PMID- 38299552 OWN - NLM STAT- Publisher LR - 20240201 IS - 1744-7607 (Electronic) IS - 1742-5255 (Linking) DP - 2024 Feb 1 TI - In-silico approaches to assessing multiple high-level drug-drug and drug-disease adverse drug effects. PG - 1-14 LID - 10.1080/17425255.2023.2299337 [doi] AB - INTRODUCTION: Pharmacovigilance plays a pivotal role in monitoring adverse events (AEs) related to chemical substances in human/animal populations. With increasing spontaneous-reporting systems, researchers turned to in-silico approaches to efficiently analyze drug safety profiles. Here, we review in-silico methods employed for assessing multiple drug-drug/drug-disease AEs covered by comparative analyses and visualization strategies. AREAS COVERED: Disproportionality, involving multi-stage statistical methodologies and data processing, identifies safety signals among drug-AE pairs. By stratifying data based on disease indications/demographics, researchers address confounders and assess drug safety. Comparative analyses, including clustering techniques and visualization techniques, assess drug similarities, patterns, and trends, calculate correlations, and identify distinct toxicities. Furthermore, we conducted a thorough Scopus search on 'pharmacovigilance,' yielding 5,836 publications spanning 2003 to 2023. EXPERT OPINION: Pharmacovigilance relies on diverse data sources, presenting challenges in the integration of in-silico approaches and requiring compliance with regulations and AI adoption. Systematic use of statistical analyses enables identifications of potential risks with drugs. Frequentist and Bayesian methods are used in disproportionalities, each with its strengths and weaknesses. Integration of pharmacogenomics with pharmacovigilance enables personalized medicine, with AI further enhancing patient engagement. This multidisciplinary approach holds promise, improving drug efficacy and safety, and should be a core mission of One-Health studies. FAU - Xu, Xuan AU - Xu X AD - 1DATA Consortium, www.1DATA.life, Kansas State University Olathe, Olathe, KS, USA. AD - Food Animal Residue Avoidance and Databank Program (FARAD), Kansas State University Olathe, Olathe, KS, USA. AD - Department of Mathematics, Kansas State University, Manhattan, KS, USA. FAU - Riviere, Jim E AU - Riviere JE AD - 1DATA Consortium, www.1DATA.life, Kansas State University Olathe, Olathe, KS, USA. AD - Food Animal Residue Avoidance and Databank Program (FARAD), Kansas State University Olathe, Olathe, KS, USA. FAU - Raza, Shahzad AU - Raza S AD - Taussig Cancer Center, Cleveland Clinic, Cleveland, OH, USA. FAU - Millagaha Gedara, Nuwan Indika AU - Millagaha Gedara NI AD - 1DATA Consortium, www.1DATA.life, Kansas State University Olathe, Olathe, KS, USA. AD - Department of Mathematics, Kansas State University, Manhattan, KS, USA. FAU - Ampadi Ramachandran, Remya AU - Ampadi Ramachandran R AD - 1DATA Consortium, www.1DATA.life, Kansas State University Olathe, Olathe, KS, USA. AD - Food Animal Residue Avoidance and Databank Program (FARAD), Kansas State University Olathe, Olathe, KS, USA. AD - Department of Mathematics, Kansas State University, Manhattan, KS, USA. FAU - Tell, Lisa A AU - Tell LA AD - FARAD, Department of Medicine and Epidemiology, School of Veterinary Medicine, University of California-Davis, Davis, CA, USA. FAU - Wyckoff, Gerald J AU - Wyckoff GJ AD - 1DATA Consortium, www.1DATA.life, Kansas State University Olathe, Olathe, KS, USA. AD - School of Pharmacy, Division of Pharmacology and Pharmaceutical Sciences, University of Missouri-Kansas, Kansas, USA. FAU - Jaberi-Douraki, Majid AU - Jaberi-Douraki M AUID- ORCID: 0000-0002-8505-6550 AD - 1DATA Consortium, www.1DATA.life, Kansas State University Olathe, Olathe, KS, USA. AD - Food Animal Residue Avoidance and Databank Program (FARAD), Kansas State University Olathe, Olathe, KS, USA. AD - Department of Mathematics, Kansas State University, Manhattan, KS, USA. LA - eng PT - Journal Article PT - Review DEP - 20240201 PL - England TA - Expert Opin Drug Metab Toxicol JT - Expert opinion on drug metabolism & toxicology JID - 101228422 SB - IM OTO - NOTNLM OT - Pharmacovigilance OT - adverse effects OT - frequentist and bayesian methods OT - machine learning approach OT - one health EDAT- 2024/02/01 12:44 MHDA- 2024/02/01 12:44 CRDT- 2024/02/01 08:39 PHST- 2024/02/01 12:44 [medline] PHST- 2024/02/01 12:44 [pubmed] PHST- 2024/02/01 08:39 [entrez] AID - 10.1080/17425255.2023.2299337 [doi] PST - aheadofprint SO - Expert Opin Drug Metab Toxicol. 2024 Feb 1:1-14. doi: 10.1080/17425255.2023.2299337.