Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar Insulin N with US-licensed Humulin® N formulation in healthy subjects: Results from the RHINE-2 (Recombinant Human INsulin Equivalence-2) study. To establish the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of proposed biosimilar Insulin N (Biocon's Insulin-N) and US-licensed Humulin® N (Humulin-N; Eli Lilly and Company, IN) in healthy subjects. This was a phase-1, single-center, double-blind, randomized, three-period, six-sequence, partially replicated, crossover, 24-h euglycemic clamp study. Overall, 90 healthy subjects were randomized, of whom 85 completed the study. The subjects received either two single doses of Biocon's Insulin-N and a single dose of Humulin-N or two single doses of Humulin-N
Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar Insulin-R with the US-licensed Humulin® R formulation in healthy subjects: Results from the RHINE-1 (Recombinant Human INsulin Equivalence-1) study. To establish equivalence in the pharmacokinetic (PK) and pharmacodynamic (PD) endpoints between proposed biosimilar Insulin-R (Biocon's Insulin-R) and Humulin® R using the euglycaemic clamp technique in healthy subjects. In this phase-1 automated euglycaemic glucose clamp study, 42 healthy subjects were randomized (1:1) to receive a single dose of 0.3 IU/kg of Biocon's Insulin-R and Humulin-R. Plasma insulin concentrations and glucose infusion rates (GIRs) were assessed over 12 hours. Primary PK endpoints were area under the insulin concentration-time curve from 0 to 12 hours
Pharmacokinetic and pharmacodynamic equivalence of Biocon's biosimilar Insulin 70/30 with US-licensed HUMULIN® 70/30 formulation in healthy subjects: Results from the RHINE-3 (Recombinant Human INsulin Equivalence-3) study. To establish the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of proposed biosimilar insulin 70/30 (Biocon's Insulin-70/30) and HUMULIN® 70/30 (HUMULIN-70/30 ; Eli Lilly and Company, IN). In this phase 1, automated euglycaemic glucose clamp study, 78 healthy subjects were randomized (1:1) to receive a single dose of 0.4 IU/kg of Biocon's Insulin-70/30 and HUMULIN-70/30. Plasma insulin concentrations and glucose infusion rates (GIRs) were assessed over 24 hours. Primary PK endpoints were area under the insulin concentration-time curve from 0 to 24 hours
Comparison of the Pharmacokinetic and Pharmacodynamic Properties of Biocon's Insulin R U-500 With Humulin® R U-500 (US Reference Product) in Healthy Subjects Single-centre, randomised, double-blind, three-period, six-sequence, partially replicated design, crossover trial in healthy subjects The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence of Biocon's
The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors. Competing interests VJ is listed as a contributor to the expert consultations on the report of the Standing National Committee on Medicines for the revision of National List of Essential Medicines. VJ has received grant funding from GSK, Baxter Healthcare, and Biocon
by non-invasive methods. Before SPA is tried, ultrasound guidance should be used to show that urine is in the bladder. NICE is aware of the following CE-marked devices that appear to fulfil a similar function to the BladderScan BVI 9400: • Bardscan II (Mediwatch [UK]) • Cubescan BioCon-500 and BioCon-700 (Medline) • SonoSite M-Turbo (FUJIFILM SonoSite). Costs and use of the technology Costs and use
. Manufacturing was then transferred from Archemis to Biocon Limited, India as Archemis ceased the production of masitinib mesylate. Two current manufacturers were initially proposed for the commercial scale manufacture of masitinib mesylate: Biocon Limited, India and Excella GmbH, Germany. The Biocon batches were used for some phase 2 and then phase 3 studies while Excella batches were used for phase 3 studies . Full information of masitinib mesylate manufacture and control was submitted in section 3.2.S.3 to support the quality of Biocon as a manufacture of the active substance. The applicant removed this source from the marketing authorisation application after the Day 120 List of Questions adopted by CHMP. An ASMF for masitinib mesylate was submitted by Excella GmbH for masitinib mesylate. A letter
Evaluation of Pharmacokinetics , Safety, Tolerability and Pharmacodynamics of Biocon Insulin Tregopil Multi-centre, open label, multiple ascending dose trial in patients with type 1 diabetes mellitus This is a Phase 1, open-label, multiple dose trial with two parts in patients with type 1 diabetes mellitus (T1DM). Part 1 consists of four cohorts with multiple ascending doses of insulin Tregopil
Comparision of Pharmacokinetics(PK) and Pharmacodynamics(PD) of Biocon Insulin R and Humulin® R Single-centre, randomised, double-blind, single dose, two-treatment, two-period, two sequence, crossover,12-hour euglycaemic glucose clamp trial in healthy subjects The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence of Biocon Insulin R with Humulin® R
Comparision of Pharmacokinetic and Pharmacodynamic of Biocon Insulin N and Humulin® N Single-centre, randomised, double-blind, three-period, six-sequence, partially replicated design, crossover trial in healthy subjects The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence of Biocon Insulin N with Humulin® N in healthy subjects.The treatment consists of one
Comparison of Pharmacokinetic (PK) and Pharmacodynamic(PD) of Biocon Insulin 70/30 and Humulin® 70/30 Two-centre, randomised, double-blind, single dose, two-treatment, two-period, two sequence, crossover, 24-hour euglycaemic glucose clamp trial in healthy subjects. The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence of Biocon Insulin 70/30 with Humulin® 70
, Biocon-700, to measure bladder volume in women postpartum. Fifty women were included in this method comparison study. Within 48 h of giving birth, their bladder volume was measured in randomized order with both transabdominal ultrasound and Biocon-700. After urination, participants were scanned with Biocon-700 to measure residual bladder volume, and finally the bladder was emptied by catheterization . The total bladder volume was calculated as the voided volume plus the catheterized volume. Biocon-700 measured 43.4 ml ± 117.4 ml (mean ± SD) lower than the total bladder volume, while volumes measured by transabdominal ultrasound were 117.8 ml ± 110.0 ml (mean ± SD) lower. Linear regression showed significant proportional bias in both methods. The Biocon-700 could detect a residual bladder volume > 150
in the form of the innovator product CellCept (F. Hoffmann-La Roche Ltd.) or one of three commercially available generics, Renodapt (Biocon Ltd.), Mycept (Panacea Biotec), or Cellmune (Cipla Ltd.). The study was powered to detect a 20% difference in mean formulation performance measures, but not to formally evaluate bioequivalence. Geometric mean ratios of maximum concentrations (C) and areas under plasma
to be developed for the growth and accessibility of caring public health systems. Achieving this will require an unprecedented joint effort on the part of government and civil societies.Vithika Pande is a student on an e-learning in public health management (ePHM) course at the Institute of Public Health, Bangalore. She is currently a project officer, women and child health, at the Biocon Foundation
the position of the bladder wall.The objective of the study is to assess the validity of existing pediatric algorithms for diagnosing neurogenic bladder and evaluate the accuracy of measuring the post-void residual volume between the ages of 0 to 6 years old.It hypothesizes that when the portable bladder scanner (Bladder Scanner, Biocon-900) is used in pediatric population between the ages of 0 to 3 years