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Briggs R.J.,Eurofins | Nicholson R.,PPD Inc | Vazvaei F.,Roche Holding AG | Busch J.,Pfizer | And 8 more authors.
Botanical Review | Year: 2014

This paper presents the recommendations of the Global Bioanalytical Consortium Harmonization Team on method transfer, partial validation, and cross validation. These aspects of bioanalytical method validation, while important, have received little detailed attention in recent years. The team has attempted to define, separate, and describe these related activities, and present practical guidance in how to apply these techniques. © 2014, American Association of Pharmaceutical Scientists. Source


Pranesh G.T.,Clinigene International Ltd | Faith M.,Christian Medical College
Journal of Association of Physicians of India | Year: 2014

Objectives: This study is aimed at evaluating the degree of standardisation of HbA1c and glucose testing across accredited laboratories in India. Methods: The information declared on the scope of testing by 147 medical laboratories accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL) across India was used by the authors for this study (http://www.nabl-india.org). This information on the scope of testing is available within the public domain and is accessible through the NABL website and covered laboratories accredited between 2009 and 2012. We focussed on HbA1c and glucose tests offered by laboratories and documented the way tests were named, the methodologies used and the degree of confidence in testing based on the coefficient of variation (CV). The data was independently reviewed by two medical biochemists and then subjected to analysis. Results: Although the glucose test appeared to be ubiquitous, HbA1c assays appeared on the scope of testing in 87.1% of the laboratories. The HbA1c tests however appear to be poorly standardised across laboratories. We noted gross differences in test nomenclature, methodology and analytical performance across laboratories. Conclusion: This is one of the first studies that has focussed on the standards of laboratory care for diabetes management in India. The study highlights the lack of standardisation in nomenclature, analytical performance and methodology of tests used for HbA1c in NABL accredited laboratories across India. Affirmative actions in terms of improved regulation, patient advocacy, further studies on impact of laboratory quality and education of physicians, healthcare providers, laboratorians may improve harmonisation and quality of patient care in diabetes in India. © JAPI. Source


Marini J.C.,Janssen Research and Development LLC | Anderson M.,BDS Immunoassay Services | Cai X.-Y.,Merck Ltd. | Chappell J.,CPR Pharma Services Pty Ltd | And 7 more authors.
Botanical Review | Year: 2014

For biosimilar drug development, it is critical to demonstrate similar physiochemical characteristics, efficacy, and safety of the biosimilar product compared to the reference product. Therefore, pharmacokinetic (PK) and immunogenicity (antidrug antibody, ADA) assays that allow for the demonstration of biosimilarity are critical. Under the auspices of the American Association of Pharmaceutical Scientists (AAPS) Ligand-Binding Assay Bioanalytical Focus Group (LBABFG), a Biosimilars Action Program Committee (APC) was formed in 2011. The goals of this Biosimilars APC were to provide a forum for in-depth discussions on issues surrounding the development and validation of PK and immunogenicity assays in support of biosimilar drug development and to make recommendations thereof. The Biosimilars APC’s recommendations for the development and validation of ligand-binding assays (LBAs) to support the PK assessments for biosimilar drug development are presented here. Analytical recommendations for the development and validation of LBAs to support immunogenicity assessments will be the subject of a separate white paper. © 2014, American Association of Pharmaceutical Scientists. Source


Khedkar A.,Biocon | Iyer H.,Biocon | Anand A.,Biocon | Verma M.,Biocon | And 3 more authors.
Diabetes, Obesity and Metabolism | Year: 2010

Aim: The objective of the study was to establish the dose response of IN-105 tablets and explore a possible therapeutic window in type 2 diabetes subjects poorly controlled on metformin. Methods: The primary objective was to examine the effect of sequential single ascending doses of IN-105 on the plasma glucose concentration under fed conditions. All subjects received, sequentially, matching placebo, 10, 15, 20 and 30 mg IN-105 tablets in five consecutive periods. Tablets were administered 20 min prior to meal in all the periods. Plasma levels of immunoreactive insulin, C-peptide and glucose were measured up to 180 min from the time of dosing. The changes in postprandial glucose levels at 120 min in response to IN-105 administration were also compared against those of placebo. Results: Changes in glucose from baseline (mean ± s.d.) at 140 min (2 h postprandial) were 94.84 ± 22.3, 79.45 ± 43.00, 70.68 ± 35.71, 63.47 ± 42.75 and 53.06 ± 47.27 mg/dL, respectively, and exhibited linear dose-response. The insulin Cmax values were found to be 50.8 ± 26.0 mU/L for placebo, 100.3 ± 66.7 with 10 mg IN-105, 177.69 ± 150.3 with 15 mg IN-105, 246.2 ± 245.2 with 20 mg IN-105 and 352.5 ± 279.3 mU/L with 30 mg of IN-105. Conclusions: IN-105 absorption is proportional to the dose administered. The 2-h postprandial glucose excursion was reduced in a dose proportional manner. Circulating C-peptide levels were found to be suppressed in proportion to the IN-105 exposure. IN-105 reduces glucose excursion despite lower endogenous insulin secretion. IN-105 seems to have a wide therapeutic window as no clinical hypoglycaemia was observed at any of the doses studied. © 2010 Blackwell Publishing Ltd. Source


Basavaraj C.,Clinigene International Ltd | Shivu J.,Clinigene International Ltd | Melarkode R.,Biocon | Nair P.,Biocon
Cancer Biology and Therapy | Year: 2010

Head and neck cancer associated with the chewing of betel preparations, including tobacco, is common to South East asia. We report a Phase IIB study in which ninety-two treatment naïve patients with advanced squamous cell carcinoma received standard therapy with or without an anti-Epidermal Growth Factor Receptor (EGFR) monoclonal antibody (Nimotuzumab). In pretreatment samples, the tissue expression of ErbB family proteins and downstream molecules, including their association with clinical response and survival. Marker expression in tumor adjacent sections was evaluated by immunohistochemistry. The clinical benefit of Nimotuzumab (200 mg/dose, once a week for six weeks) in combination with radiotherapy or chemoradiation was assessed with respect to EGFR expression and intensity. Two antibodies, which recognized independent epitopes, were used to assess EGFR expression levels by immunohistochemistry. EGFR detection using mR3, an antibody with similar specificity to Nimotuzumab, correlated significantly with the expression of ErbB3 (p < 0.05), PCNA and pMAPK (p < 0.001). Although EGFR expression showed a significant relationship to patient survival in patients treated with Nimotuzumab and chemoradiation (p=0.02), pMAPK expression did not (p=0.07). Interestingly, EGFR overexpression (as defined by mR3) correlated directly with overall survival in this group (p=0.01). this data supports a model of basal activation of the EGFR signal transduction pathway in these oropharyngeal tumors. Detection of EGFR by immunohistochemistry could define a subset of treatment naïve Head and Neck cancer patients who may benefit from receiving EGFR targeted therapies in combination with chemoradiation. © 2010 landes Bioscience. Source

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