(Q)SAR Assessment Framework: Guidance for Assessing (Q)SAR Models and Predict...hannahthabet
The webinar provided an overview of the new OECD (Q)SAR Assessment Framework for evaluating the scientific validity of (Q)SAR models, predictions, and results from multiple predictions. The QAF provides assessment elements for existing principles for evaluating models, as well as new principles for evaluating predictions and results. In addition to the principles, assessment elements, and guidance for evaluating each element, the QAF includes a checklist for reporting assessments.
This new Framework provides regulators with a consistent and transparent approach for reviewing the use of (Q)SAR predictions in a regulatory context and increases the confidence to accept alternative methods for evaluating chemical hazards. The OECD worked closely together with the Istituto Superiore di Sanità (Italy) and the European Chemicals Agency (ECHA), supported by a variety of international experts to develop a checklist of criteria and guidance for evaluating each criterion. The aim of the QAF is to help establish confidence in the use of (Q)SARs in evaluating chemical safety, and was designed to be applicable irrespective of the modelling technique used to build the model, the predicted endpoint, and the intended regulatory purpose.
The webinar provided an overview of the project and presented the main aspects of the framework for assessing models and results based on individual or multiple predictions.
Basic skills training guide hplc method development and validation- an over...bmarkandeya
This document provides an overview of HPLC method development and validation. It focuses on optimizing HPLC conditions and discusses various critical steps in analytical method development and validation. These include developing a stability-indicating HPLC method to analyze degradation products during stability studies and validating the method to demonstrate its suitability for intended use. Key aspects of method development and validation covered are sample preparation, HPLC analysis, standardization, and quantitative measures of column efficiency.
Calibration and Validation of Micro-Simulation ModelsWSP
Calibration and Validation of Micro-Simulation Models is a presentation delivered by François Bélisle, Eng., B.Sc., M.Sc., WSP | Parsons Brinckerhoff, Laurent Gauthier, Polytechnique Montréal and Nicolas Saunier, Polytechnique Montréal at the 2015 Transportation Association of Canada (TAC) Conference & Exhibition, from September 27 to 30.
Are we using the correct quality goals?Ola Elgaddar
Setting quality goals / specifications is a debatable issue since 1999. I am trying here to show the options and the continuos trials from several professional bodies to reach a consensus in this matter.
This was an oral presentation in the first international conference of the Chemical Pathology Department, Medical Research Institute, Alexandria University - February 2016
Root cause Analysis (RCA) & Corrective and Preventive action (CAPA) in MRCT d...Bhaswat Chakraborty
This presentation describes Identification & differentiation of Protocol deviation & violation; Different methods of RCA & best suitable method for Multiregional Clinical Trial; CAPA management and CAPA application to other trial sites/CRO/SMO/ Country that is involved in same trial (Strategic Management and application of CAPA in MRCT)
Conduct title screening for systemic review- using Endnote Covidence – Pubric...Pubrica
Title screening process
Title screening overview
How do I screen?
Endnote overview:
Covidence overview:
Continue Reading: https://bit.ly/3AeFIYY
For our services: https://pubrica.com/services/research-services/systematic-review/
Why Pubrica:
When you order our services, We promise you the following – Plagiarism free | always on Time | 24*7 customer support | Written to international Standard | Unlimited Revisions support | Medical writing Expert | Publication Support | Biostatistical experts | High-quality Subject Matter Experts.
Contact us:
Web: https://pubrica.com/
Blog: https://pubrica.com/academy/
Email: sales@pubrica.com
WhatsApp : +91 9884350006
United Kingdom: +44-1618186353
Analytical Target Profile (ATP) - Structure and Application Throughout the An...pi
ICH Q2: Validation of Analytical Procedures describes the current concepts of validation, verification and transfer of procedures. This approach addresses portions of the analytical lifecycle but also has a number of downsides. As an alternative to this approach, predefined criteria can be established in the form of an Analytical Target Profile (ATP).
(Q)SAR Assessment Framework: Guidance for Assessing (Q)SAR Models and Predict...hannahthabet
The webinar provided an overview of the new OECD (Q)SAR Assessment Framework for evaluating the scientific validity of (Q)SAR models, predictions, and results from multiple predictions. The QAF provides assessment elements for existing principles for evaluating models, as well as new principles for evaluating predictions and results. In addition to the principles, assessment elements, and guidance for evaluating each element, the QAF includes a checklist for reporting assessments.
This new Framework provides regulators with a consistent and transparent approach for reviewing the use of (Q)SAR predictions in a regulatory context and increases the confidence to accept alternative methods for evaluating chemical hazards. The OECD worked closely together with the Istituto Superiore di Sanità (Italy) and the European Chemicals Agency (ECHA), supported by a variety of international experts to develop a checklist of criteria and guidance for evaluating each criterion. The aim of the QAF is to help establish confidence in the use of (Q)SARs in evaluating chemical safety, and was designed to be applicable irrespective of the modelling technique used to build the model, the predicted endpoint, and the intended regulatory purpose.
The webinar provided an overview of the project and presented the main aspects of the framework for assessing models and results based on individual or multiple predictions.
Basic skills training guide hplc method development and validation- an over...bmarkandeya
This document provides an overview of HPLC method development and validation. It focuses on optimizing HPLC conditions and discusses various critical steps in analytical method development and validation. These include developing a stability-indicating HPLC method to analyze degradation products during stability studies and validating the method to demonstrate its suitability for intended use. Key aspects of method development and validation covered are sample preparation, HPLC analysis, standardization, and quantitative measures of column efficiency.
Calibration and Validation of Micro-Simulation ModelsWSP
Calibration and Validation of Micro-Simulation Models is a presentation delivered by François Bélisle, Eng., B.Sc., M.Sc., WSP | Parsons Brinckerhoff, Laurent Gauthier, Polytechnique Montréal and Nicolas Saunier, Polytechnique Montréal at the 2015 Transportation Association of Canada (TAC) Conference & Exhibition, from September 27 to 30.
Are we using the correct quality goals?Ola Elgaddar
Setting quality goals / specifications is a debatable issue since 1999. I am trying here to show the options and the continuos trials from several professional bodies to reach a consensus in this matter.
This was an oral presentation in the first international conference of the Chemical Pathology Department, Medical Research Institute, Alexandria University - February 2016
Root cause Analysis (RCA) & Corrective and Preventive action (CAPA) in MRCT d...Bhaswat Chakraborty
This presentation describes Identification & differentiation of Protocol deviation & violation; Different methods of RCA & best suitable method for Multiregional Clinical Trial; CAPA management and CAPA application to other trial sites/CRO/SMO/ Country that is involved in same trial (Strategic Management and application of CAPA in MRCT)
Conduct title screening for systemic review- using Endnote Covidence – Pubric...Pubrica
Title screening process
Title screening overview
How do I screen?
Endnote overview:
Covidence overview:
Continue Reading: https://bit.ly/3AeFIYY
For our services: https://pubrica.com/services/research-services/systematic-review/
Why Pubrica:
When you order our services, We promise you the following – Plagiarism free | always on Time | 24*7 customer support | Written to international Standard | Unlimited Revisions support | Medical writing Expert | Publication Support | Biostatistical experts | High-quality Subject Matter Experts.
Contact us:
Web: https://pubrica.com/
Blog: https://pubrica.com/academy/
Email: sales@pubrica.com
WhatsApp : +91 9884350006
United Kingdom: +44-1618186353
Analytical Target Profile (ATP) - Structure and Application Throughout the An...pi
ICH Q2: Validation of Analytical Procedures describes the current concepts of validation, verification and transfer of procedures. This approach addresses portions of the analytical lifecycle but also has a number of downsides. As an alternative to this approach, predefined criteria can be established in the form of an Analytical Target Profile (ATP).
The document discusses the application of statistical tools to enhance productivity and quality control in industries. It explains key concepts like process control, process capability indices, acceptance sampling plans, and their use in quality management. Statistical process control techniques like control charts are used to monitor processes and make data-driven decisions about product and process quality. Acceptance sampling balances protecting consumers from defects and encouraging quality production.
The document discusses life cycle assessment (LCA), which analyzes the environmental impacts of a product or system throughout its life cycle from raw material extraction through production, use, and disposal or recycling. It outlines the 4 stages of LCA: 1) goal and scope definition, 2) inventory analysis, 3) impact assessment, and 4) interpretation. Key points include that LCA considers all inputs/outputs and environmental effects at each stage, allows comparison of alternatives, but depends on available data and does not consider economic or social factors. Case studies on wind turbines and palm oil biodiesel production demonstrate applying LCA over the full life cycle.
This document provides an overview and summary of key concepts related to analytical method validation for liquid chromatography. It discusses topics such as specificity, linearity and range, precision, accuracy, detection limit, quantitation limit, robustness, and system suitability. Examples and definitions are provided for each concept. Chromatograms, plots, and tables are also included to help illustrate key points.
Effective handling of OOS investigations involves adhering to OOS investigation guidelines to ensure thorough analysis and resolution. Following robust protocols and regulatory standards in OOS investigation processes is crucial for maintaining product quality and compliance.
Read more here https://www.ipa-india.org/wp-content/uploads/2023/05/Presentation-on-Handling-OOS-Investigations-Regulatory-Expectations-Dipesh-Shah-Comsumer-Safety-Officer-USFDA.pdf
FDA OOS investigation India (Out of Specifications).pdfmidohamada2
Dipesh Shah, a consumer safety officer, discusses regulatory expectations for handling out-of-specification (OOS) investigations in India. The guidance outlines a two-phase process for OOS investigations to determine if a result was due to a laboratory error or a production issue. Phase I involves a laboratory investigation and Phase II involves a full production review if no error is found. The guidance stresses that investigations must be scientifically sound, supported by evidence, and result in effective corrective actions to prevent future OOS results. Common problems cited include failing to identify the root cause or evaluate the impact on other batches.
The document provides an overview of analytical quality by design (AQbD) and a case study on optimizing an HPLC method for quantification of an unknown impurity in a drug product. Key aspects included:
- Defining the analytical target profile (ATP) and critical quality attributes (CQA) for the method
- Conducting a qualitative risk assessment to identify critical method parameters using a prioritization matrix
- Performing a quantitative risk assessment using FMECA to calculate risk priority numbers and identify high, medium, and low risk factors
- Selecting experimental factors (column temperature, particle size, etc.), response variables (resolution, retention time), and constant factors for the design of experiments study.
Analytical method- Content, Development, validation, Transfer & Life Cycle Ma...Md. Mizanur Rahman Miajee
This document discusses analytical method validation and provides guidelines on developing and validating analytical methods according to regulatory standards. It outlines the key components that should be included in an analytical method as well as considerations for method development such as selecting stationary and mobile phases, operating parameters, and evaluating method performance characteristics during development. The document also discusses best practices for transferring validated analytical methods between laboratories.
This document discusses quality assurance in mycobacteriology laboratories. It describes the three main components of a quality assurance system as quality control, external quality assessment, and quality improvement. Quality control procedures should address pre-analytical, analytical, and post-analytical phases of testing. Monitoring performance indicators such as contamination rates, turnaround times, and proficiency testing scores helps to evaluate laboratory performance and identify areas for improvement.
This document outlines the structure and key elements that should be included in a systematic review report. It recommends including an abstract, introduction, methods, results, discussion and conclusion sections. The methods section should describe the literature search strategy, eligibility criteria, data extraction and quality assessment processes. Results should be presented according to the review questions. The discussion should synthesize the findings, discuss limitations and draw conclusions. Guidelines like PRISMA can help improve reporting quality.
A Guide To Performing Systematic Literature Reviews In BioinformaticsLori Moore
This document provides guidelines for performing a systematic literature review (SLR) in bioinformatics, called BiSLR. The BiSLR method is divided into four main steps: 1) defining a protocol that establishes the objectives and questions guiding the SLR, 2) collecting relevant references from literature databases, 3) evaluating the collected data by screening titles, abstracts, and full texts to identify papers that meet the inclusion criteria, and 4) interpreting the findings by summarizing and analyzing the included papers and extracting relevant data. The guidelines aim to help bioinformaticians conduct reproducible and unbiased SLRs to comprehensively summarize research on a topic and collect accurate data for analysis. A case study demonstrates applying the BiSLR steps
Theory of hplc_quantitative_and_qualitative_hplcVanya Dimcheva
This document discusses quantitative HPLC analysis. It defines quantitative analysis as determining the concentration of a compound in a sample by comparing the response of an unknown sample to known standard samples of various concentrations. It outlines the key steps in quantitative analysis including establishing a method, analyzing standard samples to generate a calibration curve, analyzing unknown samples, and comparing the unknown response to the standard curve to determine concentration. It also discusses some chromatographic requirements for robust quantitative analysis such as separated peaks, symmetrical peak shapes, and stable baselines.
The document discusses applying a lifecycle management model to analytical procedures. It proposes a three stage model: 1) Procedure Design involving development and understanding potential variables, 2) Procedure Performance Qualification demonstrating fitness for purpose, and 3) Continued Procedure Performance Verification involving routine monitoring. Key aspects include defining an Analytical Target Profile specifying performance criteria, conducting risk assessments of potential variables, and establishing control strategies. The lifecycle approach aims to better integrate validation, transfer, and verification, with the Analytical Target Profile serving as an overall reference point.
A Review Analytical Quality Control and Methodology in Internal Quality Contr...ijtsrd
This document discusses analytical quality control (AQC) and internal quality control (IQC) processes for ensuring accurate laboratory analysis. It describes how AQC involves all processes designed to ensure consistent, comparable, and accurate results within certain limits. IQC is important for maintaining accuracy of results over time by analyzing control samples alongside test samples. The document recommends a three-phase IQC design with the goals of high error detection, low false rejection rates, and defining the duration of analytical runs using integrated normal patient data. Quality control samples should have similar matrices to samples, be easy to use, stable, available in sufficient quantities, and have target values close to samples.
This document outlines the protocol for developing a systematic review. It discusses setting the research question and scope of the review, including important outcomes. It also addresses setting eligibility criteria for including studies, such as defining participants, interventions, comparators and outcomes. Finally, it discusses planning the review methods like searching for studies, assessing risk of bias, and synthesizing results. The goal is to develop a protocol that clearly defines all aspects of the review methodology to guide the review process.
Gaining acceptance in next generation PBK modelling approaches for regulatory...OECD Environment
On 10 May 2021, the OECD presented the recently published Guidance Document on the Characterisation, Validation and Reporting of Physiologically Based Kinetic (PBK) Models for Regulatory Purposes. This guidance aims to increase the confidence in the use of PBK models parameterised with data derived from in vitro and in silico methods, and help address “unfamiliar” uncertainties associated with these methods.
The webinar introduced the assessment framework for PBK models that was developed to evaluate the attributes and uncertainties of these models, including a dedicated discussion on sensitivity analysis. It also focused on the scientific workflow for characterising and validating PBK models together with a template for documenting PBK models in a systematic manner and a checklist to support model evaluation.
Check out the webinar video recording at: https://youtu.be/PT7w6PB97Ag and access the Guidance Document on the Characterisation, Validation and Reporting of Physiologically Based Kinetic (PBK) Models for Regulatory Purposes at: https://www.oecd.org/chemicalsafety/risk-assessment/guidance-document-on-the-characterisation-validation-and-reporting-of-physiologically-based-kinetic-models-for-regulatory-purposes.pdf.
This document provides an overview of analytical method validation for biopharmaceuticals. It discusses the different types of analytical methods used in the biopharmaceutical industry, including screening methods, release and stability methods, and characterization methods. It emphasizes that method validation is important but guidelines have focused on validation for commercial products, leaving a gap for earlier stages of development. The document then discusses best practices for qualifying characterization methods and release/stability methods to demonstrate suitability for intended use during development.
This document outlines a course on multivariate data analysis. It introduces key topics that will be covered, including matrix algebra, the multivariate normal distribution, principal component analysis, factor analysis, cluster analysis, discriminant analysis, and canonical correlations. The course workload consists of 40% theory and 60% practice, including a group project and weekly presentations. R will be the main software used. Examples of multivariate data and applications in various fields like business, health, and education are also provided.
2016 LabHIT LRI EHR Test Methods for CLIA ComplianceMegan Sawchuk
1) The document summarizes work to develop test methods for the Laboratory Results Interface certification criteria to ensure electronic health records comply with all Clinical Laboratory Improvement Amendments (CLIA) regulations for laboratory test reports.
2) Existing use cases were evaluated and enhanced to include all required CLIA elements, and new use cases were developed to test corrected laboratory reports.
3) The resulting test methods within the National Institute of Standards and Technology's HL7 validation tool allow EHR vendors to determine if their systems are compliant with CLIA regulations for electronic laboratory test reports.
The document discusses the life cycle of analytical methods from development through continued use. It proposes a new general chapter called "The Analytical Procedure Lifecycle" to provide a holistic framework. Key points include establishing analytical target profiles, assuring methods remain in a state of control, evaluating measurement uncertainty, and using quality-by-design to increase robustness and reduce lifecycle costs. Regular monitoring and trend analysis can identify needs for optimization or revalidation to ensure methods remain fit for their intended purpose over time.
A practical guide to do primary research on meta analysis methodology - PubricaPubrica
• Conventional meta-analysis research techniques are extended to accommodate methods and practices found in basic research.
• Apart from clinical research, where consolidation efforts are facilitated by systematic review and meta-analysis research, basic science occasionally use such rigorous quantitative methods.
Reference: http://bit.ly/2N2iVg8
Continue Reading: https://pubrica.com/services/research-services/meta-analysis/
Why Pubrica?
When you order our services, Plagiarism free|onTime|outstanding customer support|Unlimited Revisions support|High-quality Subject Matter Experts.
Contact us :
Web: https://pubrica.com/
Blog: https://pubrica.com/academy/
Email: sales@pubrica.com
WhatsApp : +91 9884350006
United Kingdom: +44- 74248 10299
The document discusses the application of statistical tools to enhance productivity and quality control in industries. It explains key concepts like process control, process capability indices, acceptance sampling plans, and their use in quality management. Statistical process control techniques like control charts are used to monitor processes and make data-driven decisions about product and process quality. Acceptance sampling balances protecting consumers from defects and encouraging quality production.
The document discusses life cycle assessment (LCA), which analyzes the environmental impacts of a product or system throughout its life cycle from raw material extraction through production, use, and disposal or recycling. It outlines the 4 stages of LCA: 1) goal and scope definition, 2) inventory analysis, 3) impact assessment, and 4) interpretation. Key points include that LCA considers all inputs/outputs and environmental effects at each stage, allows comparison of alternatives, but depends on available data and does not consider economic or social factors. Case studies on wind turbines and palm oil biodiesel production demonstrate applying LCA over the full life cycle.
This document provides an overview and summary of key concepts related to analytical method validation for liquid chromatography. It discusses topics such as specificity, linearity and range, precision, accuracy, detection limit, quantitation limit, robustness, and system suitability. Examples and definitions are provided for each concept. Chromatograms, plots, and tables are also included to help illustrate key points.
Effective handling of OOS investigations involves adhering to OOS investigation guidelines to ensure thorough analysis and resolution. Following robust protocols and regulatory standards in OOS investigation processes is crucial for maintaining product quality and compliance.
Read more here https://www.ipa-india.org/wp-content/uploads/2023/05/Presentation-on-Handling-OOS-Investigations-Regulatory-Expectations-Dipesh-Shah-Comsumer-Safety-Officer-USFDA.pdf
FDA OOS investigation India (Out of Specifications).pdfmidohamada2
Dipesh Shah, a consumer safety officer, discusses regulatory expectations for handling out-of-specification (OOS) investigations in India. The guidance outlines a two-phase process for OOS investigations to determine if a result was due to a laboratory error or a production issue. Phase I involves a laboratory investigation and Phase II involves a full production review if no error is found. The guidance stresses that investigations must be scientifically sound, supported by evidence, and result in effective corrective actions to prevent future OOS results. Common problems cited include failing to identify the root cause or evaluate the impact on other batches.
The document provides an overview of analytical quality by design (AQbD) and a case study on optimizing an HPLC method for quantification of an unknown impurity in a drug product. Key aspects included:
- Defining the analytical target profile (ATP) and critical quality attributes (CQA) for the method
- Conducting a qualitative risk assessment to identify critical method parameters using a prioritization matrix
- Performing a quantitative risk assessment using FMECA to calculate risk priority numbers and identify high, medium, and low risk factors
- Selecting experimental factors (column temperature, particle size, etc.), response variables (resolution, retention time), and constant factors for the design of experiments study.
Analytical method- Content, Development, validation, Transfer & Life Cycle Ma...Md. Mizanur Rahman Miajee
This document discusses analytical method validation and provides guidelines on developing and validating analytical methods according to regulatory standards. It outlines the key components that should be included in an analytical method as well as considerations for method development such as selecting stationary and mobile phases, operating parameters, and evaluating method performance characteristics during development. The document also discusses best practices for transferring validated analytical methods between laboratories.
This document discusses quality assurance in mycobacteriology laboratories. It describes the three main components of a quality assurance system as quality control, external quality assessment, and quality improvement. Quality control procedures should address pre-analytical, analytical, and post-analytical phases of testing. Monitoring performance indicators such as contamination rates, turnaround times, and proficiency testing scores helps to evaluate laboratory performance and identify areas for improvement.
This document outlines the structure and key elements that should be included in a systematic review report. It recommends including an abstract, introduction, methods, results, discussion and conclusion sections. The methods section should describe the literature search strategy, eligibility criteria, data extraction and quality assessment processes. Results should be presented according to the review questions. The discussion should synthesize the findings, discuss limitations and draw conclusions. Guidelines like PRISMA can help improve reporting quality.
A Guide To Performing Systematic Literature Reviews In BioinformaticsLori Moore
This document provides guidelines for performing a systematic literature review (SLR) in bioinformatics, called BiSLR. The BiSLR method is divided into four main steps: 1) defining a protocol that establishes the objectives and questions guiding the SLR, 2) collecting relevant references from literature databases, 3) evaluating the collected data by screening titles, abstracts, and full texts to identify papers that meet the inclusion criteria, and 4) interpreting the findings by summarizing and analyzing the included papers and extracting relevant data. The guidelines aim to help bioinformaticians conduct reproducible and unbiased SLRs to comprehensively summarize research on a topic and collect accurate data for analysis. A case study demonstrates applying the BiSLR steps
Theory of hplc_quantitative_and_qualitative_hplcVanya Dimcheva
This document discusses quantitative HPLC analysis. It defines quantitative analysis as determining the concentration of a compound in a sample by comparing the response of an unknown sample to known standard samples of various concentrations. It outlines the key steps in quantitative analysis including establishing a method, analyzing standard samples to generate a calibration curve, analyzing unknown samples, and comparing the unknown response to the standard curve to determine concentration. It also discusses some chromatographic requirements for robust quantitative analysis such as separated peaks, symmetrical peak shapes, and stable baselines.
The document discusses applying a lifecycle management model to analytical procedures. It proposes a three stage model: 1) Procedure Design involving development and understanding potential variables, 2) Procedure Performance Qualification demonstrating fitness for purpose, and 3) Continued Procedure Performance Verification involving routine monitoring. Key aspects include defining an Analytical Target Profile specifying performance criteria, conducting risk assessments of potential variables, and establishing control strategies. The lifecycle approach aims to better integrate validation, transfer, and verification, with the Analytical Target Profile serving as an overall reference point.
A Review Analytical Quality Control and Methodology in Internal Quality Contr...ijtsrd
This document discusses analytical quality control (AQC) and internal quality control (IQC) processes for ensuring accurate laboratory analysis. It describes how AQC involves all processes designed to ensure consistent, comparable, and accurate results within certain limits. IQC is important for maintaining accuracy of results over time by analyzing control samples alongside test samples. The document recommends a three-phase IQC design with the goals of high error detection, low false rejection rates, and defining the duration of analytical runs using integrated normal patient data. Quality control samples should have similar matrices to samples, be easy to use, stable, available in sufficient quantities, and have target values close to samples.
This document outlines the protocol for developing a systematic review. It discusses setting the research question and scope of the review, including important outcomes. It also addresses setting eligibility criteria for including studies, such as defining participants, interventions, comparators and outcomes. Finally, it discusses planning the review methods like searching for studies, assessing risk of bias, and synthesizing results. The goal is to develop a protocol that clearly defines all aspects of the review methodology to guide the review process.
Gaining acceptance in next generation PBK modelling approaches for regulatory...OECD Environment
On 10 May 2021, the OECD presented the recently published Guidance Document on the Characterisation, Validation and Reporting of Physiologically Based Kinetic (PBK) Models for Regulatory Purposes. This guidance aims to increase the confidence in the use of PBK models parameterised with data derived from in vitro and in silico methods, and help address “unfamiliar” uncertainties associated with these methods.
The webinar introduced the assessment framework for PBK models that was developed to evaluate the attributes and uncertainties of these models, including a dedicated discussion on sensitivity analysis. It also focused on the scientific workflow for characterising and validating PBK models together with a template for documenting PBK models in a systematic manner and a checklist to support model evaluation.
Check out the webinar video recording at: https://youtu.be/PT7w6PB97Ag and access the Guidance Document on the Characterisation, Validation and Reporting of Physiologically Based Kinetic (PBK) Models for Regulatory Purposes at: https://www.oecd.org/chemicalsafety/risk-assessment/guidance-document-on-the-characterisation-validation-and-reporting-of-physiologically-based-kinetic-models-for-regulatory-purposes.pdf.
This document provides an overview of analytical method validation for biopharmaceuticals. It discusses the different types of analytical methods used in the biopharmaceutical industry, including screening methods, release and stability methods, and characterization methods. It emphasizes that method validation is important but guidelines have focused on validation for commercial products, leaving a gap for earlier stages of development. The document then discusses best practices for qualifying characterization methods and release/stability methods to demonstrate suitability for intended use during development.
This document outlines a course on multivariate data analysis. It introduces key topics that will be covered, including matrix algebra, the multivariate normal distribution, principal component analysis, factor analysis, cluster analysis, discriminant analysis, and canonical correlations. The course workload consists of 40% theory and 60% practice, including a group project and weekly presentations. R will be the main software used. Examples of multivariate data and applications in various fields like business, health, and education are also provided.
2016 LabHIT LRI EHR Test Methods for CLIA ComplianceMegan Sawchuk
1) The document summarizes work to develop test methods for the Laboratory Results Interface certification criteria to ensure electronic health records comply with all Clinical Laboratory Improvement Amendments (CLIA) regulations for laboratory test reports.
2) Existing use cases were evaluated and enhanced to include all required CLIA elements, and new use cases were developed to test corrected laboratory reports.
3) The resulting test methods within the National Institute of Standards and Technology's HL7 validation tool allow EHR vendors to determine if their systems are compliant with CLIA regulations for electronic laboratory test reports.
The document discusses the life cycle of analytical methods from development through continued use. It proposes a new general chapter called "The Analytical Procedure Lifecycle" to provide a holistic framework. Key points include establishing analytical target profiles, assuring methods remain in a state of control, evaluating measurement uncertainty, and using quality-by-design to increase robustness and reduce lifecycle costs. Regular monitoring and trend analysis can identify needs for optimization or revalidation to ensure methods remain fit for their intended purpose over time.
A practical guide to do primary research on meta analysis methodology - PubricaPubrica
• Conventional meta-analysis research techniques are extended to accommodate methods and practices found in basic research.
• Apart from clinical research, where consolidation efforts are facilitated by systematic review and meta-analysis research, basic science occasionally use such rigorous quantitative methods.
Reference: http://bit.ly/2N2iVg8
Continue Reading: https://pubrica.com/services/research-services/meta-analysis/
Why Pubrica?
When you order our services, Plagiarism free|onTime|outstanding customer support|Unlimited Revisions support|High-quality Subject Matter Experts.
Contact us :
Web: https://pubrica.com/
Blog: https://pubrica.com/academy/
Email: sales@pubrica.com
WhatsApp : +91 9884350006
United Kingdom: +44- 74248 10299
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Emerging Earth Observation methods for monitoring sustainable food productionCIFOR-ICRAF
Presented by Daniela Requena Suarez, Helmholtz GeoResearch Center Potsdam (GFZ) at "Side event 60th sessions of the UNFCCC Subsidiary Bodies - Sustainable Bites: Innovating Low Emission Food Systems One Country at a Time" on 13 June 2024
Monitor indicators of genetic diversity from space using Earth Observation dataSpatial Genetics
Genetic diversity within and among populations is essential for species persistence. While targets and indicators for genetic diversity are captured in the Kunming-Montreal Global Biodiversity Framework, assessing genetic diversity across many species at national and regional scales remains challenging. Parties to the Convention on Biological Diversity (CBD) need accessible tools for reliable and efficient monitoring at relevant scales. Here, we describe how Earth Observation satellites (EO) make essential contributions to enable, accelerate, and improve genetic diversity monitoring and preservation. Specifically, we introduce a workflow integrating EO into existing genetic diversity monitoring strategies and present a set of examples where EO data is or can be integrated to improve assessment, monitoring, and conservation. We describe how available EO data can be integrated in innovative ways to support calculation of the genetic diversity indicators of the GBF monitoring framework and to inform management and monitoring decisions, especially in areas with limited research infrastructure or access. We also describe novel, integrative approaches to improve the indicators that can be implemented with the coming generation of EO data, and new capabilities that will provide unprecedented detail to characterize the changes to Earth’s surface and their implications for biodiversity, on a global scale.
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The modification of an existing product or the formulation of a new product to fill a newly identified market niche or customer need are both examples of product development. This study generally developed and conducted the formulation of aramang baked products enriched with malunggay conducted by the researchers. Specifically, it answered the acceptability level in terms of taste, texture, flavor, odor, and color also the overall acceptability of enriched aramang baked products. The study used the frequency distribution for evaluators to determine the acceptability of enriched aramang baked products enriched with malunggay. As per sensory evaluation conducted by the researchers, it was proven that aramang baked products enriched with malunggay was acceptable in terms of Odor, Taste, Flavor, Color, and Texture. Based on the results of sensory evaluation of enriched aramang baked products proven that three (3) treatments were all highly acceptable in terms of variable Odor, Taste, Flavor, Color and Textures conducted by the researchers.
2. Smart Powertrain Lab.
Outline
6.1 Introduction
6.2 LCA Interpretation according to ISO
6.3 Uncertainty and Sensitivity Analysis
6.4 Contribution Analysis
6.5 Presenting LCIA Results
6.6 Preparing the Final Report
6.7 The Review Process
6.8 Product Category Rules and Environmental Product
Additional Information
3. Smart Powertrain Lab.
This chapter explores the key features of LCA interpretation,
including the following:
• The use of a systematic procedure to identify, qualify, check,
evaluate and present the conclusions based on the results of an
LCA or LCI, in order to meet the requirements of the application
as described in the goal and scope of the study;
• The use of an iterative procedure both within the interpretative
phase and with the other phases of an LCA;
• Maintaining transparency throughout the interpretation phase by
clearly stating in the final report any and all preferences,
assumptions, or value choices that were used in the
assessment or in reporting.
CONTENT
4. Smart Powertrain Lab.
• The results from an LCA can be difficult to comprehend because of
the vast amount of data, diversity of physical units, use of value
judgments, and uncertainty in the parameters. These factors limit its
capacity to directly, and transparently, interpret information for
decision makers (Canis et al 2010, Boufateh et al 2011).
• As a result, many comparative LCA studies stop the assessment
after calculation of potential impact indicators (characterized data),
leaving the decision makers to confront multi-criteria, multi-
stakeholder problems unaided (Rogers et al 2008, Rowley and
Peters 2009).
• This can lead to confusion and bias since human cognitive ability to
process large amounts of data is limited and subject to systematic
flaws (Hertwich and Hammit 2001).
6.1 Introduction
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• LCA study is a highly iterative process, so that the LCA practitioner
may need to go back to the goal and scope after the preliminary
inventory work, to move back from impact assessment to inventory
analysis, to have a look at the interpretation in an early stage, etc.
6.1 Introduction
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LCA cannot determine if a product is “sustainable” or “environmentally
friendly”
The results can only indicate if product X is “more sustainable” or “more
environmentally friendly” than product Y, or that the use phase is the “least
sustainable” or “least environmentally friendly” part of the life cycle for product Z
6.1 Introduction
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6.2 LCA Interpretation according to ISO
• Phase of LCA in which the findings of either the LCI (LC Inventory
analysis) or LCIA (LC the impact assessment), or both, are evaluated
in relation to the defined goal and scope in order to reach
conclusions and recommendations.
• The standard defines two objectives of life cycle interpretation:
• Analyze results, reach conclusions, explain limitations, and
provide recommendations based on the findings of the
preceding phases of the LCA, and to report the results of the life
cycle interpretation in a transparent manner.
• Provide a readily understandable, complete, and consistent
presentation of the results of an LCA study, in accordance with
the goal and scope of the study.
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An evaluation that considers:
Completeness check- to ensure that all relevant information and data are available
and complete
Sensitivity analysis - to assess the reliability of the final results and conclusions
Consistency check - to determine whether the assumptions, methods and data are
consistent with the goal and scope;
If The uncertainties are too high, then those steps must be repeated until the results can
support the original goals of the study.
6.2 LCA Interpretation according to ISO
The same applies to most
guidebooks on LCA. They
mention carrying out an
uncertainty analysis, but
give no clear guidance on how
this should be done.
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ISO 14040 describes that Potential sources of uncertainty include:
• The data source itself (random or systematic error in measurement
and
• sampling or natural variability),
• Any assumptions and/or calculation use to manipulate data, and
Aggregating very different data sources or values.
6.3 Uncertainty and Sensitivity Analysis
Sensitivity analysis can be used to indicate which parameters are most
important to the analysis. Both sensitivity analysis and uncertainty
analysis
are useful in determining where data quality resources should be
directed
or redirected. sources or values.
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1. Uncertainty Analysis
2. Uncertainty in Impact models
3. Sensitivity Analysis
4. Monte Carlo Simulation
6.3 Uncertainty and Sensitivity Analysis
Sensitivity analysis can be used to indicate which parameters are most
important to the analysis. Both sensitivity analysis and uncertainty
analysis
are useful in determining where data quality resources should be
directed
or redirected. sources or values.
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• Due to the uncertainty with inventory and impact data, it may not be
possible to state that one alternative is better than the others
because of the uncertainty in the final results
6.3.1 Uncertainty Analysis
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• In cases where the choice of methodology has a strong influence
on the study results and conclusions, the practitioner should justify
the reasons for the methodology chosen, and a sensitivity analysis
should be conducted to see if an alternative methodological choice
produces similar or different results and conclusions.
• For example, because of the many uncertainties surrounding
biomass decomposition in landfills, it is advisable to conduct
sensitivity analyses on the carbon storage and releases associated
with landfilled biomass products.
• Typical environmental and human health impact models, such as
those used in risk assessment, are based on exposure and effect
(that is,where the substance goes once it is emitted to the
environment, who is exposed to the substance and how much, and
how toxic the substance is). Effects on human health are based on
data developed in toxicological studies where safety factor are set
to determine acceptable daily intake.
6.3.2 Uncertainty in Impact Models
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Sensitivity analysis is done by systematically changing an input parameter and
observing the impact on the results. It may be useful in the following situations:
• The analyst does not have a high degree of confidence in an important data
source,
• The production system being assessed is highly variable, or Data for a particular
element are missing or deficient (EPA 1995).
The
6.3.3 Sensitivity Analysis
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Monte Carlo simulation is a widely used method to perform uncertainty and
sensitivity analysis. It uses statistical sampling techniques to approximate the
probability of certain outcomes by running multiple trial runs, called simulations,
using random variables. Many commercial LCA programs now offer Monte Carlo
analysis.
6.3.4 Monte Carlo Simulation
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6.6 Preparing the Final Report
The report presents the results, data, methods, assumptions, and limitations in
sufficient detail to allow the reader to comprehend the complexities and trade-offs
inherent in the LCA study.
Chapter 6 Life Cycle Assessment: Interpretation and
Reporting
The reference document should consist of the following elements (ISO 1997):
1. Administrative Information
a. Name and address of LCA practitioner (who conducted the LCA study)
b. Date of report
c. Other contact information or release information
2. Definition of Goal and Scope
3. Life Cycle Inventory Analysis (data collection and calculation procedures)
4. Life Cycle Impact Assessment (methodology and results of the impact assessment
that was performed)
5. Life Cycle Interpretation
a. Results
b. Assumptions and limitations
c. Data quality assessment (including findings of uncertainty and sensitivity)
6. Critical Review (internal and external)
a. Name and affiliation of reviewers
b. Critical review reports
c. Responses to recommendations
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6.7 The Review Process
ISO 14044 (2006) specifically identifies five requirements in the critical review process
Clause 6.1 General
The critical review process shall ensure that:
– the methods used to carry out the LCA are consistent with this international standard;
– the methods used to carry out the LCA are scientifically and technically valid;
– the data used are appropriate and reasonable in relation to the goal of the study;
– the interpretations reflect the limitations identified and the goal of the study;
– the study report is transparent and consistent.
Figure 6.7 Timing the Peer Review
Chapter 6 Life Cycle Assessment: Interpretation and
Reporting
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6.8 Product Category Rules and Environmental Product Declarations
A classification system for voluntary labels has been presented in the ISO 14020
series categorizing environmental product and service claims as Type I (third party
certified, specifics in ISO 14024), Type II (self-declared, specifics in ISO 14021), and
Type III (third party based on LCA, specifics in ISO 14025).
Of these ecolabeling types, Type III, also known as Environmental Product
Declarations, are the most closely tied to the LCA methodology.
o Type I, Type II, and Type III claims and their respective relationship with life cycle
assessment;
o Product Category Rules & Environmental Product Declarations;
o PCRs in Carbon Footprinting and Product Index development; and
o “Other relevant environmental information” within PCRs informed by other
assessment methods including: Water Footprinting, Toxicity Assessment and
Ecosystem Services Assessment.
Chapter 6 Life Cycle Assessment: Interpretation and
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6.8 Product Category Rules and Environmental Product Declarations
1. Type III Environmental
Product Declarations
2. An EPD is a Document
3. An EPD is Primarily
Based on LCA
4. An EPD is Developed by
Following a “Product
Category
Rule”
5. An EPD can contain other
Relevant Information beyond
the LCA
6. Further Information on
EPDs and PCRs
ISO 14025 (ISO 2006c) describes a Type III Environmental Product Declaration (EPD)
as a document which indicates the environmental performance of a specific product,
providing quantified environmental data developed using the LCA methodology set
forth in ISO 14040 and 14044 and a predetermined set of rules for the assessment
called “Product Category Rules” and, where relevant, additional environmental
information (e.g., toxicity in the use phase)
EPDs are described as nutrition labels including environmental information, however
it should be noted that solely a multi-attribute label expressing the life cycle impacts
assessment results for a product would not meet all of the required documentation
outlined in the ISO standard for an EPD
ISO 14025 specifically lists the ISO 14040 series as the basis for data and inventory
analysis supporting the development of an EPD and its supporting PCR
PCRs provide guidance on those areas of the LCA standards that are more nebulous
and tend to change depending on the goal and scope of the study. This guidance
includes: the determination of the functional unit, allocation rules, recommended
data sources, impact assessment methods, and additional relevant environmental
information that should be included to address environmental concerns
EPD’s should, by design, provide accurate quantification of environmental attributes
of products, communication of these attributes in a standardized and transparent
fashion, and permit comparison of one product to another with an EPD in the same
product category
Chapter 6 Life Cycle Assessment: Interpretation and
Reporting
EPDs can also include information that is not strictly specified in ISO 14025, but
referred to as “other relevant environmental information
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Additional Information
o The white 1-litre PET bottle is a
modern remake of the glass bottle
(used in Italy until the seventies); the
new container was designed with a
view to combining the value of
tradition with respect for the
environment and the need for a more
practical container.
o In relation to the handling of PET
bottles at the end of their life, it
should be pointed out that the
environmental impacts depend mainly
on the behavior of the end user and
the local availability of efficient
separate waste collection services;
o According to the statistics, on average,
PET waste in Italy is disposed of as
follows:
1. Recycling: 41%;
2. Waste to energy systems 30%.
3. Delivery to dump: 29%;
o There are two ways of recycling PET: it
can be transformed into secondary raw
material or it can be converted into
energy
Chapter 6 Life Cycle Assessment: Interpretation and
Reporting