Drugs in Research & Development最新文献

{"title":"Bioavailability of Oniria^®, a Melatonin Prolonged-Release Formulation, Versus Immediate-Release Melatonin in Healthy Volunteers.","authors":"Manuel Román Martinez, Eva García Aguilar, Samuel Martin Vílchez, Javier González García, Sergio Luquero-Bueno, Paola Camargo-Mamani, Gina Mejia-Abril, Laura García-Castro, Alejandro de Miguel-Cáceres, Paula Saz-Leal, Francisco Abad-Santos, Concepcion Nieto Magro, Dolores Ochoa Mazarro","doi":"10.1007/s40268-022-00394-3","DOIUrl":"10.1007/s40268-022-00394-3","url":null,"abstract":"<p><strong>Background: </strong>Melatonin is an endogenous substance which plays a key role in sleep induction by reducing sleep onset latency; it has been approved by the European Food Safety Authority as a food supplement for exogenous administration. Oniria^® is a food supplement formulated as 1.98 mg of prolonged-release melatonin tablets; it displays a dual dissolution profile in vitro.</p><p><strong>Objectives: </strong>The main objective of the present study was to evaluate the relative oral bioavailability of Oniria^®, in comparison with immediate-release tablets (IRT) with a similar melatonin content as a reference. We also attempted to characterize the circadian rhythm of endogenous melatonin.</p><p><strong>Methods: </strong>We performed an open-label, cross-over, randomized, phase I clinical study with two sequences and three periods involving 14 healthy volunteers. We characterized the endogenous melatonin circadian profile (period 1) and pharmacokinetics (PK) of both Oniria^® and the reference melatonin (periods 2 and 3).</p><p><strong>Results: </strong>Two phases were clearly differentiated in the PK profile of Oniria^®. An initial one, from dosing up to 2 h, and a delayed one from 2 to 11 h post-administration. During the initial phase, both melatonin formulations were equivalent, with a C_max value close to 4000 pg/mL. However, in the delayed phase, Oniria^® showed significantly higher melatonin concentrations than the IRT (three times higher at 4-6 h post-administration). Moreover, Oniria^® exhibited concentrations above the endogenous melatonin peak of 80 pg/mL for up to 2.5 h versus the reference formulation, potentially suggesting an effect of Oniria^®, not only in the induction of sleep, but also in the maintenance.</p><p><strong>Conclusion: </strong>Oniria^® could be a highly promising food supplement, not only for sleep induction but also for the maintenance of sleep.</p>","PeriodicalId":49258,"journal":{"name":"Drugs in Research & Development","volume":"22 3","pages":"235-243"},"PeriodicalIF":2.2,"publicationDate":"2022-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/fa/ef/40268_2022_Article_394.PMC9433621.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40665668","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association between Acid-Suppressive Drugs and Clinical Outcomes in Patients with Nonvalvular Atrial Fibrillation.","authors":"Hideki Arai, Shinichiro Ueda, Kazutaka Uchida, Fumihiro Sakakibara, Norito Kinjo, Mari Nezu, Takeshi Morimoto","doi":"10.1007/s40268-022-00392-5","DOIUrl":"10.1007/s40268-022-00392-5","url":null,"abstract":"<p><strong>Purpose: </strong>Acid-suppressive drugs (ASDs) are often prescribed for patients with nonvalvular atrial fibrillation (NVAF) taking oral anticoagulants (OACs). However, the risk-benefit balance of ASDs prescription for patients with NVAF taking OACs is still unclear. This study aimed to assess the association between ASDs and clinical outcomes in patients taking OACs for NVAF.</p><p><strong>Methods: </strong>This study is a subanalysis of an historical registry study from 71 centers in Japan. We included patients taking vitamin K antagonists for NVAF and excluded those with mechanical heart valves or a history of pulmonary thrombosis or deep vein thrombosis. We registered consecutive patients in February 2013 and followed them up until February 2017. The primary outcomes were ischemic events, major bleedings, and all-cause mortality. Ischemic stroke, acute myocardial infarction, and hemorrhagic stroke comprised the secondary outcomes.</p><p><strong>Results: </strong>We included 7826 patients with a mean age of 73 years, 5274 (67%) of whom were males. The adjusted hazard ratios (95% confidence intervals) for ischemic events, major bleedings, and all-cause mortality in the ASD group compared with the no-ASD group were 0.998 (0.78-1.27), 0.98 (0.81-1.18), and 1.22 (1.02-1.47), respectively, while those for ischemic stroke, acute myocardial infarction, and hemorrhagic stroke were 0.96 (0.74-1.24), 0.82 (0.36-1.88), and 1.17 (0.69-1.99), respectively.</p><p><strong>Conclusions: </strong>ASDs were significantly associated with all-cause mortality in patients with NVAF taking OACs.</p>","PeriodicalId":49258,"journal":{"name":"Drugs in Research & Development","volume":"22 3","pages":"213-222"},"PeriodicalIF":2.2,"publicationDate":"2022-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/65/f1/40268_2022_Article_392.PMC9433614.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40605408","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Association between Acid-Suppressive Drugs and Clinical Outcomes in Patients with Nonvalvular Atrial Fibrillation.","authors":"Hideki Arai,&nbsp;Shinichiro Ueda,&nbsp;Kazutaka Uchida,&nbsp;Fumihiro Sakakibara,&nbsp;Norito Kinjo,&nbsp;Mari Nezu,&nbsp;Takeshi Morimoto","doi":"10.1007/s40268-022-00401-7","DOIUrl":"https://doi.org/10.1007/s40268-022-00401-7","url":null,"abstract":"","PeriodicalId":49258,"journal":{"name":"Drugs in Research & Development","volume":"22 3","pages":"223"},"PeriodicalIF":3.0,"publicationDate":"2022-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/44/48/40268_2022_Article_401.PMC9433611.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40636628","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: The Pitfalls of Abnormal Laboratory Value Interpretation in Vaccine Clinical Trials: The Example of Asymptomatic Transient Neutropenia.","authors":"Venanzio Vella,&nbsp;Johannes E Schmidt,&nbsp;Giulia Luna Cilio,&nbsp;Iris De Ryck,&nbsp;Audino Podda,&nbsp;Valentino Conti,&nbsp;Joachim Auerbach","doi":"10.1007/s40268-022-00395-2","DOIUrl":"https://doi.org/10.1007/s40268-022-00395-2","url":null,"abstract":"","PeriodicalId":49258,"journal":{"name":"Drugs in Research & Development","volume":"22 3","pages":"253"},"PeriodicalIF":3.0,"publicationDate":"2022-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f3/26/40268_2022_Article_395.PMC9433636.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40718116","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Roxadustat for SARS-CoV-2 Infection: Old Signaling Raised New Hopes.","authors":"Luay Alkazmi,&nbsp;Hayder M Al-Kuraishy,&nbsp;Gaber El-Saber Batiha,&nbsp;Gomaa Mostafa-Hedeab,&nbsp;Michel De Waard,&nbsp;Jean-Marc Sabatier,&nbsp;Saeed M Kabrah,&nbsp;Hebatallah M Saad,&nbsp;Ali I Al-Gareeb,&nbsp;Jesus Simal-Gandara","doi":"10.1007/s40268-022-00397-0","DOIUrl":"https://doi.org/10.1007/s40268-022-00397-0","url":null,"abstract":"","PeriodicalId":49258,"journal":{"name":"Drugs in Research & Development","volume":"22 3","pages":"183-186"},"PeriodicalIF":3.0,"publicationDate":"2022-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/39/a3/40268_2022_Article_397.PMC9403957.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40638793","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preclinical and Toxicology Studies of BRD5529, a Selective Inhibitor of CARD9.","authors":"Theodore J Kottom, Kyle Schaefbauer, Eva M Carmona, Eunhee S Yi, Andrew H Limper","doi":"10.1007/s40268-022-00389-0","DOIUrl":"10.1007/s40268-022-00389-0","url":null,"abstract":"<p><strong>Background: </strong>The caspase recruitment domain-containing protein 9 (CARD9) inhibitor BRD5529 has been shown to be an effective in vitro inhibitor of Pneumocystis β-glucan-induced proinflammatory signaling, suggesting its viability as a candidate for preliminary anti-Pneumocystis drug testing in the rodent Pneumocystis pneumonia (PCP) model.</p><p><strong>Methods: </strong>Mice were injected intraperitoneally (IP) daily with either vehicle or BRD5529 at 0.1 or 1.0 mg/kg for 2 weeks. Mouse weights were taken daily. At day 14, mice were euthanized, weighed, and analyzed by flexiVent™ for lung stiffness. Lungs, liver, and kidney were then harvested for hematoxylin and eosin (H&E) staining and pathology scoring. Lung samples were further analyzed for proinflammatory cytokines via enzyme-linked immunosorbent assay (ELISA) and extracellular matrix generation via quantitative polymerase chain reaction (qPCR). Blood collection postmortem was performed for blood chemistry analysis. Furthermore, administration of BRD5529 prior to the intratracheal inoculation of fungal β-glucans, which are known proinflammatory mediators via the Dectin-1-CARD9 pathway, resulted in significant reductions in lung tissue interleukin-6 and tumor necrosis factor-α, suggesting the exciting possibility of the use of this CARD9 inhibitor as an additional therapeutic tool in fungal infections.</p><p><strong>Results: </strong>BRD5529 at both IP doses resulted in no significant changes in daily or final weight gain, and analysis of lung stiffness by flexiVent™ showed no significant differences between the groups. Furthermore, ELISA results of proinflammatory cytokines showed no major differences in the respective groups. qPCR analysis of extracellular matrix transcripts were statistically similar. Examination and pathology scoring of H&E slides from lung, liver, and kidney in all groups, as well as subsequent pathology scoring, showed no significant change. Blood chemistry analysis revealed similar, non-significant patterns.</p><p><strong>Conclusions: </strong>In our initial general safety and toxicology assessments, BRD5529 displayed no inherent safety concerns in the analyzed parameters. These data support broader in vivo testing of the inhibitor as a timed adjunct therapy to the deleterious proinflammatory host immune response often associated with anti-Pneumocystis therapy.</p>","PeriodicalId":49258,"journal":{"name":"Drugs in Research & Development","volume":"22 1","pages":"165-173"},"PeriodicalIF":3.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9167333/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48641677","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hydroxychloroquine Blood Concentrations Can Be Clinically Relevant Also After Drug Discontinuation.","authors":"Simona De Gregori,&nbsp;Francesco Falaschi,&nbsp;Alessia Ballesio,&nbsp;Alessandra Fusco,&nbsp;Elisa Cremonte,&nbsp;Roberta Canta,&nbsp;Umberto Sabatini,&nbsp;Mariadelfina Molinaro,&nbsp;Carlo Soffiantini,&nbsp;Alba Nardone,&nbsp;Alessandro Vicentini,&nbsp;Annalisa De Silvestri,&nbsp;Antonio Di Sabatino","doi":"10.1007/s40268-022-00387-2","DOIUrl":"https://doi.org/10.1007/s40268-022-00387-2","url":null,"abstract":"<p><strong>Background and objective: </strong>Hydroxychloroquine was widely used during the severe acute respiratory syndrome coronavirus 2 pandemic as an antiviral drug. Most previous pharmacokinetic/pharmacodynamic studies on hydroxychloroquine were conducted on healthy volunteers or patients receiving long-term therapy. There are no studies on the elimination of hydroxychloroquine after short-term treatments. Hydroxychloroquine is known to have a pro-arrhythmic effect through QT interval prolongation, but data in this setting are not conclusive. Our aims were to estimate the time needed for hydroxychloroquine concentrations (C_HCQ) to drop to a safe concentration (500 ng/mL) after a short-term therapeutic cycle and to correlate the corrected QT interval with C_HCQ.</p><p><strong>Methods: </strong>We collected blood samples and electrocardiograms of patients who underwent short-term therapy with hydroxychloroquine during drug intake and after discontinuation. Hydroxychloroquine concentrations were determined by high-performance liquid chromatography-tandem mass spectrometry and analysed with a linear regression model to estimate the elimination time of the drug after its discontinuation. We conducted a multivariate analysis of the corrected QT interval correlation with C_HCQ.</p><p><strong>Results: </strong>Our data suggest that short-term hydroxychloroquine courses can generate significant C_HCQ persisting above 500 ng/mL up to 16 days after discontinuation of treatment. Corrected QT interval prolongation significantly correlates with C_HCQ.</p><p><strong>Conclusions: </strong>The study confirms the long half-life of hydroxychloroquine and its effect on the corrected QT interval even after short-term courses of the drug. This can inform the clinician using hydroxychloroquine treatments that it would be safer to start or re-initiate treatments with corrected QT interval-prolonging potential 16 days after hydroxychloroquine discontinuation.</p>","PeriodicalId":49258,"journal":{"name":"Drugs in Research & Development","volume":"22 2","pages":"155-163"},"PeriodicalIF":3.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/70/5d/40268_2022_Article_387.PMC9103606.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10598180","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacokinetics and Safety of Ferric Pyrophosphate Citrate in Chinese Subjects with and without Hemodialysis-Dependent Stage 5 Chronic Kidney Disease.","authors":"Liangying Gan,&nbsp;Panpan Xie,&nbsp;Yan Tan,&nbsp;Gang Wei,&nbsp;Xiaojuan Yuan,&nbsp;Zhifei Lu,&nbsp;Raymond Pratt,&nbsp;Yongchun Zhou,&nbsp;Ai-Min Hui,&nbsp;Kexin Li,&nbsp;Yi Fang,&nbsp;Li Zuo","doi":"10.1007/s40268-022-00384-5","DOIUrl":"https://doi.org/10.1007/s40268-022-00384-5","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background and objective: &lt;/strong&gt;Anemia caused by iron depletion is common in patients with hemodialysis-dependent stage 5 chronic kidney disease (CKD-5HD) patients. To maintain the iron levels, external administration of iron is essential. Ferric pyrophosphate citrate (FPC) is a novel, water-soluble complex iron salt. The present study was conducted to evaluate the pharmacokinetic (PK) parameters and safety of FPC in adult healthy Chinese subjects and patients with CKD-5HD.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Two open-label, single-center studies were conducted in healthy subjects and patients with CKD-5HD. Healthy subjects received a single intravenous dose of 6.5 mg FPC solution, while CKD-5HD patients were randomized to two different sequences of FPC administration at two sequential hemodialysis (HD) treatments (dose 1 and dose 2). Patients received 27.2 mg of FPC at a dialysate concentration of 95 μg/L for 4 h or a single 6.5 mg dose of FPC administered intravenously via the pre-dialyzer blood circuit. The primary objective was to determine the PK parameters of total serum iron (Fe&lt;sub&gt;tot&lt;/sub&gt;), while the secondary objective was the safety of the FPC solution. PK parameters were calculated using Phoenix WinNonlin 8.1 and other parameters were analyzed using SAS 9.4 software. Comparison between HD dose 2 and HD dose 1 was performed using the Wilcoxon rank-sum test and analysis of variance (ANOVA).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 14 healthy subjects with a mean age of 30.8 ± 5.92 years and 12 HD patients with a mean age of 54.3 ± 16.47 years were included. In healthy subjects, the peak serum concentration was reached at the end of infusion of FPC, with an adjusted mean maximum concentration (C&lt;sub&gt;max,&lt;/sub&gt;) of 33.46 ± 4.83 μmol/L at a mean time to reach C&lt;sub&gt;max&lt;/sub&gt; (T&lt;sub&gt;max&lt;/sub&gt;) of 4.09 ± 0.19 h. In patients with CKD-5HD, the adjusted mean C&lt;sub&gt;max&lt;/sub&gt; of HD dose 2 was 25.37 ± 4.30 μmol/L at a T&lt;sub&gt;max,&lt;/sub&gt; of 3.09 ± 0.32 h, whereas the C&lt;sub&gt;max,&lt;/sub&gt; of HD dose 1 was 24.59 ± 4.77 μmol/L at a T&lt;sub&gt;max,&lt;/sub&gt; of 3.96 ± 0.26 h. The Fe&lt;sub&gt;tot&lt;/sub&gt; concentration-time curves were observed to be similar for both administration methods (HD doses 1 and 2), while the PK parameters differed significantly for T&lt;sub&gt;max&lt;/sub&gt; (p = 0.001; baseline correction) and area under the concentration-time curve from time zero to time t (AUC&lt;sub&gt;t&lt;/sub&gt;) [p = 0.031 for cycle variance; without baseline correction] between HD doses 1 and 2. The geometric mean ratios (HD dose 1/HD dose 2) for C&lt;sub&gt;max&lt;/sub&gt; and AUC&lt;sub&gt;t&lt;/sub&gt; were within the 85-125% range (C&lt;sub&gt;max&lt;/sub&gt; 96.56%; AUC&lt;sub&gt;t&lt;/sub&gt; 96.07%). A total of three and two incidences of adverse events were reported in healthy subjects and patients with CKD-5HD, respectively.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;FPC showed a good PK and safety profile and hence can be used as maintenance therapy for patients with CKD-5HD by choosing a better method of administration based","PeriodicalId":49258,"journal":{"name":"Drugs in Research & Development","volume":"22 2","pages":"119-129"},"PeriodicalIF":3.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f7/8b/40268_2022_Article_384.PMC9167373.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10250876","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of the Pharmacokinetics and Safety of AMG 986 Tablet and Capsule Formulations in Healthy Adult Subjects: A Phase I, Open-Label, Randomized Study.","authors":"Ashit Trivedi,&nbsp;Y-H Kiang,&nbsp;Robert E Saw,&nbsp;Guilong Charles Cheng,&nbsp;Omar Mather,&nbsp;Silvia Vega,&nbsp;Jennifer Hellawell,&nbsp;Edward Lee","doi":"10.1007/s40268-022-00388-1","DOIUrl":"10.1007/s40268-022-00388-1","url":null,"abstract":"<p><strong>Background and objective: </strong>AMG 986 is a first-in-class, novel apelin receptor small molecule agonist initially developed for the treatment of heart failure. The current phase I study was conducted to evaluate the pharmacokinetics and safety of a single-dose 200-mg capsule formulation of AMG 986 relative to the tablet formulation in 12 healthy subjects.</p><p><strong>Methods: </strong>In a two-period, two-way crossover design, eligible subjects were randomized 1:1 to tablet/capsule or capsule/tablet treatment sequences; each treatment sequence lasted for approximately 6 days and comprised six subjects.</p><p><strong>Results: </strong>Following a single oral dose of AMG 986, the geometric mean maximum observed concentration (C_max) values were 9670 ng/mL and 6920 ng/mL and the geometric mean area under the curve from time zero to 120 h (AUC_0-120h) values were 68,000 ng*h/mL and 59,900 ng*h/mL for the tablet and capsule, respectively. The geometric least squares means (90% confidence interval [90% CI]) for the ratios of capsule/tablet were 0.88 (90% CI 0.81-0.96) and 0.72 (90% CI 0.57-0.91) for AUC_0-120h and C_max, respectively. AMG 986 had an acceptable safety profile; all adverse events were grade 1 or 2 in severity.</p><p><strong>Conclusion: </strong>There was a modest 12% decrease in AUC_0-120h and a 28% decrease in C_max with the AMG 986 capsule versus the tablet. These differences are not considered to be clinically relevant, suggesting the capsule formulation can be used in subsequent clinical studies of AMG 986.</p>","PeriodicalId":49258,"journal":{"name":"Drugs in Research & Development","volume":"22 1","pages":"147-154"},"PeriodicalIF":3.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9167409/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43191545","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of the Effect of Food on the Pharmacokinetics of SHR6390, An Oral CDK4/6 Inhibitor, in Healthy Volunteers","authors":"Yan-ping Liu, M. Hu, Ping-ping Lin, Ting Li, Shu-qin Liu, Yu-ya Wang, Shaorong Li, Xiang-kun Li, Chenjing Wang, Yu Cao","doi":"10.1007/s40268-022-00390-7","DOIUrl":"https://doi.org/10.1007/s40268-022-00390-7","url":null,"abstract":"","PeriodicalId":49258,"journal":{"name":"Drugs in Research & Development","volume":"22 1","pages":"175 - 182"},"PeriodicalIF":3.0,"publicationDate":"2022-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41525667","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}