The effectiveness of quality control samples in pharmaceutical bioanalysis

Bioanalysis ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 135-145
Author(s):  
Stephen Keller ◽  
Jorge Quiroz ◽  
Dave Christopher ◽  
Enaksha Wickremsinhe ◽  
Wanping Geng ◽  
...  
Keyword(s):  
Quality Control ◽  
Systematic Evaluation ◽  
Pharmacokinetic Data ◽  
Concentration Data ◽  
Pharmaceutical Development ◽  
Regulatory Guidance ◽  
Leadership Group ◽  
Continued Use ◽  
Analytical Platforms

The use of quality control (QC) samples in bioanalysis is well established and consistent with regulatory guidance. However, a systematic evaluation of whether QC samples serve the intended purpose of improving data quality has not been undertaken. The Translational and ADME Sciences Leadership Group (TALG) of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) conducted an evaluation to assess whether closer agreement is observed when comparing pharmacokinetic data from two passed runs, than when comparing data from failed and passed (retest) runs. Analysis of data collected across organizations, molecular types and analytical platforms, revealed that bioanalytical methods are very reproducible; and that QC samples improve the overall quality of pharmacokinetic concentration data and justifies their continued use.

Recommendations for singlet-based approach in ligand binding assays: an IQ Consortium perspective

Bioanalysis ◽  
2020 ◽  
Author(s):  
Renuka Pillutla ◽  
Boris Gorovits ◽  
Carol Gleason ◽  
Jorge Quiroz ◽  
David Christopher ◽  
...  
Keyword(s):  
Ligand Binding ◽  
Simulation Models ◽  
Study Quality ◽  
Binding Assays ◽  
Pharmaceutical Development ◽  
Drug Candidates ◽  
Leadership Group ◽  
The Impact ◽  
Analytical Platforms ◽  
Good Agreement

Historically, ligand-binding assays for pharmacokinetic samples employed duplicate rather than singlet-based analysis. Herein, the Translational and absorption, distribution, metabolism and excretion (ADME) Sciences Leadership Group of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) presents a study aiming to determine the value of duplicate versus singlet-based testing. Based on analysis of data collected from eight organizations for 20 drug candidates representing seven molecular types and four analytical platforms, statistical comparisons of validation and in-study quality controls and study unknown samples demonstrated good agreement across duplicate sets. Simulation models were also used to assess the impact of sample duplicate characteristics on bioequivalence outcomes. Results show that testing in singlet is acceptable for assays with % CV ≤15% between duplicates. Singlet-based approach is proposed as the default for ligand-binding assays while a duplicate-based approach is needed where imprecision and/or inaccuracy impede the validation of the assay.

Development and Application of Quality Control System for Highway Subgrade Construction

2019 ◽  
Vol 2 (5) ◽  
Author(s):  
Tong Wang
Keyword(s):  
Quality Control ◽  
Real Time ◽  
Detection Method ◽  
System Development ◽  
Effective Control ◽  
Construction Process ◽  
Development Mode ◽  
The Road ◽  
Whole Process

The compaction quality of the subgrade is directly related to the service life of the road. Effective control of the subgrade construction process is the key to ensuring the compaction quality of the subgrade. Therefore, real-time, comprehensive, rapid and accurate prediction of construction compaction quality through informatization detection method is an important guarantee for speeding up construction progress and ensuring subgrade compaction quality. Based on the function of the system, this paper puts forward the principle of system development and the development mode used in system development, and displays the development system in real-time to achieve the whole process control of subgrade construction quality.

Construction Control As A Strategy For Improving The Quality Of Buildings And Structures

2020 ◽  
Keyword(s):  
Quality Control ◽  
Life Cycle ◽  
Construction Control ◽  
Construction Sites ◽  
Actual Problem ◽  
Construction Market ◽  
Construction Products ◽  
Underlying Causes ◽  
Required Quality

In construction production, the safety of constructing buildings and structures is achieved by ensuring the required quality as a result of systematic construction control based on the implementation of a complex of technical, economic and organizational measures at all stages of the object's life cycle. The article deals with the actual problem of improving the quality of construction products-buildings and structures in conjunction with the activities of construction control bodies. The article presents the advanced foreign and domestic experience of ensuring the quality control at the construction sites, providing for the prevention of the underlying causes of defects and increasing the interest of the contractors directly. On the basis of the analysis of the current situation with quality control at the construction market, ways to improve its efficiency by developing a unified system of technological implementation of relevant requirements for the quality of construction products, determining the rational number and business load of construction control engineers, as well as the active activities of self-regulatory organizations in this area are offered.

68. The resident experience in a large urban teaching setting: Results of the 2005-2006 resident exit survey, University of Torontos

2007 ◽  
Vol 30 (4) ◽  
pp. 66
Author(s):  
N. Tenn-Lyn ◽  
S. Verma ◽  
R. Zulla
Keyword(s):  
Quality Control ◽  
Residency Training ◽  
Royal College ◽  
Online Survey ◽  
Career Guidance ◽  
Training Programs ◽  
Program Planning ◽  
Educational Experience ◽  
Care Experience

We developed and implemented an annual online survey to administer to residents exiting residency training in order to (1) assess the quality of the residency experience and (2) identify areas of strength and areas requiring improvement. Long-term goals include program planning, policy-making and maintenance of quality control. Survey content was developed from an environmental scan, pre-existing survey instruments, examination of training criteria established by the CFPC and the CanMEDS criteria established by the RCPSC. The survey included evaluation benchmarks and satisfaction ratings of program director and faculty, preparation for certification and practice, quality of life, quality of education, and work environment. The response rate was 28%. Seventy-five percent of respondents were exiting from Royal College training programs. Results of descriptive statistics determined that the overall educational experience was rated highly, with 98.9% of respondents satisfied or very satisfied with their overall patient care experience. Ninety-six percent of respondents were satisfied or very satisfied with the overall quality of teaching. Preparation for practice was identified as needing improvement, with 26% and 34% of respondents giving an unsatisfactory rating to career guidance and assistance with finding employment, respectively. Although 80% of respondents reported receiving ongoing feedback and 84% discussed their evaluations with their supervisors, only 38% of evaluations were completed by the end of the rotation. The results indicate that residents are generally satisfied with their experiences during residency training, especially with their overall educational experience. Areas of improvement include preparation for practice and timeliness of evaluations. Further iterations of this survey are needed to refine the instrument, identify data trends and maintain quality control in residency training programs. Frank JR (ed.). The CanMEDS competency framework: better standards, better physicians, better care. Ottawa: The Royal College of Physicians and Surgeons of Canada, 2005. Merritt, Hawkins and Associates. Summary Report: 2003 Survey of final-year medical residents. http://www.merritthawkins.com/pdf/MHA2003residentsurv.pdf. Accessed May 1, 2006. Regnier K, Kopelow M, Lane D, Alden A. Accreditation for learning and change: Quality and improvement as the outcome. The Journal of Continuing Education in the Health Professions 2005; 25:174-182.

System errors of manufacturers of medicines detected by conducting of state control in the area of circulation of medicines

2019 ◽  
Vol 2019 (5) ◽  
pp. 32-38
Author(s):  
Валентина Косенко ◽  
Valentina Kosenko ◽  
Алла Трапкова ◽  
Alla Trapkova ◽  
Светлана Тарасова ◽  
...  
Keyword(s):  
Quality Control ◽  
Quality Management ◽  
Management Systems ◽  
State Control ◽  
Quality Management Systems ◽  
Conducting State ◽  
Pharmaceutical Quality ◽  
State Quality ◽  
System Errors

The article conducts the analysis of system errors detected by Roszdravnadzor by conducting state quality control of circulating medicines, as well as weaknesses in pharmaceutical quality management systems of the manufacturers, that can influence the quality of manufactured drugs.

New Monitoring Strategy for the Quality Control in the Processing Practice of Scutellariae Radix

2020 ◽  
Vol 16 (3) ◽  
pp. 303-311
Author(s):  
Qi Huang ◽  
Chunsong Cheng ◽  
Lili Li ◽  
Daiyin Peng ◽  
Cun Zhang
Keyword(s):  
Quality Control ◽  
Monitoring Strategy ◽  
Scutellariae Radix ◽  
Chromatographic Fingerprints ◽  
New Strategy ◽  
Processed Products ◽  
Main Components ◽  
Processing Techniques ◽  
Multivariate Monitoring

Background: Scutellariae Radix (Huangqin) is commonly processed into 3 products for different clinical applications. However, a simple analytical method for quality control has rarely been reported to quickly estimate the degree of processing Huangqin or distinguish differently processed products or unqualified Huangqin products. Objective: To study a new strategy for quality control in the processing practice of Huangqin. Methods: Seven kinds of flavonoids that mainly exist in Huangqin were determined by HPLC-DAD. Chromatographic fingerprints were established to study the variation and discipline of the 3 processed products of Huangqin. PCA and OPLS-DA were used to classify differently processed products of Huangqin. Results: The results showed that baicalin and wogonoside were the main components in the crude and the alcohol Huangqin herb while baicalein and wogonin mainly existed in carbonized Huangqin. The results of mathematical statistics revealed that the processing techniques can make the quality of medicinal materials more uniform. Conclusion: This multivariate monitoring strategy is suitable for quality control in the processing of Huangqin.

DRUG REGULATORY PROCEDURES IN TANZANIA: A GLIMPSE

2015 ◽  
Vol 3 (2) ◽  
pp. 1-7 ◽  
Author(s):  
Achin Jain ◽  
M P Venkatesh M P ◽  
Pramod T.M. Kumar
Keyword(s):  
Quality Control ◽  
Medical Devices ◽  
Emerging Market ◽  
Well Being ◽  
New Drugs ◽  
Regulatory Body ◽  
Herbal Drugs ◽  
Drug Products ◽  
Set Up

In Tanzania, Tanzania Food and Drugs Authority (TFDA), is a regulatory body responsible for controlling the quality,safety and effectiveness of food, drugs, herbal drugs, cosmetics and medical devices. The Authority has been ensuringsafety, efficacy and quality of medicines by quality control tests; in addition to other quality assessment mechanisms.The guidelines laid by TFDA have also emanated from commitment to democracy and gives strong emphasis to thefulfilment of the needs of the less privileged rural population.Tanzania is an emerging market; the pharmaceutical market is valued at over US$250 million, and is growing at anannual rate of around 16.5% and is expected to reach approximately US$550 billion in 2020. Currently, the market ishighly dependent on imports, which account for around 75% of the total pharmaceutical market.The procedures and approval requirements of new drugs, variations, import, export and disposal have been set up bythe TFDA, which help in maintaining quality of the drug products that are imported as well being produced locally 

Animal Models and Alternatives in the Quality Control of Vaccines: Are In Vitro Methods or In Vivo Methods the Scientific Equivalent of the Emperor's New Clothes?

1995 ◽  
Vol 23 (1) ◽  
pp. 61-73
Author(s):  
Coenraad Hendriksen ◽  
Johan van der Gun
Keyword(s):  
Quality Control ◽  
Test Methods ◽  
In Vitro Test ◽  
Large Numbers ◽  
Alternative Approach ◽  
Inactivated Vaccines ◽  
Vitro Test

In the quality control of vaccine batches, the potency testing of inactivated vaccines is one of the areas requiring very large numbers of animals, which usually suffer significant distress as a result of the experimental procedures employed. This article deals with the potency testing of diphtheria and tetanus toxoids, two vaccines which are used extensively throughout the world. The relevance of the potency test prescribed by the European Pharmacopoeia monographs is questioned. The validity of the potency test as a model for the human response, the ability of the test to be standardised, and the relevance of the test in relation to the quality of the product are discussed. It is concluded that the potency test has only limited predictive value for the antitoxin responses to be expected in recipients of these toxoids. An alternative approach for estimating the potency of toxoid batches is discussed, in which a distinction is made between estimation of the immunogenic potency of the first few batches obtained from a seed lot and monitoring the consistency of the quality of subsequent batches. The use of animals is limited to the first few batches. Monitoring the consistency of the quality of subsequent batches is based on in vitro test methods. Factors which hamper the introduction and acceptance of the alternative approach are considered. Finally, proposals are made for replacement, reduction and/or refinement (the Three Rs) in the use of animals in the routine potency testing of toxoids.

scholarly journals Toward an Automatic Quality Assessment of Voice-Based Telemedicine Consultations: A Deep Learning Approach

Sensors ◽  
2021 ◽  
Vol 21 (9) ◽  
pp. 3279
Author(s):  
Maria Habib ◽  
Mohammad Faris ◽  
Raneem Qaddoura ◽  
Manal Alomari ◽  
Alaa Alomari ◽  
...  
Keyword(s):  
Neural Networks ◽  
Deep Learning ◽  
Quality Assessment ◽  
Transcript Level ◽  
Assessment Process ◽  
Classification Model ◽  
Systematic Evaluation ◽  
Transcript Levels ◽  
Perceptual Evaluation

Maintaining a high quality of conversation between doctors and patients is essential in telehealth services, where efficient and competent communication is important to promote patient health. Assessing the quality of medical conversations is often handled based on a human auditory-perceptual evaluation. Typically, trained experts are needed for such tasks, as they follow systematic evaluation criteria. However, the daily rapid increase of consultations makes the evaluation process inefficient and impractical. This paper investigates the automation of the quality assessment process of patient–doctor voice-based conversations in a telehealth service using a deep-learning-based classification model. For this, the data consist of audio recordings obtained from Altibbi. Altibbi is a digital health platform that provides telemedicine and telehealth services in the Middle East and North Africa (MENA). The objective is to assist Altibbi’s operations team in the evaluation of the provided consultations in an automated manner. The proposed model is developed using three sets of features: features extracted from the signal level, the transcript level, and the signal and transcript levels. At the signal level, various statistical and spectral information is calculated to characterize the spectral envelope of the speech recordings. At the transcript level, a pre-trained embedding model is utilized to encompass the semantic and contextual features of the textual information. Additionally, the hybrid of the signal and transcript levels is explored and analyzed. The designed classification model relies on stacked layers of deep neural networks and convolutional neural networks. Evaluation results show that the model achieved a higher level of precision when compared with the manual evaluation approach followed by Altibbi’s operations team.

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