https://doi.org/10.3390/make7020047.
  6. Nikolopoulos A, Karalis V. Generative Neural Networks for Addressing the Bioequivalence of Highly Variable Drugs. Algorithms [2025]. https://doi.org/10.3390/a18050266
  7. Nikolopoulos A, Karalis V. The Use of Generative AI to Create Hybrid Populations for Bioequivalence Trials. Applied Math Stat [2026]. https://doi.org/10.53941/ams.2026.100003
  8. Papavramidou N, Karalis V. Generative Data Augmentation in Clinical Studies: A Normalizing Flow Framework with an Inferential Bias-Variance Perspective. Applied Sciences [2026]. https://doi.org/10.3390/app16104692

Average Slope (AS)

AS is a new pharmacokinetic parameter proposed to express more appropriately the rate of absorption and replace Cmax. AS is calculated directly from the concentration-time data without any assumptions.

  1. Karalis V. On the Interplay between Machine Learning, Population Pharmacokinetics, and Bioequivalence to Introduce Average Slope as a New Measure for Absorption Rate. Applied Sci [2023]. doi.org/10.3390/app13042257. Seminal article
  2. Karalis V. An In-Silico Approach Toward the Appropriate Absorption Rate Metric in Bioequivalence. Pharmaceuticals [2023]. doi: 10.3390/ph16050725.
  3. Kokkali M, Karalis V. Average Slope vs. Cmax: Which Truly Reflects the Drug Absorption Rate? Applied Sciences [2024]. doi.org/10.3390/app14146115.

Machine learning in bioequivalence

This research direction introduces the use of machine learning approaches in bioequivalence studies.

  1. Karalis V. Machine Learning in Bioequivalence: Towards Identifying an Appropriate Measure of Absorption Rate. Applied Sci [2023]. doi.org/10.3390/app13010418. Seminal article

In Vitro - In Vivo Simulations (IVIVS)

IVIVS introduces a semi-physiological modeling approach proposed to predict the outcome of a bioequivalence study based on in vitro dissolution data.

  1. Vlachou M, Karalis V. An In Vitro - In Vivo Simulation Approach for the Prediction of Bioequivalence. Materials 14(3):555 [2021]. DOI: 10.3390/ma14030555 Seminal article

Conventional Articles

Applied and methodological research articles in pharmacometrics, pharmacokinetics, and bioequivalence.

  1. Nikolopoulos A, Karalis V. Implementation of Generative AI in Biomedical Research and Healthcare. Applied Biosciences [2026] https://doi.org/10.3390/applbiosci5020034
  2. Tsyplakova A, Catic-Djorđevic A, Stefanović N, Karalis V. Optimizing Mycophenolate Therapy in Renal Transplant Patients Using Machine Learning and Population Pharmacokinetic Modeling. Medical Sciences [2025] https://doi.org/10.3390 /medsci13040235
  3. Tsyplakova N, Ismailos G, Karalis V. Optimising Pirfenidone Dosage Regimens in Idiopathic Pulmonary Fibrosis: Toward a Guide for Personalised Treatment. Xenobiotica [2025]. doi: 10.1080/00498254.2025.2450440.
  4. Gkagkari P, Tagka A, Stratigos A, Karalis V, Kyritsi A, Vitsos A, Rallis MC. Differential Diagnosis of Irritant Versus Allergic Contact Dermatitis Based on Noninvasive Methods. Dermatol. Pract. Concept [2024]. doi: 10.5826/dpc.1404a231.
  5. Kyritsi Α, Tagka Α, Stratigos Α, Karalis V. Preservative Contact Allergy in Occupational Dermatitis: A Machine Learning Analysis. Arch Dermatol Res [2024]. doi: 10.1007/s00403-024-03101-1.
  6. Kyritsi Α, Tagka Α, Stratigos Α, Karalis V. Machine Learning in Allergic Contact Dermatitis: Identifying (Dis)similarities between Polysensitized and Monosensitized Patients. BioMedInformatics [2024]. doi.org/10.3390/biomedinformatics4020074.
  7. Giakoumaki M, … / … Karalis V, Ralis M, Black H. Type I diabetes mellitus suppresses experimental skin carcinogenesis. Cancers [2024]. doi: 10.3390/cancers16081507.
  8. Karalis V. The Integration of Artificial Intelligence into Clinical Practice. Applied Biosciences [2024]. doi.org/10.3390/applbiosci3010002. [Promoted for the Journal Title Story / Journal LinkedIn promoted]
  9. Gkousiaki M, Karalis V, Kyritsi K, Almpani C, Geronikolou S, Stratigos A, Rallis MC, Tagka A. Contact Allergy Caused by Acrylates in Nail Cosmetics: A Pilot Study from Greece. Contact Dermatitis [2024] doi.org/10.1111/cod.14485.
  10. Stratidakis N, Tagka A …/… Karalis V, Dallas P, Stratigos A, Rallis M. Octenidine versus dispase gels for wound healing after cryosurgery treatment in patients with basal cell carcinoma. Adv Exp Med Biol [2023]. doi: 10.1007/978-3-031-31986-0_57.
  11. Daousani C, Karalis V, Loukas Y, Schulpis K, Alexiou K, Dotsikas Y. Dried Blood Spots in Neonatal Studies: A Computational Analysis for the Role of the Hematocrit Effect. Pharmaceuticals [2023]. doi: 10.3390/ph16081126.
  12. Kyritsi A, Tagka A. Stratigos A, Pesli M, Lagiokapa T, Karalis V. A retrospective analysis to investigate contact sensitization in Greek population using classic and machine learning techniques. Adv Exp Med Biol [2023]. doi: 10.1007/978-3-031-31982-2_15.
  13. Damnjanović I, Tsyplakova N, Stefanović N, Tošić T, Catić-Đorđević A, Karalis V. Joint Use of Population Pharmacokinetics and Machine Learning for Optimizing Antiepileptic Treatment in Pediatric Population. Ther Adv Drug Saf [2023]. doi: 10.1177/20420986231181337. [Editor’s in Chief among the 4 Top Articles for 2023].
  14. Matsota P, Karalis V, Saranteas T, Kiospe F, Markantonis SL. Ropivacaine pharmacokinetics in the arterial and venous pools after ultrasound-guided continuous thoracic paravertebral nerve block. J Anaesth Clin Pharmacol [2022]. doi: 10.4103/joacp.joacp_353_22.
  15. Kousovista R, Karali G, Karalis V. Modeling the Double Peak Phenomenon in Drug Absorption Kinetics: The Case of Amisulpride. BioMedInformatics [2023]. doi.org/10.3390/biomedinformatics3010013.
  16. Paschou S, Karalis V, Psaltopoulou T … / … Terpos E, Dimopoulos MA. COVID-19 BNT162b2 mRNA vaccine for patients with type 2 diabetes mellitus. Hormones (2022). doi: 10.1007/s42000-022-00419-1.
  17. Paschou S, Karalis V, Psaltopoulou T … / … Terpos E, Dimopoulos MA. Patients with type 2 diabetes mellitus present similar immunological response to COVID-19 BNT162b2 mRNA vaccine with healthy subjects: a prospective cohort study. Hormones (2022). doi: 10.1007/s42000-022-00405-7.
  18. Kikionis S, … Karalis V, Rallis M, Ioannou E, Roussis V. Ulvan-Based Nanofibrous Patches Enhance Wound Healing of Skin Trauma Resulting from Cryosurgical Treatment of Keloids. Marine Drugs (2022). doi: 10.3390/md20090551.
  19. Terpos E, Fotiou D, Karalis V, … / … Dimopoulos MA. SARS-CoV-2 humoral responses following booster BNT162b2 vaccination in patients with B-cell malignancies. Am J Hematol (2022). doi: 10.1002/ajh.26669.
  20. Ntanasis-Stathopoulos I, Karalis V, …/… Dimopoulos MA, Terpos E. Second booster BNT162b2 restores SARS-CoV-2 humoral response in patients with multiple myeloma, excluding those under anti-BCMA therapy. HemaSphere (2022). doi: 10.1097/HS9.0000000000000764.
  21. Naoum G, Markantonis SL … / Karalis V. On the association between gastrointestinal symptoms and extragastric manifestations. Gastroenterology Research and Practice (2022). doi: 10.1155/2022/8379579.
  22. Ntanasis-Stathopoulos I, Karalis V, …/… Dimopoulos MA, Terpos E. Third dose of the BNT162b2 vaccine results in sustained high levels of neutralizing antibodies against SARS-CoV-2 at 6 months following vaccination in healthy individuals. HemaSphere (2022). doi: 10.1097/HS9.0000000000000747.
  23. Paschou S, Karalis V, … / … Dimopoulos M.A. Patients with autoimmune thyroiditis present similar immunological response to COVID-19 BNT162b2 mRNA vaccine with healthy subjects, while vaccination may affect thyroid function: a clinical study. Frontiers Endocrinol (2022). doi: 10.3389/fendo.2022.840668.
  24. Terpos E, Karalis V, … / … Dimopoulos M.A. Comparison of Neutralizing Antibody Responses at 6 Months Post Vaccination with BNT162b2 and AZD1222. Biomedicines (2022]. doi: 10.3390/biomedicines10020338.
  25. Markantonis SL, Markou N, … / … Karalis V. The pharmacokinetics of levetiracetam in critically ill adult patients: an intensive care unit clinical study. Applied Sci [2022]. doi.org/10.3390/app12031208.
  26. Papadopoulos D … / … Dimopoulos M.A., Karalis V*, Terpos E*. Predictive factors for neutralizing antibody levels nine months after full vaccination with BNT162b2: results of a machine learning analysis. Biomedicines (2022). doi: 10.3390/biomedicines10020204. [* equal last authors]
  27. Terpos E., Karalis V, Sklirou A … / … Dimopoulos MA. Third Dose of the BNT162b2 Vaccine Results in Very High Levels of Neutralizing Antibodies Against SARS-CoV-2; Results of a Prospective Study in 150 Health Professionals in Greece. Am J Hematol (2022) doi: 10.1002/ajh.26468.
  28. Terpos E., Karalis V, Ntanasis-Stathopoulos I …/ …Dimopoulos MA. Sustained but declining humoral immunity against SARS-CoV-2 at 9 months post vaccination with BNT162b2: a prospective evaluation in 309 healthy individuals. HemaSphere (2021). doi: 10.1097/HS9.0000000000000677.
  29. Kousovista R, Karali G, Vlasopoulou K, Karalis V. Validation of population pharmacokinetic models: a comparison of internal and external validation approaches for hydrochlorothiazide. Xenobiotica 9:1-17 (2021). doi: 10.1080/00498254.2021.2012727.
  30. Konstantinidou S, Argyrakopoulou G, Tentolouris N, Karalis V, Kokkinos A. Interplay between baroreflex sensitivity, obesity and related cardiometabolic risk factors. Exp Ther Med (2021). doi: 10.3892/etm.2021.10990.
  31. Rosati M, Terpos E, Agarwal M, Karalis V, … / … Felber B. Distinct Neutralization Profile of Spike Variants by Antibodies Induced upon SARS-CoV-2 Infection or Vaccination. Am J Hematol (2021). doi: 10.1002/ajh.26380.
  32. Terpos E, Karalis V, … / …Trougakos I, Dimopoulos MA. Robust neutralizing antibody responses 6 months post vaccination with BNT162b2: a prospective study in 308 healthy individuals. Life (2021). doi: 10.3390/life11101077.
  33. Karalia D, Samidi A, Karalis V, Vlachou M. 3D-printed oral dosage forms: mechanical properties, computational approaches and applications. Pharmaceutics (2021). doi: 10.3390/pharmaceutics13091401.
  34. Terpos Ea, Trougakos Ia, Karalis V …/…Dimopoulos MA. Kinetics of anti-SARS-CoV-2 antibody responses 3 months post complete vaccination with BNT162b2; a prospective study in 283 health workers. Cells 10: 1942 (2021). DOI: 10.3390/cells1008194. [Equal contribution as first authors]
  35. Robinson P, Terkeltaub R, Pillinger M, Shah B, Karalis V, … Nidorf M. Consensus statement regarding the efficacy and safety of long-term low-dose colchicine in gout and cardiovascular disease. Am J Med (2021). doi: 10.1016/j.amjmed.2021.07.025.
  36. Terpos E, Politou M, Ntanasis-Stathopoulos I, Karalis V, Merkouri E, Fotiou D, Gavriatopoulou M, Malandrakis P, Kastritis E, Trougakos I, Dimopoulos MA. High Prevalence of Anti-PF4 Antibodies Following ChAdOx1 nCov-19 (AZD1222) Vaccination Even in the Absence of Thrombotic Events. Vaccines (2021). doi: 10.3390/vaccines9070712.
  37. Kousovista R, Athanasiou C, Liaskonis K, Ivopoulou O, Karalis V. Quantifying the effect of inhospital antimicrobial use on the development of Colistin resistant Acinetobacter Baumannii strains: a time series analysis. Eur J Hosp Pharm (2021). doi: 10.1136/ejhpharm-2020-002606.
  38. Terpos Ea, Trougakos Ia, Karalis V, …/… Dimopoulos MA. Comparison of neutralizing antibody responses against SARS-CoV-2 in healthy volunteers who received the BNT162b2 mRNA or the AZD1222 vaccine: Should the second AZD1222 vaccine dose be given earlier? Am J Hematol (2021) DOI: 10.1002/ajh.26248 [Top downloaded article from Wiley during its first 12 months of publication]
  39. Kyritsi A, Kikionis S, … Karalis V … Roussis V, Rallis M. Management of Acute Radiodermatitis in Non-Melanoma Skin Cancer Patients Using Electrospun Nanofibrous Patches Loaded with Pinus halepensis Bark Extract. Cancers (2021)
  40. Kousovista R, Athanasiou C, Liaskonis K, Ivopoulou O, Ismailos G, Karalis V. Correlation between Acinetobacter baumannii resistance and hospital use of meropenem, cefepime, and ciprofloxacin: Time series analysis and dynamic regression models. Pathogens 10, 480 (2021). doi.org/10.3390/pathogens10040480
  41. Cardozo B, Karatza E, Karalis V. Osteoporosis treatment with risedronate: a population pharmacokinetic model for the description of its absorption and low plasma levels. Osteoporos Int (2021). DOI: 10.1007/s00198-021-05944-0
  42. Karatza E, Ismailos G, Karalis V. Colchicine for the treatment of COVID-19 patients: efficacy, safety, and model informed dosage regimens. Xenobiotica (2021). DOI: 10.1080/00498254.2021.1909782 [Top 10 most cited articles in Xenobiotica]
  43. Karatza E, Karalis V. Investigating the impact of gastric emptying on pharmacokinetic parameters using delay differential equations and principal component analysis. Eur J Drug Metab (2021). DOI: 10.1007/s13318-021-00683-3
  44. Kousovista R, Athanasiou C, Liaskonis K, Ivopoulou O, Karalis V. Association of antibiotic use with the resistance epidemiology of Pseudomonas Aeruginosa in hospital setting: a four-year retrospective time series analysis. Sci Pharm (2021). doi.org/10.3390/scipharm89010013
  45. Kontostathi M, Isou S, … Karalis V, Klamarias L, Dania F, Papaioannou GT, Roussis V, Polychronopoulos E, Anastassopoulou J, Theophanides T, Rallis MC, Black HS. Influence of Omega-3 Fatty Acid-Rich Fish Oils on Hyperlipidemia: Effect of Eel, Sardine, Trout, and Cod Oils on Hyperlipidemic Mice. J Med Food (2021). DOI: 10.1089/jmf.2020.0114
  46. Konstantinidou S, Kostaras P, Anagnostopoulos GE, Markantonis SL, Karalis V, Konstantinidis K. A Retrospective Study on the Evaluation of the Symptoms, Medications, and Improvement of the Quality of Life of Patients Undergoing Robotic Surgery for Gastroesophageal Reflux Disease. Exp Ther Med 21:174 (2021)
  47. Karatza E, Karalis V. Non-linear mixed effects modeling and simulation for exploring variability sources in dissolution curves: a BCS class II case example. J Bioequiv Bioavail 12: 1-6 (2020)
  48. Karatza E, Ismailos G, Marangos M, Karalis V. Optimization of hydroxychloroquine dosing based on COVID-19 patients’ characteristics: a review of the literature and simulations. Xenobiotica 51:127-138 (2021)
  49. Karatza E, Karalis V. Delay differential equations for the description of Irbesartan pharmacokinetics: a population approach to model absorption complexities leading to dual peaks. Eur J Pharm Sci. 153: 105498 (2020)
  50. Karalis V, Ismailos G, Karatza E. Chloroquine dosage regimens in patients with COVID-19: safety risks and optimization using simulations. Safety Science 129: 104842 (2020)
  51. Karatza Ε, Markantonis S, Savvidou Α, Verentzioti Α, Siatouni Α, Alexoudi Α, Gatzonis S, Mavrokefalou E, Karalis V. Pharmacokinetic and Pharmacodynamic modeling of levetiracetam: investigation of factors affecting the clinical outcome. Xenobiotica 24: 1-11 (2020)
  52. Vlachou M, Siamidi A, Goula E, Georgas P, Pippa N, Karalis V, Sentoukas T, Pispas S. Probing the release of the chronobiotic hormone melatonin from hybrid calcium alginate hydrogel beads. Acta Pharm. 70: 527-38 (2020)
  53. Karatza E. Karalis V. Modelling gastric emptying: a pharmacokinetic model simultaneously describing distribution of losartan and its active metabolite EXP-3174. Basic Clin Pharmacol Toxicol 126: 193-202 (2020)
  54. Kotroni E, Simirioti E, Kikionis S, Sfiniadakis I, Siamidi A, Karalis V, Vitsos A, Vlachou M, Ioannou E, Roussis V, Rallis M. In vivo evaluation of the anti-inflammatory activity of electrospun micro/nanofibrous patches loaded with Pinus halepensis bark extract on hairless mice skin. Materials 12: 2596: 1-13 (2019)
  55. Daousani C, Karalis V, Malenovićc A, Dotsikas Y. Hematocrit Effect on Dried Blood Spots in Adults: A Computational Study and Theoretical Considerations. Scand J Clin Lab Invest. 79(5): 325-33 (2019)
  56. Soulele K, Karalis V. Development of a joint population pharmacokinetic model of ezetimibe and its conjugated metabolite. Eur J Pharm Sci. 128: 18-26 (2019)
  57. Georgiou E, Schoina E, Markantonis SL, Karalis V, Athanasopoulos P, Chrysoheris P, Antonakopoulos F, Konstantinidis K. Laparoscopic TEP Inguinal Hernia Repair: Retrospective Study on Prosthetic Materials, Postoperative Management and Quality of Life. Medicine 97(52):e13974 (2018)
  58. Ioannidis K, …, Karalis V, Markantonis S. Do we need to adopt antifungal stewardship programs? Eur J Hosp Pharm. 25:A77-A78 (2018)
  59. Soulele K, Karalis V. On the Population Pharmacokinetics and the Enterohepatic Recirculation of Total Ezetimibe. Xenobiotica. 27: 1-11 (2018)
  60. Soulele K, Macheras P, Karalis V. On the Pharmacokinetics of Two Inhaled Budesonide/Formoterol Combinations in Asthma Patients Using Modeling Approaches. Pulm Pharmacol Ther. 48: 168-78 (2017)
  61. Vlachou M, Siamidi A, Spaneas D, Lentzos D, Ladia P, Anastasiou K, Papanastasiou I, Foscolos AS, Georgiadis MO, Karalis V, Kellici T, Mavromoustakos T. In vitro Controlled Release of two new Tuberculocidal Adamantane Aminoethers from Solid Pharmaceutical Formulations (II). Drug Res. 67(11):653-60 (2017)
  62. Daousani C, Karalis V. Paediatric medicines: regulatory and scientific issues. Drug Res 67: 377-84 (2017)
  63. Soulele K, Macheras P, Karalis V. Pharmacokinetic Analysis of Inhaled Salmeterol in Asthma Patients: Evidence from Two Dry Powder Inhalers. Biopharm Drug Dispos. 38: 407-419 (2017) [Top-20 downloaded article 2017-18]
  64. Vlachou M, Siamidi A, Diamantidi E, Iliopoulou A, Papanastasiou I, Ioannidou V, Kourbeli V, Foscolos AS, Vocatc A, Colec S, Karalis V, Kellici T, Mavromoustakos T. In vitro Controlled Release from Solid Pharmaceutical Formulations of two new Adamantane Aminoethers with Antitubercular Activity (Ι). Drug Res 67: 447-450 (2017)
  65. Gkinou C, Kani C, Souliotis K, Karalis V, Markantonis-Kyroudi S. Generic drugs – Do they offer the same safety and efficacy as originator medicines? Perceptions and attitudes of final year pharmacy students in Greece. Value in Health 19:A347-A766 (2016)
  66. Markantonis SL, Melemeni A, Markidou M, Haikali SI, Karalis V, Fassoulaki A. Ropivacaine, IL-6 and TNF-α plasma levels during intermittent epidural and continuous wound infusion of ropivacaine for analgesia after hysterectomy or myomectomy: An observational study. Pharmacology 98(5-6): 294-8 (2016)
  67. Karalis V. From Bioequivalence to Biosimilarity: The Rise of a Novel Regulatory Framework. Drug Res. 66: 1-6 (2016)
  68. Soulele K, Macheras P, Silvestro L, Rizea Savu S, Karalis V. Population pharmacokinetics of fluticasone propionate/salmeterol using two different dry powder inhalers. Eur J Pharm Sci. 80: 33-42 (2015)
  69. Daousani C, Karalis V. Bioequivalence studies in Europe before and after 2010. Clin Res Regul Affairs. 32: 9-21 (2015) [Invited Review]
  70. Macheras P, Karalis V. A Non-Binary Biopharmaceutical Classification of Drugs: the ΑΒΓ system. Int J Pharm. 464:85-90 (2014)
  71. Karalis V, Macheras P. On the Statistical Model of the Two-Stage Designs in Bioequivalence Assessment. J Pharm Pharmacol. 66(1):48-52 (2014)
  72. Karalis V, Macheras P, Bialer M. Generic Products of Antiepileptic Drugs: A Perspective on Bioequivalence, Bioavailability and Formulation Switches Using Monte Carlo Simulations. CNS Drugs. 28:69-77 (2014
  73. Karalis V. The Role of the Upper Sample Size Limit in Two-Stage Bioequivalence Designs. Int J Pharm. 456:87-94 (2013)
  74. Karalis V, Bialer M, Macheras P. Quantitative Assessment of the Switchability of Generic Products. Eur J Pharm Sci. 50:476-483 (2013
  75. Macheras P, Karalis V, Valsami G. Keeping a critical eye on the science and the regulation of oral drug absorption: A review. J Pharm Sci. 102: 3018-36 (2013)
  76. Karalis V, Macheras P. An insight into the properties of a two-stage design in bioequivalence studies. Pharm Res. 30:1824-35 (2013
  77. Symillides M, Karalis V, Macheras P. Exploring the relationships between scaled bioequivalence limits and within-subject variability. J Pharm Sci. 102:296-301 (2013)
  78. Karalis V, Macheras P. Current approaches of bioequivalence testing. Expert Opin Drug Metab Toxicol. 2012 8:929-42. (Invited Expert Opinion) [Selected as ‘Editor’s Pick’ in August 2012]
  79. Maltezou HC, Drakoulis N, Siahanidou T, Karalis V, Zervaki E, Dotsikas Y, Loukas YL, Theodoridou M. Safety and Pharmacokinetics of Oseltamivir for Prophylaxis of Neonates Exposed to Influenza H1N1. Pediatr Infect Dis J. 31:527-9 (2012)
  80. Karalis V, Symillides M., Macheras P. Bioequivalence of highly variable drugs: a comparison of the newly proposed regulatory approaches by FDA and EMA. Pharm. Res. 29:1066-77 (2012)
  81. Karalis V, Symillides M., Macheras P. On the leveling-off properties of the new bioequivalence limits for highly variable drugs of the EMA guideline. Eur J. Pharm. Sci. 44:497-505 (2011)
  82. Karalis V, Symillides M, Macheras P. Novel methods to assess bioequivalence. Expert Opin Drug Metab Toxicol. 7:79-88 (2011) (Invited Expert Opinion)
  83. Karalis V, Magklara E, Shah V, Macheras P. From Drug Delivery Systems to Drug Release, Dissolution, IVIVC, BCS, BDDCS, Bioequivalence and Biowaivers. Pharm. Res. 27: 2018-2029 (2010
  84. Karalis V, Macheras P. Examining the Role of Metabolites in Bioequivalence Assessment. J. Pharm. Pharmaceut. Sci. 13: 198-217 (2010)
  85. Karalis V, Symillides M, Macheras P. Comparison of the Reference Scaled Bioequivalence Semi-Replicate Method with other Approaches: Focus on Human Exposure to Drugs. Eur. J. Pharm. Sci. 38: 55-63 (2009)
  86. Karalis V, Macheras P, Van Peer A, Shah V. Bioavailability and Bioequivalence: Focus on Physiological Factors and Variability. Pharm. Res. 25: 1956-62 (2008)
  87. Kytariolos J, Karalis V, Macheras P, Symillides M. Novel Scaled bioequivalence limits with levelling-off properties. Pharm. Res. 23:2657-64 (2006)
  88. Karalis V, Macheras P, Symillides M. Geometric mean ratio dependent scaled bioequivalence limits with levelling-off properties. Eur. J. Pharm. Sci. 26: 54-61 (2005)
  89. Karalis V, Symillides M, Macheras P. Novel scaled average bioequivalence limits based on GMR and variability considerations. Pharm. Res. 21: 1933-1942 (2004)
  90. Dokoumetzidis A, Karalis V, Iliadis A, Macheras P. The heterogeneous course of drug transit through the body. Trends Pharmacol. Sci. 25: 140-146 (2004)
  91. Kosmidis K, Karalis V, Argyrakis P, Macheras P. Michaelis-Menten kinetics under spatially constrained conditions: application to mibefradil pharmacokinetics. Biophys. J. 87: 1498-1506 (2004)
  92. Karalis V, Dokoumetzidis A, Macheras P. A physiologically based approach for the estimation of recirculatory parameters. J. Pharmacol. Exp. Ther. 308: 198-205 (2004)
  93. Karalis V, Tsantili-Kakoulidou A, Macheras P. Quantitative structure pharmacokinetic relationships for disposition parameters of cephalosporins. Eur. J. Pharm. Sci. 20: 115-123 (2003)
  94. Karalis V, Macheras P. Pharmacodynamic considerations in bioequivalence assessment: Comparison of novel and existing metrics. Eur. J. Pharm. Sci. 19: 45-56 (2003)
  95. Karalis V, Tsantili-Kakoulidou A, Macheras P. Multivariate statistics of disposition pharmacokinetic parameters for structurally unrelated drugs used in therapeutics. Pharm. Res. 19: 1829-1836 (2002)
  96. Karalis V, Macheras P. Drug disposition viewed in terms of the fractal volume of distribution. Pharm. Res. 19: 697-704 (2002)
  97. Karalis V, Claret L, Iliadis A, Macheras P. Fractal volume of drug distribution: it scales proportionally to body mass. Pharm. Res. 18: 1056-1060 (2001)

Book Chapters & National Journal Articles

  1. Karalis V. Pharmacokinetics and Pharmacodynamics in Hematocrit and Albumin Disorders. In: Baltopoulos G (Ed.): Intensive Care & Emergency Medicine: Medications for IDE & ED. 28th book. Epistimon (2026).
  2. Tsyplakova A, Catic-Ðordevic Aleksandra, Stefanovic Nikola, Karalis VD. Joint Use of Machine Learning and Population Pharmacokinetics to Optimize Mycophenolate Therapy in Renal Transplant Patients. J Am College Clin Pharm, 216. DOI: 10.1002/jac5.70065.
  3. Theofili MI, Karalis V. Artificial Intelligence applications in Nanosystems: Development, Characterization, and Comparison. In: Techniques and Protocols for Evaluating Nanosystems. Eds. N. Pippa, N. Lagopati. Elsevier (accepted, to be published: October 1, 2025).
  4. Karalis V. Pharmacokinetic and Pharmacodynamic Considerations and their Distinct Characteristics in the Intensive Care Unit. In: Baltopoulos G (Ed.): Intensive Care & Emergency Medicine: Medications for IDE & ED. 27th book. Epistimon (2025).
  5. Papacharalambous M, Karalis V. In Silico Clinical Trials for the Optimization of Anticoagulant Therapy. Pharmakeftiki. 37, 1, 42-57 (2025).
  6. Karalis V, Catić-Đorđević A. Artificial Intelligence in Drug Development, Clinical Trials, and Healthcare. Acta Medica Medianae. 10.5633/amm.2025.0110.
  7. Papadaki K, Karalis V. Prolonged intravenous administration of antibiotics. In: Baltopoulos G (Ed.): Intensive Care and Urgent Medicine: Water and electrolytes. 26th book. pg. 956-960. Epistimon (2024).
  8. Karnaki A, Siamidi A, Karalis V, Lagopati N, Pippa N, Vlachou M. Thermo-responsive hydrogels: current status and future perspectives. Bioinspired Technology and Biomechanics - Annual Volume 2024. DOI: 10.5772/intechopen.114986.
  9. Karalis V. Artificial Intelligence in Drug Discovery and Clinical Practice. pp. 215-255. In: From Current to Future Trends in Pharmaceutical Technology. Eds. N. Pippa, M. Chountoulesi, C. Demetzos. Elsevier, Pub. March 1, 2023.
  10. Kyritsi K, Tagka A, Stratigos A, Karalis V. Analysis of Polysensitization and Monosensitization using Classic and Machine Learning Techniques. Free Radic Biol Med. 201 Sup(1), 49-50 (2023).
  11. Ntousi S, Karalis V. SARS-CoV-2 coronavirus: pathogenesis, pharmacotherapy, and treatment with monoclonal antibodies. Pharmakeftiki. 34: 39-67 (2022).
  12. Deligiannopoulou A, Karalis V. Nanobots in Medicine. Physica Medica 104S2 (2022) S1–S66. DOI: 10.1016/S1120-1797(22)03185-4.
  13. Giannouli E, Karalis V. In the pursuit of longevity: anti-aging substances, nanotechnological preparations, and emerging approaches (2022). doi: https://doi.org/10.1101/2022.03.20.22272670 [medRxiv preprint].
  14. Kontogiannis O, Karalis V. On the in vivo kinetics of gene delivery vectors (2022). MedRxiv. https://doi.org/10.1101/2022.02.11.22269834 [medRxiv preprint].
  15. Karatza E, Karalis V, Markantonis-Kyroudi S. Pharmacokinetics in critically ill elder patients. 21st book. pp. 930-943. In: Baltopoulos G, Boutzouka E, Tsigkou E, Katsoulas T (Eds): Intensive Care and Urgent Medicine: Old age and severe illness. Epistimon (2018).
  16. Filippakis A, Karalis V, Karatza E. Mathematical models in cancer chemotherapy. Pharmakeftiki. 30: 45-63 (2018).
  17. Karalis V. Modeling and Simulation in Bioequivalence. pp. 227-255, Chapter 10. In: Modeling in Biopharmaceutics, Pharmacokinetics and Pharmacodynamics. Homogeneous and Heterogeneous Approaches. 2nd Edition, Springer International Publishing, Switzerland (2016).
  18. Doulou K, Karalis V, Markantonis-Kyroudi S, Petropoulos F, Zafiris E, Naoum G. A retrospective study aiming at correlating non-gastrointestinal symptoms with disorders of the digestive tract. Pharmakeftiki 30(1): 31-43 (2018).
  19. Gavriil ES, Karalis V, Andreadou I. Clopidogrel: Factors that affect its action. Pharmakeftiki. 25: 1-15 (2013).
  20. Karalis V, Markantonis-Kyroudis S. Gender Related Effects on Pharmacokinetics. Pharmakeftiki. 20 (2): 68-81 (2007).
  21. Karalis V, Markantonis-Kyroudis S. Effects of Food on Pharmacokinetics. Pharmakeftiki. 20 (1): 21-34 (2007).
  22. Karalis V, Macheras P. Metrics for the Assessment of Bioequivalence. Pharmakeftiki. 15: 37-44 (2002).

Contact

Contact and addresses

Mailing Address

Department
Department of Pharmacy, National and Kapodistrian University of Athens
Address
University Campus, 15784 Athens, Greece

Office

Phone
+30 210 72724267
Email
vkaralis[at]pharm[dot]uoa[dot]gr