Anoop Kumar,Manisha Thakur,Mohini Chaurasia,S J S Flora
{"title":"Correlation between essential metals and severe acute respiratory syndrome coronavirus 2 infection.","authors":"Anoop Kumar,Manisha Thakur,Mohini Chaurasia,S J S Flora","doi":"10.4103/ijp.ijp_735_23","DOIUrl":"https://doi.org/10.4103/ijp.ijp_735_23","url":null,"abstract":"","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"21 1","pages":"299-300"},"PeriodicalIF":2.4,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142226424","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Santenna Chenchula,Shubham Atal,Ratinder Jhaj,Chakradhara Rao S Uppugunduri
{"title":"Implementing pharmacogenetic testing to optimize proton-pump inhibitors use among Indian population based on CPIC-CYP2C19-PPI dosing guidelines: The need of the hour.","authors":"Santenna Chenchula,Shubham Atal,Ratinder Jhaj,Chakradhara Rao S Uppugunduri","doi":"10.4103/ijp.ijp_198_24","DOIUrl":"https://doi.org/10.4103/ijp.ijp_198_24","url":null,"abstract":"Proton-pump inhibitors (PPIs) are widely prescribed to decrease stomach acid and treat various acid-related Gastrointestinal tract (GIT) diseases. However, genetic variations, particularly in the CYP2C19 gene, affect PPIs metabolism and efficacy. Variants in CYP2C19 can result in different rates of PPI metabolism, influencing their effectiveness. Personalized medicine strategies, such as genotyping for CYP2C19, have the potential to enhance the effectiveness of PPI therapy and patient safety. This review aims to describe the relevance of CYP2C19 genetic profiling in the indian population, including normal function (e.g. CYP2C19*1, *11, *13, *15, *18, *28, and 38), decreased function (e.g., CYP2C19*9, *10, *16, *19, *25, and 26), loss of function (e.g., CYP2C19*2, *3, *4, *5, *6, *7, *8, *22, *24, *35, *36, and *37), and increased function (e.g., CYP2C19*17) variants. This review also examines the clinical pharmacogenomics implementation consortium (CPIC)-CYP2C19-PPI guidelines to highlight the importance of pharmacogenomics (PGx)-informed personalized PPI therapy for gastroesophageal reflux disease and peptic ulcer disease treatment. On average, each person in India possesses eight pharmacogenetic (PGx) variants that can be clinically significant, underscoring the need for preemptive testing. Implementing CYP2C19 genetic testing in India requires expanding laboratory capacity, increasing accessibility in primary care, increasing public awareness, collaboration between pharmacovigilance and PGx programs, investing in advanced sequencing technologies, data management systems, and integration with electronic health records and clinical decision support systems. Addressing challenges such as genetic diversity, socioeconomic factors, health-care access issues, and shortage of trained professionals is essential for implementation. Due to the lack of definitive country-specific policies and PGx guidelines from Indian drug regulatory agencies, guidelines from international consortia such as the Clinical Pharmacogenetics Implementation Consortium and drug labeling offer crucial foundational evidence. This evidence can be used to enhance patient outcomes and ensure the safe and effective use of PPIs in India.","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"30 1","pages":"277-284"},"PeriodicalIF":2.4,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142226423","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Applying quantitative and systems pharmacology to drug development and beyond: An introduction to clinical pharmacologists","authors":"Mathan Kumar Ramasubbu, Bhairav Paleja, Anand Srinivasann, Rituparna Maiti, Rukmini Kumar","doi":"10.4103/ijp.ijp_644_23","DOIUrl":"https://doi.org/10.4103/ijp.ijp_644_23","url":null,"abstract":"<p>Quantitative and systems pharmacology (QSP) is an innovative and integrative approach combining physiology and pharmacology to accelerate medical research. This review focuses on QSP’s pivotal role in drug development and its broader applications, introducing clinical pharmacologists/researchers to QSP’s quantitative approach and the potential to enhance their practice and decision-making. The history of QSP adoption reveals its impact in diverse areas, including glucose regulation, oncology, autoimmune disease, and HIV treatment. By considering receptor–ligand interactions of various cell types, metabolic pathways, signaling networks, and disease biomarkers simultaneously, QSP provides a holistic understanding of interactions between the human body, diseases, and drugs. Integrating knowledge across multiple time and space scales enhances versatility, enabling insights into personalized responses and general trends. QSP consolidates vast data into robust mathematical models, predicting clinical trial outcomes and optimizing dosing based on preclinical data. QSP operates under a “learn and confirm paradigm,” integrating experimental findings to generate testable hypotheses and refine them through precise experimental designs. An interdisciplinary collaboration involving expertise in pharmacology, biochemistry, genetics, mathematics, and medicine is vital. QSP’s utility in drug development is demonstrated through integration in various stages, predicting drug responses, optimizing dosing, and evaluating combination therapies. Challenges exist in model complexity, communication, and peer review. Standardized workflows and evaluation methods ensure reliability and transparency.</p>","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"65 1","pages":""},"PeriodicalIF":2.4,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142206513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Advancing pediatric drug development in South Asia: Current landscape and vision for the future","authors":"Rajesh Krishna, Manoj Jadhav, Rama Sivasubramanian, Gangadhar Sunkara, Vikram Gota, Vis Niranjan, Vipin Dhote, Nidhi Sapkal, Nirmala N Rege, Samir Sethi, Bikash Medhi, Nilima Kshirsagar, Deven Parmar","doi":"10.4103/ijp.ijp_396_24","DOIUrl":"https://doi.org/10.4103/ijp.ijp_396_24","url":null,"abstract":"<p>The manuscript summarizes the outcomes of a one-day conference by the South Asian College of American College of Clinical Pharmacology (SAC-ACCP) in July 2023, at Bhopal. The theme of the conference was “Advancing pediatric drug development in South Asia.” SAC-ACCP organized this event in Bhopal to foster the discipline of clinical pharmacology and to motivate researchers and physicians in the in the central part of India. The conference featured presentations on regional approaches to pediatric drug development in Asia by pediatric scientific experts from the pharmaceutical industry, regulatory agencies, as well as independent consultancies. The speakers highlighted several important aspects of the evolving regulatory landscape in India and proposed numerous actionable steps in acceleration of pediatric drug development. This commentary provides insights from presentations and the panel discussion at this conference and also makes an attempt to connect to similar discussions that occurred at the SAC-ACCP drug development conference in 2017.</p>","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"9 1","pages":""},"PeriodicalIF":2.4,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142206515","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Anecdotal and experimental observation of putative onco-regressive factors in urine: The need for detailed further investigation.","authors":"Ashok D B Vaidya","doi":"10.4103/ijp.ijp_270_24","DOIUrl":"https://doi.org/10.4103/ijp.ijp_270_24","url":null,"abstract":"","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"5 1","pages":"295-296"},"PeriodicalIF":2.4,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142226422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A novel ultra-performance liquid chromatography detection method development and validation for paclitaxel and its major metabolite in human plasma.","authors":"Vikas Kumar,Gyan Vardhan,Amit Sehrawat,Shailendra Handu,Puneet Dhamija","doi":"10.4103/ijp.ijp_557_23","DOIUrl":"https://doi.org/10.4103/ijp.ijp_557_23","url":null,"abstract":"BACKGROUNDPaclitaxel is a promising anticancer drug for patients with ovarian, breast, lung, gastrointestinal, genitourinary, prostate, and head-and-neck cancers. Paclitaxel follows nonlinear pharmacokinetics. The major metabolite of paclitaxel is 6-alpha-hydroxy paclitaxel, mediated by CYP2C8, while metabolism to two of its minor metabolites, 3'-p-hydroxypaclitaxel and 6a, 3'- p-dihydroxypaclitaxel, is catalyzed by CYP3A4. Therapeutic drug monitoring of paclitaxel could be a promising approach to improve the efficacy and safety of paclitaxel correct personalized doses and improve the overall benefit-risk ratio. A novel and highly sensitive chromatographic method for the detection of paclitaxel and its metabolite has been proposed that allows quantification in human plasma with 100% accuracy in terms of recovery without significant intraday or interday variations.MATERIALS AND METHODSThe present study was planned following bioanalytical method validation guidance according to the U.S. Food and Drug Administration requirements. The validation of the analytical procedure was performed as per ICH Q2(R1) guidelines. It was done to assure the reliability of the results obtained for various parameters such as linearity, accuracy, precision, limit of detection (LOD), limit of quantification, robustness, stability, and system suitability.RESULTSThe specificity of the method was established by ensuring no interference with peak obtained from paclitaxel and 6-alpha-hydroxy paclitaxel. LOD was found to be 0.05 and 0.033 while the limit of quantitation was 0.14 and 0.099 for paclitaxel and 6-alpha-hydroxy paclitaxel, respectively. Median (±interquartile range) accuracy for paclitaxel and 6-alpha-hydroxy paclitaxel was found to be 102.73 (±13.581) and 100.87 (±7.573), respectively.CONCLUSIONThis novel method of simultaneous detection of paclitaxel and its major metabolite 6-alpha-hydroxy paclitaxel demonstrated significant resolution and was sensitive enough for its quantification in human plasma.","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"4 1","pages":"253-259"},"PeriodicalIF":2.4,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142206519","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Can baxdrostat revamp resistant hypertension status in India?","authors":"Elisha Paikray,Satyajit Mohapatra","doi":"10.4103/ijp.ijp_141_24","DOIUrl":"https://doi.org/10.4103/ijp.ijp_141_24","url":null,"abstract":"","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"25 1","pages":"293-294"},"PeriodicalIF":2.4,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142226425","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Prospective, randomized, placebo-controlled, two-arm study to evaluate the efficacy of coadministration of garlic as a hydrogen sulfide donor and tadalafil in patients with erectile dysfunction not responding to tadalafil alone – A pilot study","authors":"Gajanan Shripad Bhat, Anuradha Shastry","doi":"10.4103/ijp.ijp_310_23","DOIUrl":"https://doi.org/10.4103/ijp.ijp_310_23","url":null,"abstract":"<h3>OBJECTIVE: </h3>\u0000<p>The objective is to evaluate the efficacy of coadministration of garlic (as a hydrogen sulfide [H<sub xmlns:mrws=\"http://webservices.ovid.com/mrws/1.0\">2</sub>S] donor) and tadalafil for patients with ED using a placebo-controlled, prospective, randomized, two-arm pilot study in patients responding poorly to tadalafil alone.</p>\u0000<h3>MATERIALS AND METHODS: </h3>\u0000<p>The patients with complaints of ED (with normal penile Doppler) who failed to maintain sustained improvement in erectile function with tadalafil were recruited after excluding those with comorbidities. The study sample was randomized into two groups. Group A received garlic 5 g twice a day orally and Group B received a placebo twice daily orally for 4 weeks. Both groups continued tadalafil 5 mg in the night for 4 weeks. Their erectile function was assessed at the beginning and at the end of 4 weeks using the International Index of Erectile Function (IIEF-EF), erectile function domain and compared. A value of <em xmlns:mrws=\"http://webservices.ovid.com/mrws/1.0\">P</em> ≤ 0.05 was considered statistically significant.</p>\u0000<h3>RESULTS: </h3>\u0000<p>Nineteen patients in Group A (mean age 37.5 ± 10.6 years) and 16 patients in Group B (mean age 39.6 ± 9.6 years) participated in the pilot study conducted from May 2022 to August 2022. The participants treated with garlic (as an H<sub xmlns:mrws=\"http://webservices.ovid.com/mrws/1.0\">2</sub>S donor) as a coadministrant had statistically significant improvement in IIEF-EF score (<em xmlns:mrws=\"http://webservices.ovid.com/mrws/1.0\">P</em> ≤ 0.0001) at the end of 4 weeks compared to placebo.</p>\u0000<h3>CONCLUSIONS: </h3>\u0000<p>Garlic (as an H<sub xmlns:mrws=\"http://webservices.ovid.com/mrws/1.0\">2</sub>S donor) as adjunctive therapy was beneficial in our study participants responding poorly to tadalafil alone.</p>","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"40 1","pages":""},"PeriodicalIF":2.4,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142206514","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}