Biomarkers have the potential to expedite drug development, increase patient safety, and optimize clinical response. Yet few have achieved regulatory qualification. A survey was conducted to clarify industry's perspective on biomarker qualification and identify the most promising biomarkers for drug development. The results across toxicities/clinical areas highlight challenges in regulatory qua...

‎In this paper, using the idea of convexificators, we study boundedness and nonemptiness of Lagrange multipliers satisfying the first order necessary conditions. We consider a class of nons- mooth fractional programming problems with equality, inequality constraints and an arbitrary set constraint. Within this context, define generalized Mangasarian-Fromovitz constraint qualification and sh...

Dual characterizations of the containment of a convex set with quasiconvex inequality constraints are investigated. A new Lagrange-type duality and a new closed cone constraint qualification are described, and it is shown that this constraint qualification is the weakest constraint qualification for the duality.

Most developed countries have already accepted‘’ Competency’’ as the major factor in making management more competitive, therefore they have discovered the importance of Qualification Models and their application to cause human resources growth. Consequently, their aim is to improve the qualification of their human resources, and to reach this end, considering different ways of assessing compet...

We considered that a query of this year’s Genomics track consists of two parts, target and qualification. A target refers to any instance of a certain entity type and the qualification refers to the condition that the target needs to satisfy in order to be qualified as an answer to the query. For example, the target and qualification of the query “What [ANTIBODIES] have been used to detect prot...

Contents Software Productivity Consortium (Consortium) members applying the tools for both the requirement and design model-driven verification and validation are often required to certify their software with various certification authorities such as the Federal Aviation Administration (FAA) and Food and Drug Administration (FDA). These certifications require methods and supporting artifacts fo...

Abbreviations: BSA: Bovine Serum Albumin; HABA: 4’-Hydroxyazo-Benzene-2-Carboxylic Acid; IQ: Installation Qualification; LIMS: Laboratory Information Management System; MRD: Minimum Required Dilution; OQ: Operational Qualification; PBS: Phosphate-Buffered Saline; PBST: Phosphate-Buffered Saline With 0.01% Tween-20; PEG: Polyethylene Glycol; PK: Pharmacokinetics; PMT: Photomultiplier-Tube; PQ: P...

This study explores the regulatory basis and applied aspects of qualification centers in Ukraine, focusing on their role recognizing professional qualifications addressing gaps. The establishment is grounded Ukrainian legislation, with main responsibility awarding through validation non-formal informal learning based occupational standards. center accreditation process overseen by National Qual...

Tool classification is an important part of the tool qualification process required by ISO 26262 since it determines the required confidence level for each tool in use. To cover the variety of tools used by practitioners, the standard only provides a framework for tool classification and leaves it up to the applicant to instantiate this framework. To illustrate the ISO 26262 tool classification...