Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU- Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar Development?
ConclusionOur analysis reveals that, in most cases, the reference biological products originated from the EU and those from the USA are almost indistinguishable in terms of PK/PD properties. Additional in vivo bridging studies between reference products from different global regions may not be required if similar physicochemical and structural properties are evident in vitro. (Source: BioDrugs)
Source: BioDrugs - May 19, 2019 Category: Drugs & Pharmacology Source Type: research
Identification of recombinant human insulin and biosynthetic insulin analogues by multiplexed targeted unlabeled mass spectrometry of proteotypic tryptic peptides
Publication date: Available online 1 May 2019Source: Journal of Pharmaceutical and Biomedical AnalysisAuthor(s): Rani J. Qasem, Anas S. Aldawsari, Faisal E. Almutairi, Abdullah S AlsadoonAbstractDirect qualitative methods that allow the rapid screening and identification of insulin products during early stages of the drug development process and those already in the market can be of great utility for manufacturers and regulatory agencies and the recent scientific literature describes several methods. Herein, a qualitative proteomic method is presented for the identification of recombinant human insulin and all marketed bio...
Source: Journal of Pharmaceutical and Biomedical Analysis - May 2, 2019 Category: Drugs & Pharmacology Source Type: research
Opioid analgesics are the leading cause of adverse drug reactions in the obstetric population in South Korea
Medication use during pregnancy is gradually increasing; however, the safety of this practice remains largely unknown.
We investigated medications with the most adverse drug reactions (ADRs) among pregnant women and the clinical features of those medications.
Reports of ADRs among pregnant women were extracted from the Korea Adverse Events Reporting System (January 2012–December 2015). We analyzed the data of drugs frequently reported to cause ADRs and their clinical features among 3 age groups.
A total of 5642 ADRs among 3428 patients were analyzed. The number of ADR reports increased annually. The most common drug c...
Source: Medicine - May 1, 2019 Category: Internal Medicine Tags: Research Article: Observational Study Source Type: research
Expanded Table: Some Available Insulins for Type 2 Diabetes (online only)
Date: May 6, 2019
Issue #:
1571Summary:
View the Expanded Table: Some Available Insulins (Source: The Medical Letter)
Source: The Medical Letter - April 26, 2019 Category: Drugs & Pharmacology Authors: admin Tags: Admelog Afrezza Apidra Basaglar degludec Fiasp glargine Humalog Humulin insulin Lantus levemir Liraglutide lixisenatide Novolin Novolog Novorapid ReliOn Soliqua Toujeo Tresiba type 2 diabetes Xultophy Source Type: research
Insulins for Type 2 Diabetes
Date: May 6, 2019
Issue #:
1571Summary:
The goal of drug therapy for type 2 diabetes is to achieve
and maintain a near-normal glycated hemoglobin
(A1C) concentration without inducing hypoglycemia;
for most patients, the target A1C is<7%. Metformin
is the preferred first-line treatment, but most patients
with type 2 diabetes eventually require multidrug
therapy and/or insulin to achieve glycemic control. (Source: The Medical Letter)
Source: The Medical Letter - April 3, 2019 Category: Drugs & Pharmacology Authors: admin Tags: Admelog Afrezza Apidra Basaglar degludec Detemir Fiasp glargine Humalog Humulin insulin Lantus levemir Liraglutide lixisenatide Novolin Novolog Novorapid ReliOn Soliqua Toujeo Tresiba type 2 diabetes Xultophy Source Type: research
Development and validation of a noncompetitive electrochemiluminescence-based immunoassay (ECLIA) for specific determination of insulin lispro (Humalog ®) in human serum to support pharmacokinetic assessments.
We report herein development of the first noncompetitive electrochemiluminescence-based immunoassay (ECLIA) for specific determination of insulin lispro in serum or plasma. The new sandwich ECLIA permits accurate assessment of insulin lispro pharmacokinetics without interference from endogenous insulin. Integral to the development of this specific immunoassay was establishment of a proprietary process for affinity production of an oligoclonal monospecific guinea pig antiserum to the unique subtle structural modification in insulin lispro. We specifically optimized the ECLIA to provide reliable performance for supporting ph...
Source: Journal of Immunoassay and Immunochemistry - March 30, 2019 Category: Biochemistry Tags: J Immunoassay Immunochem Source Type: research
Establishment of the First National Reference Standard for Insulin Lispro: Report of a collaborative study
Publication date: Available online 11 January 2019Source: BiologicalsAuthor(s): Gurminder Bindra, Gaurav Pratap Singh Jadaun, Shruti Dixit, Vandana Saklani, Zafar Abbas, Parveen Jain, Kim B. Dancheck, Matthew W. Borer, Meena Kumari, Charu Mehra Kamal, Renu Jain, Surinder Singh, Participants of the StudyAbstractThe present study was aimed to establish the First National Reference Standard (NRS) for Insulin lispro to allow stakeholders including manufacturer's laboratories, drug testing laboratories, drug regulatory authorities and academic institutions to demonstrate accuracy of the test results and to enable comparison and...
Source: Biologicals - January 12, 2019 Category: Biology Source Type: research
Establishment of the First National Reference Standard for Insulin Lispro: Report of a collaborative study.
Abstract
The present study was aimed to establish the First National Reference Standard (NRS) for Insulin lispro to allow stakeholders including manufacturer's laboratories, drug testing laboratories, drug regulatory authorities and academic institutions to demonstrate accuracy of the test results and to enable comparison and validation of analytical methods. The candidate standard for Insulin lispro was evaluated in a collaborative study to assign the vial content in order to serve it as NRS to support the Indian Pharmacopoeia (IP) monograph. The candidate standard was calibrated against the Ph. Eur. Insu...
Source: Biologicals : Journal of the International Association of Biological Standardization - January 10, 2019 Category: Biotechnology Authors: Bindra G, Jadaun GPS, Dixit S, Saklani V, Abbas Z, Jain P, Dancheck KB, Borer MW, Kumari M, Kamal CM, Jain R, Singh S, Participants of the Study Tags: Biologicals Source Type: research
Efficacy Comparison of Preprandial and Postprandial Prandilin 25 Administration in Patients with Newly Diagnosed Type 2 Diabetes Using a Continuous Glucose Monitoring System
ConclusionIn patients with T2DM managed with premixed insulin lispro 25, postprandial injection (within 30 min of meal onset) may be an acceptable alternative to preprandial injection when the regular preprandial insulin dose is omitted.Trial RegistrationChinese Clinical Trial Register identifier: ChiCTR1800015828. (Source: Diabetes Therapy)
Source: Diabetes Therapy - January 4, 2019 Category: Endocrinology Source Type: research
Development and validation of a new UHPLC method for related proteins in insulin and insulin analogues as an alternative to the European Pharmacopoeia RP-HPLC method
Publication date: Available online 23 December 2018Source: Journal of Pharmaceutical and Biomedical AnalysisAuthor(s): Oliver Wahl, Sylvie JorajuriaAbstractThe LC methods for related proteins prescribed in the European Pharmacopoeia monographs for insulins and insulin analogues are very similar and present some drawbacks including long run time and low resolution. LC to UHPLC-UV geometrical transfer was attempted to overcome such drawbacks. With the new UHPLC method, additional substances were separated in bovine and porcine insulins. A UHPLC MS-compatible method was developed using a mixed-mode C18 stationary phase with c...
Source: Journal of Pharmaceutical and Biomedical Analysis - December 25, 2018 Category: Drugs & Pharmacology Source Type: research
Concentrated Insulins in Current Clinical Practice
New concentrated insulins (exceeding 100 units/mL) and dedicated devices have recently become available, offering new treatment options for people with diabetes, for basal and prandial insulin supplementation. The concentrated insulin formulations range from 2-fold concentration (insulin lispro 200 units/mL) with rapid-acting prandial action to 5-fold concentration (human regular insulin, 500 units/mL) with basal and short-acting prandial actions. Long-acting basal insulins include degludec 200 units/mL and glargine 300 units/mL. (Source: Diabetes Research and Clinical Practice)
Source: Diabetes Research and Clinical Practice - December 21, 2018 Category: Endocrinology Authors: Nanette C. Schloot, Robert C. Hood, Sheila M. Corrigan, Robert L. Panek, Tim Heise Source Type: research
Short-acting insulin analogues versus regular human insulin for adult, non-pregnant persons with type 2 diabetes mellitus.
CONCLUSIONS: Our analysis found no clear benefits of short-acting insulin analogues over regular human insulin in people with type 2 diabetes. Overall, the certainty of the evidence was poor and results on patient-relevant outcomes, like all-cause mortality, microvascular or macrovascular complications and severe hypoglycaemic episodes were sparse. Long-term efficacy and safety data are needed to draw conclusions about the effects of short-acting insulin analogues on patient-relevant outcomes.
PMID: 30556900 [PubMed - as supplied by publisher] (Source: Cochrane Database of Systematic Reviews)
Source: Cochrane Database of Systematic Reviews - December 17, 2018 Category: General Medicine Authors: Fullerton B, Siebenhofer A, Jeitler K, Horvath K, Semlitsch T, Berghold A, Gerlach FM Tags: Cochrane Database Syst Rev Source Type: research
Comparator clinical trials of surrogate endpoints with albiglutide are in HARMONY.
Authors: Doggrell SA
Abstract
Evaluation of: Ahrén B, Johnson SL, Stewart M et al. HARMONY 3: 104-Week randomized, double-blind, placebo- and active-controlled trial assessing the efficacy and safety of albiglutide compared with placebo, sitagliptin, and glimepiride in patients with type 3 diabetes taking metformin. Diabetes Care 2014;37:2141-8 and Rosenstock J, Fonseca VA, Grass JL et al. Advancing basal insulin replacement in type 2 diabetes inadequately controlled with insulin glargine plus oral agents: a comparison of adding albiglutide, a weekly GLP-1 receptor agonist, versus thrice-daily prandial in...
Source: Expert Review of Endocrinology and Metabolism - October 12, 2018 Category: Endocrinology Tags: Expert Rev Endocrinol Metab Source Type: research
PEGylated insulin Lispro (LY2605541): clinical overview of a new long-acting basal insulin analog in the treatment of Type 2 diabetes mellitus.
Authors: Røder ME
Abstract
Neutral Protamine Hagedorn insulin with an intermediate action profile has been in use for many years for the treatment of Type 1 diabetes and as an option for Type 2 diabetes. It is efficacious in reducing blood sugars, but shows substantial variability and risk of hypoglycemia. Basal insulin analogs have been developed in recent years to overcome these issues. Three basal insulin analogs are currently in the market in Europe. PEGylated insulin lispro is a new second-generation basal insulin analog which most likely will undergo review in 2016 by the US FDA and EMA in Europe fo...
Source: Expert Review of Endocrinology and Metabolism - October 11, 2018 Category: Endocrinology Tags: Expert Rev Endocrinol Metab Source Type: research
Male Patients with Longstanding Type 2 Diabetes Have a Higher Incidence of Hypoglycemia Compared with Female Patients
ConclusionMale patients with longstanding T2D had a higher incidence of hypoglycemia than female patients during intensive insulin therapy.Trial registrationClinicalTrials.gov identifier, ChiCTR-IPR-15007340. (Source: Diabetes Therapy)
Source: Diabetes Therapy - October 1, 2018 Category: Endocrinology Source Type: research
