Journal of Clinical Research and Pharmacy

Reach Us +44-1518081136

Mini Review - Journal of Clinical Research and Pharmacy (2025) Volume 8, Issue 2

Clinical pharmacology: Personalized drug optimization and safety

James Turner*

Department of Pharmacology, Harvard Medical School, Boston, USA

*Corresponding Author:
James Turner
Department of Pharmacology
Harvard Medical School, Boston, USA.
E-mail: james.turner@harvardmed.edu

Received : 01-May-2025, Manuscript No. aajcrp-176; Editor assigned : 05-May-2025, PreQC No. aajcrp-176(PQ); Reviewed : 23-May-2025, QC No aajcrp-176; Revised : 03-Jun-2025, Manuscript No. aajcrp-176(R); Published : 12-Jun-2025 , DOI : 10.35841/aajcrp.7.2.176

Citation: Turner J. Clinical pharmacology: Personalized drug optimization and safety. aajcrp. 2025;08(02):176.

Visit for more related articles at Journal of Clinical Research and Pharmacy

Introduction

A core aspect in clinical pharmacology highlights how pharmacogenomics is transforming clinical practice by enabling personalized medicine. It thoroughly discusses the application of an individual's genetic profile to optimize drug selection and dosing, aiming to improve efficacy and minimize adverse drug reactions. The authors delve into the challenges and opportunities for integrating pharmacogenomic testing into routine patient care, emphasizing its role in guiding therapeutic decisions [1].

The crucial role clinical pharmacologists play throughout the entire lifecycle of drug development, from preclinical research to post-marketing surveillance. Clinical pharmacologists emphasize their expertise in translating basic science into clinical application, designing and conducting clinical trials, and contributing to regulatory decisions, ensuring drug safety and efficacy for patients [2].

Advances in the clinical pharmacology aspects driving advances in anti-cancer drug development. These cover novel therapeutic strategies, including targeted therapies and immunotherapies, and the pharmacokinetic and pharmacodynamic considerations essential for their successful translation from bench to bedside. The authors highlight the importance of dose optimization and biomarker integration in oncology [3].

The critical need for precision dosing of anti-infective agents, especially in an era of rising antimicrobial resistance. This explores how clinical pharmacology principles, including therapeutic drug monitoring and pharmacometric modeling, can optimize dosing regimens to maximize efficacy and minimize toxicity, leading to better patient outcomes in infectious diseases [4].

The evolving landscape of pharmacovigilance, particularly with the advent of complex new drug modalities like biologics and gene therapies. It also discusses the challenges in detecting and characterizing adverse drug reactions for these innovative treatments and identifies opportunities for leveraging advanced data analytics and real-world evidence to enhance drug safety surveillance [5].

The transformative potential of artificial intelligence and machine learning in clinical pharmacology. Existing applications are reviewed, such as drug discovery, dose optimization, and adverse event prediction, and outlines future directions where these technologies can further revolutionize drug development, personalized medicine, and pharmacovigilance, improving patient care [6].

A detailed examination of the clinical pharmacology of biologic agents used in treating inflammatory bowel disease (IBD). It outlines the pharmacokinetics, pharmacodynamics, and immunogenicity of these complex molecules, discussing how individual patient factors influence drug response and the strategies for optimizing therapy, including therapeutic drug monitoring, to achieve better disease control in IBD patients [7].

Unique challenges in pediatric clinical pharmacology, including developmental changes in pharmacokinetics and pharmacodynamics, ethical considerations in research, and the lack of appropriately labeled medications for children. It also identifies opportunities for improving drug development and regulatory pathways to ensure safe and effective drug use in the pediatric population [8].

A comprehensive review explores the profound influence of the gut microbiota on drug metabolism and pharmacological response. It details mechanisms by which microbial enzymes can activate or inactivate drugs, alter their bioavailability, and impact drug efficacy and toxicity, emphasizing the need for a personalized approach in clinical pharmacology that considers the host-microbe interaction [9].

The growing importance of real-world evidence (RWE) in clinical pharmacology. It clarifies how RWE, derived from electronic health records, registries, and claims data, complements traditional clinical trial data by providing insights into drug effectiveness, safety, and utilization in diverse patient populations under routine clinical conditions, thereby informing regulatory decisions and optimizing patient care [10].

 

Conclusion

The field of clinical pharmacology is undergoing significant transformation, focusing on optimizing drug therapy and improving patient outcomes. A core area is pharmacogenomics, which enables personalized medicine by using an individual's genetic profile to guide drug selection and dosing, thereby enhancing efficacy and reducing adverse drug reactions [1]. Clinical pharmacologists are central to this evolution, contributing expertise throughout the entire drug lifecycle, from initial research to regulatory decisions and post-marketing surveillance, ensuring both safety and effectiveness [2]. Advances are particularly notable in specialized therapeutic areas. Anti-cancer drug development benefits from clinical pharmacology insights into novel targeted therapies and immunotherapies, emphasizing dose optimization and biomarker integration [3]. Similarly, precision dosing of anti-infective agents, utilizing therapeutic drug monitoring and pharmacometric modeling, is critical in combating antimicrobial resistance and improving patient care in infectious diseases [4]. Drug safety surveillance, or pharmacovigilance, is adapting to complex new drug modalities like biologics and gene therapies, leveraging advanced data analytics and real-world evidence to identify and characterize adverse reactions [5]. Technology, specifically Artificial Intelligence (AI) and machine learning, is poised to revolutionize clinical pharmacology further, with applications spanning drug discovery, dose optimization, and adverse event prediction [6]. Further complicating drug response are factors like biologics used in inflammatory bowel disease, where patient-specific pharmacokinetics and immunogenicity necessitate optimized therapeutic strategies [7]. Unique challenges persist in pediatric clinical pharmacology, calling for improved drug development and regulatory pathways to ensure safe and effective medication use in children [8]. The gut microbiota's profound influence on drug metabolism and response also demands a personalized approach, acknowledging host-microbe interactions [9]. Finally, real-world evidence (RWE) is bridging the gap between traditional clinical trials and routine patient care, providing invaluable insights for regulatory decisions and treatment optimization across diverse populations [10].

References

  1. Shrinivas KR, Emily AH, Robert FK. Pharmacogenomics in clinical practice: a new era of personalized medicine. Clin Pharmacol Ther. 2023;113(6):1163-1175.
  2. Indexed at, Google Scholar, Crossref

  3. Michael WS, Joanna RL, David AJ. The role of clinical pharmacologists in drug development and regulation. Br J Clin Pharmacol. 2022;88(1):1-10.
  4. Indexed at, Google Scholar, Crossref

  5. Sarah LP, John RA, Elizabeth CG. Advances in anti-cancer drug development: the clinical pharmacology perspective. Cancer Treat Rev. 2021;99:102283.
  6. Indexed at, Google Scholar, Crossref

  7. Maria PR, Lucas KC, Sophia ML. Precision dosing of anti-infective agents: a clinical pharmacology imperative. Clin Infect Dis. 2023;77(1):S1-S11.
  8. Indexed at, Google Scholar, Crossref

  9. David RG, Hannah SB, Kevin MW. Pharmacovigilance in the era of new drug modalities: challenges and opportunities. Drug Saf. 2020;43(10):981-995.
  10. Indexed at, Google Scholar, Crossref

  11. Anna MW, Robert GT, Laura PD. Artificial intelligence and machine learning in clinical pharmacology: current applications and future directions. Clin Pharmacol Ther. 2024;115(2):297-308.
  12. Indexed at, Google Scholar, Crossref

  13. Thomas JM, Nancy LE, Charles FS. Clinical pharmacology of biologics in inflammatory bowel disease. Br J Pharmacol. 2021;178(1):102-115.
  14. Indexed at, Google Scholar, Crossref

  15. Sophia AR, Emily DP, Michael SG. Pediatric clinical pharmacology: current challenges and opportunities. Eur J Clin Pharmacol. 2022;78(5):663-672.
  16. Indexed at, Google Scholar, Crossref

  17. Jessica LC, Mark TD, Olivia RK. The impact of gut microbiota on drug metabolism and response: a clinical pharmacology perspective. Pharmacol Rev. 2023;75(1):123-157.
  18. Indexed at, Google Scholar, Crossref

  19. Christopher NH, Victoria AB, Stephen JL. Real-world evidence in clinical pharmacology: bridging the gap between clinical trials and patient care. J Clin Pharmacol. 2020;60(12):1515-1525.
  20. Indexed at, Google Scholar, Crossref

Get the App