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.

scholarly journals Modern Trends in Analytical Techniques for Method Development and Validation of Pharmaceuticals: A Review

2021 ◽  
Vol 11 (1-s) ◽  
pp. 121-130
Author(s):  
Shivani Sharma ◽  
Navdeep Singh ◽  
Amar Deep Ankalgi ◽  
Arti Rana ◽  
Mahendra Singh Ashawat
Keyword(s):  
Analytical Chemistry ◽  
Drug Development ◽  
Development Process ◽  
Method Development ◽  
Limit Of Detection ◽  
Analytical Techniques ◽  
Review Article ◽  
Modern Trend ◽  
Method Development And Validation ◽  
Development And Validation

The process of drug development requires a suitable technique which helps the scientist to analyze the drug molecule is an accurate, precise, and easiest way. For the quantitative and qualitative estimation of drugs in analytical chemistry it is very important to identify the best method for method development.  This study helps the author to understand the various analytical techniques available for the process of drug development which includes spectroscopy, chromatography, electrochemical techniques, electrophoretic, flow injection analysis, and hyphenated technique. All these methods contain different analytical process with a variety of separate techniques. Also, we discuss about the modern trend which are available, and implacable in all these methods to improve the analytical behavior of these techniques. In method development process the validation of document must be required in the form of accuracy, precision, specificity, limit of detection, linearity, and range is considered. So, this review article contains the brief summary of available analytical techniques, and the latest trend in method development, or the process of method validation, and development of method. The discussed methods in this review article were revealed by the scientist, and these techniques must require in new drug development process, which helps the person to utilize the potential of these techniques. Trend in the analytical chemistry to overcome the error in method development was necessary, and the latest trends in method development technique were useful to defeat errors in analytical techniques. Keywords: Analytical techniques, Modern trends, Process of method development, and validation.

Intelligent Drug Development

2014 ◽  
Author(s):  
Michael Tansey
Keyword(s):  
Clinical Trials ◽  
Cost Effectiveness ◽  
Drug Development ◽  
Clinical Research ◽  
Development Process ◽  
Drug Development Process ◽  
Individual Trial ◽  
Specific Technology

Clinical research is heavily regulated and involves coordination of numerous pharmaceutical-related disciplines. Each individual trial involves contractual, regulatory, and ethics approval at each site and in each country. Clinical trials have become so complex and government requirements so stringent that researchers often approach trials too cautiously, convinced that the process is bound to be insurmountably complicated and riddled with roadblocks. A step back is needed, an objective examination of the drug development process as a whole, and recommendations made for streamlining the process at all stages. With Intelligent Drug Development, Michael Tansey systematically addresses the key elements that affect the quality, timeliness, and cost-effectiveness of the drug-development process, and identifies steps that can be adjusted and made more efficient. Tansey uses his own experiences conducting clinical trials to create a guide that provides flexible, adaptable ways of implementing the necessary processes of development. Moreover, the processes described in the book are not dependent either on a particular company structure or on any specific technology; thus, Tansey's approach can be implemented at any company, regardless of size. The book includes specific examples that illustrate some of the ways in which the principles can be applied, as well as suggestions for providing a better context in which the changes can be implemented. The protocols for drug development and clinical research have grown increasingly complex in recent years, making Intelligent Drug Development a needed examination of the pharmaceutical process.

scholarly journals Bayesian meta-analytical methods to incorporate multiple surrogate endpoints in drug development process

2015 ◽  
Vol 35 (7) ◽  
pp. 1063-1089 ◽  
Author(s):  
Sylwia Bujkiewicz ◽  
John R. Thompson ◽  
Richard D. Riley ◽  
Keith R. Abrams
Keyword(s):  
Drug Development ◽  
Analytical Methods ◽  
Development Process ◽  
Surrogate Endpoints ◽  
Drug Development Process

scholarly journals Precision Medicine: From “Omics” to Economics towards Data-Driven Healthcare - Time for European Transformation

2017 ◽  
Vol 2 (Suppl. 1) ◽  
pp. 1-10 ◽  
Author(s):  
Denis Lacombe ◽  
Lifang Liu ◽  
Françoise Meunier ◽  
Vassilis Golfinopoulos
Keyword(s):  
Drug Development ◽  
Development Process ◽  
Precision Oncology ◽  
Drug Development Process ◽  
Cancer Treatments ◽  
True Value ◽  
Efficient Access ◽  
Funding Agencies ◽  
Anti Cancer

There is room for improvement for optimally bringing the latest science to the patient while taking into account patient priorities such as quality of life. Too often, regulatory agencies, governments, and funding agencies do not stimulate the integration of research into care and vice versa. Re-engineering the drug development process is a priority, and healthcare systems are long due for transformation. On one hand, patients need efficient access to treatments, but despite precision oncology approaches, efficiently shared screening platforms for sorting patients based on the biology of their tumour for trial access are lacking and, on the other hand, the true value of cancer care is poorly addressed as central questions such as dose, scheduling, duration, and combination are not or sub-optimally addressed by registration trials. Solid evidence on those parameters could potentially lead to a rational and wiser use of anti-cancer treatments. Together, optimally targeting patient population and robust comparative effectiveness data could lead to more affordable and economically sound approaches. The drug development process and healthcare models need to be interconnected through redesigned systems taking into account the full math from drug development into affordable care.

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