Author ’s Reply to Petersen: “Differences in In Vitro Properties of Pancreatin Preparations for Pancreatic Exocrine Insufficiency as Marketed in Russia and CIS”
(Source: Drugs in R&D)
Source: Drugs in R&D - October 23, 2021 Category: Drugs & Pharmacology Source Type: research
Comment on: “Differences in In Vitro Properties of Pancreatin Preparations for Pancreatic Exocrine Insufficiency as Marketed in Russia and CIS”
(Source: Drugs in R&D)
Source: Drugs in R&D - October 20, 2021 Category: Drugs & Pharmacology Source Type: research
Effects of Letermovir and/or Methylprednisolone Coadministration on Voriconazole Pharmacokinetics in Hematopoietic Stem Cell Transplantation: A Population Pharmacokinetic Study
ConclusionsThe development of individualized dose adjustment is critical to achieve optimal voriconazole concentration, especially among allo-HSCT recipients receiving concomitant letermovir and/or methylprednisolone. (Source: Drugs in R&D)
Source: Drugs in R&D - October 15, 2021 Category: Drugs & Pharmacology Source Type: research
Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus
ConclusionsIn Chinese pediatric patients with SLE, belimumab 10 mg/kg IV every 4 weeks is expected to have exposure similar to that in Chinese adults and non-Chinese pediatric patients with SLE, supporting the use of this regimen in Chinese pediatric patients with SLE.Clinical Trial Registration NumbersNCT01649765, NCT00657007, NCT00071487, NCT01345253, NCT01516450, NCT00410384, NCT00424476, NCT02880852, NCT01583530. (Source: Drugs in R&D)
Source: Drugs in R&D - October 9, 2021 Category: Drugs & Pharmacology Source Type: research
Dissociated Responses in Patients with Metastatic Solid Tumors Treated with Immunotherapy
ConclusionsA DR was observed in 8% of patients. Response rate was lower in the case of prior radiotherapy and higher in the case of prior biopsy. (Source: Drugs in R&D)
Source: Drugs in R&D - September 25, 2021 Category: Drugs & Pharmacology Source Type: research
The Safety of Agalsidase Alfa Enzyme Replacement Therapy in Canadian Patients with Fabry Disease Following Implementation of a Bioreactor Process
ConclusionsLong-term treatment with bioreactor-produced agalsidase alfa animal component-free did not reveal new safety signals in this population of Canadian patients with Fabry disease. The treatment-emergent adverse event profile was consistent with the clinical manifestations of the disease and the known safety profile of roller bottle-produced agalsidase alfa.Clinical Trial RegistrationClinicalTrials.gov identifier NCT01298141. (Source: Drugs in R&D)
Source: Drugs in R&D - September 20, 2021 Category: Drugs & Pharmacology Source Type: research
Improvement of Intranasal Drug Delivery with Intravail ® Alkylsaccharide Excipient as a Mucosal Absorption Enhancer Aiding in the Treatment of Conditions of the Central Nervous System
AbstractIntranasal drug administration is a commonly used route for therapeutic formulations, but there may be challenges associated with a lack of absorption and bioavailability, as well as damage to mucosal tissue. To address these issues, potential absorption enhancers that are generally nonirritating to nasal mucosal tissue have been investigated as excipients in intranasal formulations. Among those studied are alkylsaccharides, which are composed of sugars covalently coupled to at least one alkyl chain. Alkylsaccharides have been shown to be nontoxic and have been used in food products as emulsifiers. In clinical tria...
Source: Drugs in R&D - August 25, 2021 Category: Drugs & Pharmacology Source Type: research
Apixaban Pharmacokinetics and Pharmacodynamics in Subjects with Mild or Moderate Hepatic Impairment
ConclusionsMild or moderate hepatic impairment had no clinically relevant impact on apixaban pharmacokinetic or pharmacodynamic measures, suggesting that dose adjustment may not be required. (Source: Drugs in R&D)
Source: Drugs in R&D - August 7, 2021 Category: Drugs & Pharmacology Source Type: research
Delayed Cutaneous Hypersensitivity Reaction to Vaxzevria (ChAdOx1-S) Vaccine against SARS-CoV-2
We describe a delayed large local cutaneous reaction in a patient who received the viral vector vaccine Vaxzevria (ChAdOx1-S, AstraZeneca). The time course and clinical symptoms of delayed skin reaction after mRNA vaccines have a similar pattern that we recognized in our patient after Vaxzevria vaccination. This phenomenon has not been described in the Vaxzevria clinical trials and is to our knowledge the first report of this adverse reaction to a vector-based SARS-CoV-2 vaccine. With this, we hope to raise awareness about delayed injection site reactions that also occur after viral vector vaccines and to encourage additio...
Source: Drugs in R&D - August 5, 2021 Category: Drugs & Pharmacology Source Type: research
Safety and Systemic Exposure of Triamcinolone Acetonide Following Ultrasound-Guided Intra-Articular Injection of Triamcinolone Extended-Release or Standard Triamcinolone Acetonide in Patients with Shoulder Osteoarthritis: An Open-Label, Randomized Study
ConclusionThese pharmacokinetic data confirm protracted release of TA from TA-ER following IA injection in patients with shoulder OA. Lower peak and systemic TA exposure following TA-ER suggests TA-ER could potentially confer an improved systemic safety profile over TAcs.Trial Registration NumberNCT03382262 (December 22, 2017 retrospectively registered). (Source: Drugs in R&D)
Source: Drugs in R&D - August 4, 2021 Category: Drugs & Pharmacology Source Type: research
A Novel Therapeutic Peptide Blocks SARS-CoV-2 Spike Protein Binding with Host Cell ACE2 Receptor
ConclusionsBlockage of binding of the SARS-CoV-2 spike protein with ACE2 in the presence of the 13AApi may prevent virus entry into host cells. Therefore, the 13AApi can be utilized as a promising therapeutic agent to combat coronavirus disease 2019. (Source: Drugs in R&D)
Source: Drugs in R&D - July 29, 2021 Category: Drugs & Pharmacology Source Type: research
A Novel In Vitro Model for Determining the Optimum pH and Dose Volume of New Liquid Alginate for Infant Reflux Suppression
ConclusionThis study confirms the mode of action of the alginate formula, demonstrating a superior reduction in the retrograde movement of in vitro gastric contents and volume of regurgitation. The study also demonstrates that optimal performance occurs in conditions that are in line physiologically with the target patient. Both actions compliment and support the efficacy of the alginate formulation as a reflux therapy agent. (Source: Drugs in R&D)
Source: Drugs in R&D - July 20, 2021 Category: Drugs & Pharmacology Source Type: research
Predicting Inter-individual Variability During Lipid Resuscitation of Bupivacaine Cardiotoxicity in Rats: A Virtual Population Modeling Study
ConclusionOur results represent a successful prediction of complex, dynamic physiological outcomes over a virtual population. Despite being informed by very limited data, our mechanistic model predicted a plausible range of treatment outcomes that accurately predicts changes in LD50 when extrapolated to putatively toxic doses of bupivacaine. Furthermore, causal analysis of the predicted survival outcomes indicated a critical synergy between scavenging and direct cardiotonic mechanisms of ILE action. (Source: Drugs in R&D)
Source: Drugs in R&D - July 19, 2021 Category: Drugs & Pharmacology Source Type: research
Long-Term Maintenance of Golimumab Effectiveness for Injection Spacing in Rheumatoid Arthritis Patients with Low Disease Activity Who Previously Received Other TNF Inhibitors: Minimum 2-year Data From an Observational Study
ConclusionAdministration of GLM-SC at 4-week and 8-week intervals after switching from TNF inhibitors showed sustained long-term efficacy and acceptable safety in RA patients with low disease activity. (Source: Drugs in R&D)
Source: Drugs in R&D - June 25, 2021 Category: Drugs & Pharmacology Source Type: research
Safety and Pharmacokinetics of HTL0018318, a Novel M1 Receptor Agonist, Given in Combination with Donepezil at Steady State: A Randomized Trial in Healthy Elderly Subjects
ConclusionHTL0018318 was well tolerated when given alone and in combination with donepezil. HTL0018318 and donepezil do not demonstrate pharmacokinetic or pharmacodynamic interactions, indicating that HTL0018318 can be safely administered in combination with donepezil.Clinical trial registrationNetherlands Trial register identifier NL5915, registered on 28 October 2016. (Source: Drugs in R&D)
Source: Drugs in R&D - June 23, 2021 Category: Drugs & Pharmacology Source Type: research
