Indirect Comparison of Lanadelumab and Intravenous C1-INH Using Data from the HELP and CHANGE Studies: Bayesian and Frequentist Analyses
ConclusionsFindings from these two ITC methodologies support the favorable efficacy of lanadelumab in reducing the HAE attack rate and extending attack-free intervals in patients with HAE. (Source: Drugs in R&D)
Source: Drugs in R&D - March 1, 2021 Category: Drugs & Pharmacology Source Type: research
S100 Genes are Highly Expressed in Peripheral Leukocytes of Type 2 Diabetes Mellitus Patients Treated with Dietary Therapy
ConclusionsS100 genes were more highly expressed in T2DM patients with dietary therapy than in healthy volunteers. (Source: Drugs in R&D)
Source: Drugs in R&D - January 19, 2021 Category: Drugs & Pharmacology Source Type: research
Effect of Food on the Pharmacokinetics of the Oral Docetaxel Tablet Formulation ModraDoc006 Combined with Ritonavir (ModraDoc006/r) in Patients with Advanced Solid Tumours
ConclusionsThe docetaxel and ritonavir exposure were not bioequivalent, as consumption of a high-fat meal prior to administration of ModraDoc006/r resulted in a slightly higher docetaxel exposure and lower ritonavirCmax. Since docetaxel exposure is the only clinically relevant parameter in our patient population, the overall conclusion is that combined ModraDoc006 and ritonavir treatment may be slightly affected by concomitant intake of a high-fat meal. In view of the small effect, it is most likely that the intake of a light meal will not affect the systemic exposure to docetaxel.ClinicalTrials.gov IdentifierNCT03147378, ...
Source: Drugs in R&D - January 19, 2021 Category: Drugs & Pharmacology Source Type: research
Analyzing the Efficacy of Isotretinoin in Treating Dissecting Cellulitis: A Literature Review and Meta-Analysis
ConclusionsIsotretinoin is an effective treatment for improving symptoms of dissecting cellulitis of the scalp. Disease recurrence is a common finding for those who undergo successful treatment. (Source: Drugs in R&D)
Source: Drugs in R&D - January 2, 2021 Category: Drugs & Pharmacology Source Type: research
Effect of Preoperative Infusion of Levosimendan on Biomarkers of Myocardial Injury and Haemodynamics After Paediatric Cardiac Surgery: A Randomised Controlled Trial
ConclusionsLevosimendan does not significantly improve patients ’ postoperative troponin I and B-type natriuretic peptide profiles during the immediate postoperative stage in comparison with placebo, although both were numerically higher with placebo. Levosimendan, however, significantly reduced lactic acid levels and improved patients’ DO2 profiles. These results highlight the importance of this new drug and its possible benefit with regard to myocardial injury; however, evaluation in larger, adequately powered trials is needed to determine the efficacy of levosimendan.Trial registry number: EudraCT 2012-005310-19. (Source: Drugs in R&D)
Source: Drugs in R&D - December 24, 2020 Category: Drugs & Pharmacology Source Type: research
Standardization and Chemical Characterization of Intravenous Therapy in Adult Patients: A Step Further in Medication Safety
ConclusionsIncreasing safety of intravenous therapy should be a priority in the healthcare settings. Knowing the characteristics of drugs to assess the risk involved in their administration related to their physicochemical nature may be useful to guide decision making regarding the most appropriate vascular access and devices. (Source: Drugs in R&D)
Source: Drugs in R&D - December 21, 2020 Category: Drugs & Pharmacology Source Type: research
Safety and Antitumor Activity of Repeated ASP3026 Administration in Japanese Patients with Solid Tumors: A Phase I Study
ConclusionASP3026 at a 200-mg dose may provide therapeutic benefit for patients with solid tumors, with a tolerable safety profile.Clinical Trial registrationThis study is registered at ClinicalTrials.gov under the identifier NCT01401504 on July 25, 2011 (Source: Drugs in R&D)
Source: Drugs in R&D - December 17, 2020 Category: Drugs & Pharmacology Source Type: research
Recommendations for Dosing of Repurposed COVID-19 Medications in Patients with Renal and Hepatic Impairment
ConclusionDosing of drugs used to treat COVID-19 in patients with renal or hepatic impairment is complex. These recommendations were produced to provide guidance to clinicians worldwide who are treating patients with COVID-19, many of whom will have some degree of acute or chronic renal or hepatic impairment. (Source: Drugs in R&D)
Source: Drugs in R&D - December 17, 2020 Category: Drugs & Pharmacology Source Type: research
Dosing Considerations for Antibodies Against COVID-19
AbstractAt present, no cure is available for COVID-19 but vaccines, antiviral drugs, immunoglobulins, or the combination of immunoglobulins with antiviral drugs have been suggested and are in clinical trials. The purpose of this paper is to discuss the role of a pharmacokinetic and viral load analysis as a basis for adjusting immunoglobulin dosing to treat COVID-19. We reviewed the pre-clinical and clinical literature that describes the impact of a high antigen load on pharmacokinetic data following antibody treatment. Representative examples are provided to illustrate the effect of high viral and tumor loads on antibody c...
Source: Drugs in R&D - December 1, 2020 Category: Drugs & Pharmacology Source Type: research
Differences in In Vitro Properties of Pancreatin Preparations for Pancreatic Exocrine Insufficiency as Marketed in Russia and CIS
ConclusionPancreatin preparations available in Russia and CIS demonstrate product-to-product and batch-to-batch variability regarding the measured properties of lipase activity, dissolution, and particle size. This may impact the efficacy of PERT and therefore clinical outcomes. (Source: Drugs in R&D)
Source: Drugs in R&D - November 19, 2020 Category: Drugs & Pharmacology Source Type: research
A GFR-Based Method to Predict the Effect of Renal Impairment on the Exposure or Clearance of Renally Excreted Drugs: A Comparative Study Between a Simple GFR Method and a Physiologically Based Pharmacokinetic Model
ConclusionsThis study indicates that the predictive power of a simple GFR model is similar to a PBPK model for the prediction of clearance or area under the curve in subjects with renal impairment. The GFR method is simple, robust, and reliable and can replace complex empirical PBPK models. (Source: Drugs in R&D)
Source: Drugs in R&D - November 4, 2020 Category: Drugs & Pharmacology Source Type: research
Acknowledgement to Referees
(Source: Drugs in R&D)
Source: Drugs in R&D - November 3, 2020 Category: Drugs & Pharmacology Source Type: research
Current PBPK Models: Are They Predicting Tissue Drug Concentration Correctly?
(Source: Drugs in R&D)
Source: Drugs in R&D - October 17, 2020 Category: Drugs & Pharmacology Source Type: research
A Pharmacokinetic Bridging Study to Compare Systemic Exposure to Budesonide between Budesonide Oral Suspension and ENTOCORT EC in Healthy Individuals
ConclusionsThis study demonstrated that systemic exposure to budesonide after a single oral dose of BOS 2 mg was lower than that after a single oral dose of ENTOCORT EC 9 mg. These results provide PK bridging data to compare BOS with therapeutic doses of ENTOCORT EC with respect to safety information. (Source: Drugs in R&D)
Source: Drugs in R&D - October 15, 2020 Category: Drugs & Pharmacology Source Type: research
Comparisons of Four Protein-Binding Models Characterizing the Pharmacokinetics of Unbound Phenytoin in Adult Patients Using Non-Linear Mixed-Effects Modeling
ConclusionsThe linear binding model best described the population pharmacokinetics of unbound phenytoin in adult subjects and may be used to improve the prediction of free phenytoin concentrations. (Source: Drugs in R&D)
Source: Drugs in R&D - October 6, 2020 Category: Drugs & Pharmacology Source Type: research
