The method history report: an adaptable tool for communicating immunogenicity assay development and validation

Bioanalysis ◽  
2020 ◽  
Vol 12 (22) ◽  
pp. 1597-1605
Author(s):  
Kristin Hollister ◽  
Huy T Nguyen ◽  
Jessie L Bishop ◽  
Jeff W Cramer ◽  
Nicoletta Bivi ◽  
...  
Keyword(s):  
Review Process ◽  
Assay Development ◽  
General Outline ◽  
Therapeutic Program ◽  
Biologics License Application ◽  
License Application ◽  
History Of ◽  
Development And Validation ◽  
Information Requests ◽  
Immunogenicity Assay

Over the developmental lifetime of a therapeutic protein, the immunogenicity assay validation history can become substantial, frustrating review of clinical immunogenicity within the biologics license application. In our experience, this can lead to questions by regulators, resulting in numerous information requests during the review process. To address this, we propose a new document, the method history report (MHR), which can comprehensively present the history of the immunogenicity assay for regulators, including assay development and validation. The flexibility of the MHR allows for adaptation to the specific needs of each therapeutic program, while maintaining a consistent template. Here, we detail the rationale, general outline and template for the MHR and recommend others consider adopting it for their biologics license application-related activities.

scholarly journals Immunogenicity assay development and validation for biological therapy as exemplified by ustekinumab

2019 ◽  
Vol 196 (2) ◽  
pp. 259-275 ◽  
Author(s):  
S. Mojtahed Poor ◽  
T. Ulshöfer ◽  
L. A. Gabriel ◽  
M. Henke ◽  
M. Köhm ◽  
...  
Keyword(s):  
Biological Therapy ◽  
Assay Development ◽  
Development And Validation ◽  
Immunogenicity Assay

XIV. Researches into the molecular constitution of the organic bases

1851 ◽  
Vol 141 ◽  
pp. 357-398 ◽  
Keyword(s):  
Physical Properties ◽  
Royal Society ◽  
General Outline ◽  
Organic Bases ◽  
History Of ◽  
The Subject ◽  
Molecular Constitution

About twelve months ago I had the honour of presenting to the Royal Society an account of a series of researches into the molecular constitution of the volatile organic bases: at present I beg to submit to the consideration of the Society the history of a new group of alkaloids, which, although intimately connected with the former by their origin, differ from them altogether by their properties, and especially in not being volatile . The members of this new group of alkaloids are so numerous, their deportment is so singular, and their derivatives ramify in so many directions, that I have not as yet been able to complete the study of these substances in all their bearings; nor is it my intention to go fully into the chemistry of the subject in the present com­munication, my object being merely to establish the existence of these bodies, and to give a general outline of their connection with the volatile bases, and of their most prominent chemical and physical properties, reserving a detailed description of their salts and derivatives to a future memoir.

scholarly journals Development and validation of a motivational persistence scale

Psihologija ◽  
2012 ◽  
Vol 45 (2) ◽  
pp. 99-120 ◽  
Author(s):  
Ticu Constantin ◽  
Andrei Holman ◽  
Maria Hojbotă
Keyword(s):  
Factor Analysis ◽  
Self Report ◽  
Divergent Validity ◽  
Canonical Correlations ◽  
Confirmatory Factor ◽  
Specific Goal ◽  
Convergent And Divergent Validity ◽  
History Of ◽  
Development And Validation

The main goal of our research was to develop a new measure of persistence and to assess its construct validity and psychometric proprieties. First, we discuss the history of the psychological construct of persistence, defined here as the tendency to remain engaged in specific goal-related activities, despite difficulties, obstacles, fatigue, prolonged frustration or low perceived feasibility. The developed scale, measuring motivational persistence, contains three-factors: long-term purposes pursuing, current purposes pursuing and recurrence of unattained purposes. The results of the two validation studies conducted, employing both exploratory and confirmatory factor analysis, advocate the hypothesized structure. Also, the Pearson and canonical correlations between the three factors of the new self-report scale and other three related measures (and their factors) indicate good levels of convergent and divergent validity of the new scale.

Bacillus Stearothermophilus Disc Assay: A Review

1995 ◽  
Vol 78 (6) ◽  
pp. 1408-1415
Author(s):  
Stanley E Katz ◽  
Marie Siewierski
Keyword(s):  
Bacillus Stearothermophilus ◽  
Assay Development ◽  
The Future ◽  
Development Data ◽  
History Of ◽  
Disc Assay

Abstract The literature on the Bacillus stearothermophilus disc assay was reviewed and evaluated. The history of the assay development; data on applicability, sensitivity, interferences, and cowside screening; potential for the future; and limitations are presented and discussed.

Update to the European Bioanalysis Forum recommendation on biomarkers assays; bringing context of use into practice

Bioanalysis ◽  
2020 ◽  
Vol 12 (20) ◽  
pp. 1427-1437
Author(s):  
Joanne Goodman ◽  
Kyra J Cowan ◽  
Michaela Golob ◽  
Lars Karlsson ◽  
Ulrich Kunz ◽  
...  
Keyword(s):  
Drug Development ◽  
Development Process ◽  
Method Development ◽  
Assay Development ◽  
Drug Development Process ◽  
Validation Criteria ◽  
Context Of Use ◽  
The Right ◽  
Development And Validation ◽  
Correct Data

In 2012, the European Bioanalysis Forum published a recommendation on biomarker method development and the bioanalysis of biomarkers in support of drug development. Since then, there has been significant discussion on how to bring the topic of context of use of biomarker assays to the forefront so that the purpose of the assay, the use of the data and the decisions being made with the data are well defined and clearly understood, not just by the bioanalytical scientist, but across all stakeholders. Therefore, it is imperative that discussions between the bioanalytical laboratory and the end users of the data happen early (and regularly) in the drug development process to enable the right assays to be developed and appropriately validated to generate the correct data and allow suitable decisions to be made. This updated refinement to the previous European Bioanalysis Forum recommendation will highlight the items to consider when discussing context of use for biomarker assay development and validation, thus enabling the correct conversations to occur and the move away from the misapplication of PK assay validation criteria to biomarker assays.

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