International journal of clinical pharmacology and therapeutics最新文献

{"title":"Bioequivalence study of two formulations of teriflunomide tablets in a healthy Chinese population under fasting and fed conditions.","authors":"Xiaomin Sun, Ronghua Zhu, Jinmiao Lu, Jingjing Li, Juping Ding, Qiang Yu, Xiao Fan, Xiding Yan, Qiangyong Yan, Lingfeng Yang, Pingfei Fang","doi":"10.5414/CP204734","DOIUrl":"https://doi.org/10.5414/CP204734","url":null,"abstract":"<p><strong>Aims: </strong>The aims of this study were to evaluate and compare the pharmacokinetic profiles and establish bioequivalence of test and reference teriflunomide tablets (Aubagio) in healthy Chinese male subjects under fasting and fed conditions.</p><p><strong>Materials and methods: </strong>Subjects were randomly assigned to either the fasting or the fed group and also to one of the two treatment sequences (test-reference or reference-test), according to which they received a single 14-mg dose of the test or reference teriflunomide tablet in the study periods. During each period, blood samples were collected at pre-dose and at intervals up to 72 hours after dosing. After 72 hours post dose, an accelerated elimination procedure using cholestyramine 4 g t.i.d. PO was done. Plasma concentrations of teriflunomide were determined by liquid chromatography-tandem mass spectrometry. The safety of both tablets was monitored throughout the study.</p><p><strong>Results: </strong>48 subjects were enrolled, and all completed the study, with 24 participants each in the fasting and fed groups. In both groups, the 90% confidence intervals for AUC_0-72h and C_max were within the acceptable bioequivalence range (80 - 125%). There were no significant differences in adverse event (AE) reporting between the subjects receiving test or reference tablet. No serious AEs occurred during the study period.</p><p><strong>Conclusion: </strong>The test teriflunomide tablet was pharmacokinetic bioequivalent to the reference teriflunomide tablet (Aubagio) in healthy Chinese male subjects under both fasting and fed conditions. Both formulations were well tolerated by all study participants.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752674","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":"Network pharmacology of ginsenoside Rg3 in the treatment of ovarian cancer: Mechanism of action and experimental verification.","authors":"Yibo Zhu, Xizi Lu, Xiaofeng Ding, Lujia Zhu, Guishu Zeng, Boyu Ren, Yi Yun, Xiang Li, Liliang Wei","doi":"10.5414/CP204674","DOIUrl":"10.5414/CP204674","url":null,"abstract":"<p><strong>Objective: </strong>The aim of this study was to investigate the mechanism of action of ginsenoside Rg3 (Rg3) in the treatment of ovarian cancer (OC).</p><p><strong>Materials and methods: </strong>We used a network pharmacology approach to identify overlapping targets of OC- and Rg3-related genes. The overlapping targets were used for enrichment analysis to construct protein-protein interaction (PPI) networks and identify hub genes. Significantly enriched pathways were validated using in vitro experiments.</p><p><strong>Results: </strong>After identifying the relevant targets of OC and Rg3, 53 overlapping targets were identified. Enrichment analysis revealed that the PI3K-Akt, Ras, Rap1 pathways were significantly enriched. Ten hub genes (<i>AKT1</i>, <i>MMP9</i>, <i>STAT3</i>, <i>JUN</i>, <i>MMP2</i>, <i>EGFR</i>, <i>FGF2</i>, <i>PPARG</i>, <i>KDR</i>, and <i>HSP90AA1</i>) were identified in the PPI network. In vitro experiments revealed that Rg3 exerted therapeutic effects by promoting the apoptosis of OC cells and inhibiting the PI3K-Akt signaling pathway.</p><p><strong>Conclusion: </strong>The combination of network pharmacology and in vitro experimental validation revealed that Rg3 may play a therapeutic role in the treatment of OC by promoting the apoptosis of OC cells via the inhibition of the PI3K-Akt signaling pathway. This provides a new idea for the clinical application of Rg3 in the treatment of OC.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143673836","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":"Advantages of an abdominal anticoagulant subcutaneous injection procedure based on a personal digital assistant and positioning card system: A clinical trial with a historical control cohort.","authors":"Xue-Fen Xia, Zhi-Bo Chen, Chan-Chan Fang, Yu-Jie Xie, Fei-Fan Yan, Sui-Li Yang","doi":"10.5414/CP204754","DOIUrl":"10.5414/CP204754","url":null,"abstract":"<p><strong>Objective: </strong>Our aim in this study is to investigate the advantages of a mobile personal digital assistant (PDA)-based anticoagulant abdominal injection positioning card in the subcutaneous injection process of low molecular weight heparin (LMWH).</p><p><strong>Materials and methods: </strong>This was a historical control study. Convenience sampling was used to include 210 patients diagnosed with venous thromboembolism who received dalteparin sodium (Fragmin) injections in our department between January 2021 and December 2022. Patients were categorized into the control group and the experimental group based on the time period before and after the implementation of the PDA-based anticoagulant abdominal injection positioning card that was developed by the information research and development department of our hospital. The control group consisted of 105 patients treated before the introduction of the PDA-based card (January to December 2021), while the experimental group comprised 105 patients treated after its introduction (January to December 2022). Patients in the control group used subcutaneous injection positioning cards made of paper to determine injection sites, while those in the experimental group used the PDA-based cards to determine injection sites. Outcome measures, including the incidence of subcutaneous bleeding, time spent on the subcutaneous injection procedure, and patient satisfaction, were compared between the two groups.</p><p><strong>Results: </strong>The incidence of subcutaneous bleeding was 5.59% in the experimental group vs. 5.61% in the control group, with no statistically significant difference between the two groups (p > 0.05). The time required for the subcutaneous injection was significantly shorter in the experimental group (63.11 ± 3.59 seconds) than in the control group (83.38 ± 6.96 seconds) (p < 0.05). The patient satisfaction rate was higher in the experimental group (94.3%) than in the control group (80.0%) (p < 0.05).</p><p><strong>Conclusion: </strong>Use of the PDA-based anticoagulant abdominal injection positioning card to determine the abdominal subcutaneous injection site for LMWH does not increase the occurrence of adverse reactions of subcutaneous bleeding, and can ensure the accuracy of medication use and the safety of medication for patients, reduce the time of nursing operations, optimize the nursing process, and improve patient satisfaction.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143673764","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":"Pharmacology and longevity - Network pharmacology: Topics II 2025 and Call-for-Papers.","authors":"Barrington G Woodcock-Kloberdanz","doi":"10.5414/CPP63139","DOIUrl":"https://doi.org/10.5414/CPP63139","url":null,"abstract":"","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143596963","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":"Treatment of delayed fracture healing with Bushen Tiansui decoction: Analysis of active agents and targets using bioinformatics and network pharmacology analysis.","authors":"Gao Wang, Ling Cheng, Zichen Shao, Song Li, Weikang Sun, Jing Liu, Wei Xiong, Huanan Li","doi":"10.5414/CP204705","DOIUrl":"10.5414/CP204705","url":null,"abstract":"<p><strong>Objective: </strong>This study aims to utilize bioinformatics and network pharmacology to identify the active components of Bushen Tiansui decoction (BSTSD) and elucidate its molecular mechanisms and targets in promoting delayed fracture healing.</p><p><strong>Materials and methods: </strong>Using various databases and tools, we identified 155 active compounds within BSTSD's herbal components. Key compounds such as eriodictyol and β-sitosterol were noted for their significant anti-inflammatory, antioxidant, and immunomodulatory effects, which are crucial for promoting fracture healing.</p><p><strong>Results: </strong>Network analysis revealed compounds such as kaempferol and luteolin as having high centrality within the network, indicating their central role in the therapeutic effects of BSTSD. Gene ontology (GO) enrichment analysis highlighted that biological processes such as gland development and aging are vital for fracture healing. Cellular components like membrane rafts and microdomains are essential for maintaining cellular functions and signal transduction during bone repair. Molecular functions such as protein serine/threonine kinase activity play key roles in regulating bone cell proliferation, differentiation, and remodeling. KEGG pathway analysis identified critical pathways including prostate cancer, proteoglycans in cancer, lipid and atherosclerosis, EGFR tyrosine kinase inhibitor resistance, chemical carcinogenesis receptor activation, PI3K-Akt signaling pathway, hepatitis B, endocrine resistance, HIF-1 signaling pathway, and estrogen signaling pathway. Molecular docking results showed strong binding affinities between key compounds and target proteins, supporting the reliability of the network pharmacology predictions.</p><p><strong>Conclusion: </strong>This study provides a comprehensive understanding of the molecular mechanisms by which BSTSD promotes fracture healing, identifying active compounds and pathways that offer scientific bases for the clinical application of BSTSD and paving the way for further experimental validation and therapeutic development.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"114-138"},"PeriodicalIF":0.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142983454","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":"Sodium-glucose cotransporter-2 inhibitor treatment has differential effects on the incidence of various malignancies: Evidence from a spontaneous adverse reaction database.","authors":"Ryo Inose, Yuichi Muraki","doi":"10.5414/CP204645","DOIUrl":"10.5414/CP204645","url":null,"abstract":"<p><strong>Objective: </strong>Sodium-glucose cotransporter (SGLT) 2 inhibitors are expected to demonstrate secondary effects against malignancy. However, long-term and large-scale data are required to evaluate the effects of SGLT2 inhibitors on malignancy, which has not been sufficiently studied in clinical practice. This study aimed to evaluate the association between SGLT2 inhibitors and malignancy using the spontaneous adverse reaction database.</p><p><strong>Materials and methods: </strong>The United States Food and Drug Administration Adverse Event Reporting System database between 1997 (4Q) and 2020 (2Q) was used in this study. Reporting odds ratio (ROR) was selected as the safety-signaling measure. An inverse signal suggesting potential alternative therapeutic opportunities was defined when the upper limit of 95% confidence interval (CI) was < 1. The association between SGLT2 inhibitors and malignancies was evaluated.</p><p><strong>Results: </strong>The total number of reports in the database during the study period was 13,106,455. SGLT2 inhibitors showed significant associations with pancreatic cancer (ROR: 3.08. 95% CI: 2.68 - 3.55), and kidney cancer (ROR: 1.39. 95% CI: 1.13 - 1.72). SGLT2 inhibitors showed significant inverse associations with breast cancer (ROR: 0.32. 95% CI: 0.27 - 0.39), lung cancer (ROR: 0.47. 95% CI: 0.37 - 0.59), liver cancer (ROR: 0.68. 95% CI: 0.50 - 0.93), and malignant melanoma (ROR: 0.49. 95% CI: 0.34 - 0.70).</p><p><strong>Conclusion: </strong>SGLT2 inhibitors may increase the incidence of pancreatic cancer and kidney cancer, and decrease the incidence of breast cancer, lung cancer, liver cancer, and malignant melanoma. These associations need to be further examined in other clinical studies and research in the future.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"98-104"},"PeriodicalIF":0.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143004999","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":"Evidence that anticoagulant use decreases in-hospital deaths in patients with new-onset atrial fibrillation.","authors":"Chun-Tse Hung, Yi-Jei Lin, Chi-Won Suk, Wei-Hsun Shih, Man-Tzu Marcie Wu","doi":"10.5414/CP204686","DOIUrl":"10.5414/CP204686","url":null,"abstract":"<p><strong>Objective: </strong>Current guidelines provide no clear recommendations for managing new-onset atrial fibrillation in critical illness, particularly with respect to anticoagulant use. This retrospective study aimed to evaluate the efficacy and safety of anticoagulants in such patients.</p><p><strong>Materials and methods: </strong>Patients in the intensive care unit with new-onset atrial fibrillation were recruited during the period January 1, 2021, to June 30, 2022. Ischemic stroke and bleeding were considered primary outcomes, and in-hospital death was considered the secondary outcome. Hazard ratios for outcomes were determined using the Cox proportional hazard model.</p><p><strong>Results: </strong>A total of 92 patients were included in the study of which 29 were anticoagulant users and 63 non-users. No significant differences were observed on the risk of ischemic stroke (HR, 3.46; 95% CI, 0.22 - 55.8, p = 0.38) and bleeding (HR, 1.07; 95% CI, 0.52 - 2.23, p = 0.85), but anticoagulant use was associated with a significantly decreased risk of in-hospital death (HR, 0.43; 95% CI, 0.19 - 0.97, p = 0.04).</p><p><strong>Conclusion: </strong>Anticoagulant use in critically ill patients with new-onset atrial fibrillation did not increase the risk of bleeding and ischemic stroke but significantly reduced in-hospital deaths. These findings need confirmation in a randomized controlled trial.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"89-97"},"PeriodicalIF":0.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142948504","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":"Valproic acid-induced hyperammonemia with encephalopathy in adults: A meta-analysis.","authors":"Tsai-Kuei Huang, Yi-Chia Su, Ching-Sen Shih","doi":"10.5414/CP204673","DOIUrl":"10.5414/CP204673","url":null,"abstract":"<p><strong>Objective: </strong>Valproic acid, frequently prescribed for neurological and psychiatric disorders, can cause hyperammonemia (HA). This retrospective study aimed to investigate the association among the basic characteristics, comorbidities, co-medications, and risk of HA in patients receiving valproic acid.</p><p><strong>Materials and methods: </strong>We compared groups with and without HA using data collected from the medical records of adults undergoing valproic acid monitoring between January 1, 2019, and December 31, 2021. We conducted a multivariable logistic regression analysis to explore the risk factors for HA and a comprehensive systematic literature review to identify factors significantly associated with valproic acid-related HA.</p><p><strong>Results: </strong>In total, 247 patients were included, with 37 in the HA group (serum ammonia level > 150 mcg/dL); almost all of them eventually developed hyperammonemic encephalopathy (HE). Multivariable logistic regression analysis revealed that valproic acid levels (odds ratio (OR): 1.01, 95% confidence interval (CI): 0.99 - 1.03), epilepsy (OR: 3.82, 95% CI: 1.52 - 9.62), congestive heart failure (OR: 32.3, 95% CI: 4.09 - 255.4), and concomitant phenytoin use (OR: 6.4, 95% CI: 1.07 - 38.12) are independently associated with HA development during valproic acid therapy. Our data and those of previous studies demonstrate significant associations of valproic acid-related HA with concomitant phenytoin and topiramate use; serum valproic acid concentrations were also significantly positively correlated with serum ammonia levels.</p><p><strong>Conclusion: </strong>The results suggest that serum ammonia and valproic acid levels should be monitored during valproic acid treatment, particularly with concurrent use of phenytoin or topiramate, to prevent further deterioration of HE.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"105-113"},"PeriodicalIF":0.9,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143052420","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":"Warfarin pharmacokinetics and pharmacodynamics are not affected by concomitant administration of the long-acting GLP-1 receptor agonist polyethylene glycol loxenatide.","authors":"Huili Zhou, Guolan Wu, Duo Lv, Meihua Lin, Jianzhong Shentu","doi":"10.5414/CP204510","DOIUrl":"10.5414/CP204510","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate potential drug-drug interactions between polyethylene glycol loxenatide (PEX-168) and warfarin.</p><p><strong>Materials and methods: </strong>This was an open-label, single-arm, two-treatment, sequential study. 16 healthy male subjects were administered warfarin (5 mg) alone on day 1 and received PEX-168 subcutaneously 200 µg once a week during days 14 - 42, with warfarin (5 mg) on day 44. Pharmacokinetics of R- and S-warfarin, as well as pharmacodynamics of warfarin, as measured by prothrombin time (PT) and international normalized ratio (INR), were assessed.</p><p><strong>Results: </strong>The geometric mean ratios (GMRs) of area under the curve from time zero to the time of the last quantifiable concentration (AUC_0-t) for PEX-168 + warfarin vs. warfarin were 0.950 (90% CI: 0.898, 1.006) for R-warfarin and 0.989 (90% CI: 0.946, 1.033) for S-warfarin. The GMRs of maximum observed plasma concentration (C_max) values were 0.965 (90% CI: 0.893, 1.043) for R-warfarin and 0.983 (90% CI: 0.899, 1.075) for S-warfarin, both of which were contained in the interval 0.80 - 1.25. PEX-168 had no effect on the area under the effect-time curve from time 0 to 168 hours of INR and PT, as demonstrated by the GMRs of 0.987 (90% CI: 0.974, 1.000) and 0.990 (90% CI: 0.979, 1.002), respectively.</p><p><strong>Conclusion: </strong>Concomitant administration of PEX-168 and single-dose warfarin was well tolerated. PEX-168 had no effect on the pharmacokinetics or pharmacodynamics of warfarin.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"47-53"},"PeriodicalIF":0.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142739452","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":"Skin adhesion of a newly developed, bioequivalent rotigotine patch formulation in comparison to the originator product: Results of a multi-center, randomized, crossover trial in patients with Parkinson's disease.","authors":"Wolfgang H Jost, Maggie Wang, Gabriel Wauer, Annika Dax, Ralph-Steven Wedemeyer, Barbara Schug, André Warnke, Ana Leblanc, Bjoern Schurad","doi":"10.5414/CP204672","DOIUrl":"10.5414/CP204672","url":null,"abstract":"<p><strong>Objectives: </strong>To demonstrate adequate skin adhesion of a new once-daily rotigotine transdermal patch (ROT-TDS) compared to the originator product (reference) in patients with Parkinson's disease (PD).</p><p><strong>Materials and methods: </strong>Pharmacokinetic bioequivalence (PK BE) was assessed with the 4 mg/24h patches in healthy adults in a single-/multiple-dose, crossover trial. The trial investigating skin adhesion in PD patients (stable dose ≥ 8 mg/day rotigotine) was performed with the 8 mg/24h patches as a multiple-dose, crossover trial (4 alternating once-daily patch applications). Skin status (seborrhea, sweating) was characterized at screening. Adhesion was assessed 5 minutes after application and 5 minutes before removal of each patch. Systemic safety and skin irritation/sensitization were monitored.</p><p><strong>Results: </strong>ROT-TDS was bioequivalent to the reference product in the PK BE trial in 48 randomized healthy subjects. In the skin adhesion trial in 43 randomized PD patients, the cumulative mean percentage of adhesion (90% CI) at the end-of-dosing interval was 92.948% (90.156 - 95.740%) for ROT-TDS and 90.471% (87.574 - 93.367%) for the reference. For ROT-TDS, 80.23% of patches were ≥ 90% adhered at the end-of-dosing interval, while this was the case for 67.44% of the reference patches. Safety and skin tolerability of both products were comparable; the most frequent treatment-related adverse event was application-site pruritus for both treatments at comparable extent.</p><p><strong>Conclusion: </strong>ROT-TDS - with shown BE to the originator reference product - displayed similar safety and local tolerability as the reference product in patients with PD. The results show a trend to improved skin adhesion of the new patch compared to the reference in the target population.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":"77-86"},"PeriodicalIF":0.9,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142380789","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}