scholarly journals Similarity assessment of quality attributes of biological medicines: the calculation of operating characteristics to compare different statistical approaches

AAPS Open ◽  
2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Thomas Stangler ◽  
Martin Schiestl
Keyword(s):  
Decision Making ◽  
Statistical Approach ◽  
Quality Attributes ◽  
Error Rates ◽  
Operating Characteristics ◽  
Regulatory Decision ◽  
Statistical Approaches ◽  
False Acceptance ◽  
False Rejection ◽  
Rejection Rates

Abstract The comparison of quality attributes is a key element in the evaluation of both biosimilars and manufacturing process changes for biological medicines. Different statistical approaches are proposed to facilitate such evaluations. However, there is no regulatory consensus on a quantitative and scientifically justified definition and an underlying hypothesis of a statistically equivalent quality. The latter is essential to calculate operating characteristics of different approaches. This article proposes a hypothesis for establishing statistically equivalent quality which is concordant with current regulations. It also describes a tool which allows comparisons of different statistical approaches or tests by calculating the operating characteristics for false acceptance and false rejection rates of a claim for statistically equivalent quality. These error rates should be as low as possible to allow a meaningful application of a statistical approach in regulatory decision making. The described tool can be used to compare different statistical approaches for their suitability and may also facilitate the discussion and development of statistical approaches for comparing quality attributes in similarity assessments in general.

scholarly journals How to Protect Patients Digital Images/Thermograms Stored on a Local Workstation

10.14311/1305 ◽  
2010 ◽  
Vol 50 (6) ◽  
Author(s):  
J. Živčák ◽  
M. Roško
Keyword(s):  
Reliable Method ◽  
Medical Information ◽  
Digital Images ◽  
Personal Identification ◽  
Security And Privacy ◽  
Acceptance Rates ◽  
False Acceptance ◽  
False Rejection ◽  
Rejection Rates

To ensure the security and privacy of patient electronic medical information stored on local workstations in doctors’ offices, clinic centers, etc., it is necessary to implement a secure and reliable method for logging on and accessing this information. Biometrically-based identification technologies use measurable personal properties (physiological or behavioral) such as a fingerprint in order to identify or verify a person’s identity, and provide the foundation for highly secure personal identification, verification and/or authentication solutions. The use of biometric devices (fingerprint readers) is an easy and secure way to log on to the system. We have provided practical tests on HP notebooks that have the fingerprint reader integrated. Successful/failed logons have been monitored and analyzed, and calculations have been made. This paper presents the false rejection rates, false acceptance rates and failure to acquire rates.

scholarly journals Just look at to open it up:

2021 ◽  
Author(s):  
Maciej Smiatacz ◽  
Bogdan Wiszniewski
Keyword(s):  
Fine Tuning ◽  
Identity Verification ◽  
Password Authentication ◽  
Electronic Documents ◽  
Facial Identity ◽  
Biometric Verification ◽  
Verification Techniques ◽  
False Acceptance ◽  
False Rejection ◽  
Rejection Rates

AbstractElectronic documents constitute specific units of information, and protecting them against unauthorized access is a challenging task. This is because a password protected document may be stolen from its host computer or intercepted while on transfer and exposed to unlimited offline attacks. The key issue is, therefore, making document passwords hard to crack. We propose to augment a common text password authentication interface to encrypted documents with a biometric facial identity verification providing highly personalized security mechanism based on pseudo-identities. In consequence the encrypted document can be unlocked with the legitimate user’s face, while for everyone else stays encrypted with a hard to crack text password. This paper makes two contributions: (1) The proposed scheme enables password autofill without referring to any external service, which significantly limits the possibilities of an attack by adversaries when opening, reading and editing the protected document, (2) By the adoption of biometric verification techniques enabling fine-tuning of false acceptance and false rejection rates, it provides for responsible adaptation to users.

Optical Scanning for Large-Scale Studies

1975 ◽  
Vol 14 (01) ◽  
pp. 32-34
Author(s):  
Elisabeth Schach
Keyword(s):  
Large Scale ◽  
Error Rates ◽  
Data Reporting ◽  
Reading Error ◽  
Optical Scanning ◽  
Rejection Rates

Data reporting the experience with an optical mark page reader is presented (IBM 1231Ν1). Information from 52,000 persons was gathered in seven countries, decentrally coded and centrally processed. Reader performance rates (i.e. sheets read per hour, sheet rejection rates, reading error rates) and costs (coding, verification, reading, etc.) are given.

Voluntary food fortification policy in Australia: did ‘formal’ stakeholder consultation influence the outcome?

2021 ◽  
Author(s):  
Bronwyn Ashton ◽  
Cassandra Star ◽  
Mark Lawrence ◽  
John Coveney
Keyword(s):  
Public Health ◽  
Decision Making ◽  
Policy Process ◽  
Policy Development ◽  
Food Fortification ◽  
Policy Debate ◽  
Stakeholder Consultation ◽  
Regulatory Decision ◽  
Food Regulation ◽  
Ministerial Council

Summary This research aimed to understand how the policy was represented as a ‘problem’ in food regulatory decision-making in Australia, and the implications for public health nutrition engagement with policy development processes. Bacchi’s ‘what’s the problem represented to be?’ discourse analysis method was applied to a case study of voluntary food fortification policy (VFP) developed by the then Australia and New Zealand Food Regulation Ministerial Council (ANZFRMC) between 2002 and 2012. As a consultative process is a legislated aspect of food regulatory policy development in Australia, written stakeholder submissions contributed most of the key documents ascertained as relevant to the case. Four major categories of stakeholder were identified in the data; citizen, public health, government and industry. Predictably, citizen, government and public health stakeholders primarily represented voluntary food fortification (VF) as a problem of public health, while industry stakeholders represented it as a problem of commercial benefit. This reflected expected differences regarding decision-making control and power over regulatory activity. However, at both the outset and conclusion of the policy process, the ANZFRMC represented the problem of VF as commercial benefit, suggesting that in this case, a period of ‘formal’ stakeholder consultation did not alter the outcome. This research indicates that in VFP, the policy debate was fought and won at the initial framing of the problem in the earliest stages of the policy process. Consequently, if public health nutritionists leave their participation in the process until formal consultation stages, the opportunity to influence policy may already be lost.

Real‐world evidence to support regulatory decision making: New or expanded medical product indications

2021 ◽  
Author(s):  
Jessica M. Franklin ◽  
Kai‐Li Liaw ◽  
Solomon Iyasu ◽  
Cathy Critchlow ◽  
Nancy Dreyer
Keyword(s):  
Decision Making ◽  
Real World ◽  
Medical Product ◽  
Regulatory Decision ◽  
Real World Evidence

Adults with Autism Show Increased Sensitivity to Outcomes at Low Error Rates During Decision-Making

2006 ◽  
Vol 37 (7) ◽  
pp. 1279-1288 ◽  
Author(s):  
Arpi Minassian ◽  
Martin Paulus ◽  
Alan Lincoln ◽  
William Perry
Keyword(s):  
Decision Making ◽  
Error Rates ◽  
Adults With Autism ◽  
Increased Sensitivity

Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy

2015 ◽  
Vol 98 (5) ◽  
pp. 502-505 ◽  
Author(s):  
A Segec ◽  
B Keller-Stanislawski ◽  
NS Vermeer ◽  
C Macchiarulo ◽  
SM Straus ◽  
...  
Keyword(s):  
Decision Making ◽  
Progressive Multifocal Leukoencephalopathy ◽  
Regulatory Decision
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