The Experts below are selected from a list of 9309 Experts worldwide ranked by ideXlab platform
Katrina Campbell - One of the best experts on this subject based on the ideXlab platform.
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a review of the Global pesticide legislation and the scale of challenge in reaching the Global Harmonization of food safety standards
Integrated Environmental Assessment and Management, 2015Co-Authors: Caroline E Handford, Christopher T Elliott, Katrina CampbellAbstract:Pesticide use is important in agriculture to protect crops and improve productivity. However, pesticides have the potential to cause adverse human health or environmental effects, depending on exposure levels. This review examines existing pesticide legislation worldwide, focusing on the level of Harmonization and impacts of differing legislation on food safety and trade. Pesticide legislation varies greatly worldwide, because countries have different requirements, guidelines, and legal limits for plant protection. Developed nations have more stringent regulations than developing countries, which lack the resources and expertise to adequately implement and enforce legislation. Global differences in pesticide legislation act as a technical barrier to trade. International parties such as the European Union (EU), Codex Alimentarius Commission (Codex), and North American Free Trade Agreement (NAFTA) have attempted to harmonize pesticide legislation by providing maximum residue limits (MRLs), but Globally these limits remain variable. Globally harmonized pesticide standards would serve to increase productivity, profits, and trade and also enhance the ability to protect public health and the environment. Integr Environ Assess Manag 2015;9999:1–12. © 2015 SETAC
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a review of the Global pesticide legislation and the scale of challenge in reaching the Global Harmonization of food safety standards
Integrated Environmental Assessment and Management, 2015Co-Authors: Caroline E Handford, Christopher T Elliott, Katrina CampbellAbstract:Pesticide use is important in agriculture to protect crops and improve productivity. However, pesticides have the potential to cause adverse human health or environmental effects, depending on exposure levels. This review examines existing pesticide legislation worldwide, focusing on the level of Harmonization and impacts of differing legislation on food safety and trade. Pesticide legislation varies greatly worldwide, because countries have different requirements, guidelines, and legal limits for plant protection. Developed nations have more stringent regulations than developing countries, which lack the resources and expertise to adequately implement and enforce legislation. Global differences in pesticide legislation act as a technical barrier to trade. International parties such as the European Union (EU), Codex Alimentarius Commission (Codex), and North American Free Trade Agreement (NAFTA) have attempted to harmonize pesticide legislation by providing maximum residue limits (MRLs), but Globally these limits remain variable. Globally harmonized pesticide standards would serve to increase productivity, profits, and trade and also enhance the ability to protect public health and the environment.
Caroline E Handford - One of the best experts on this subject based on the ideXlab platform.
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a review of the Global pesticide legislation and the scale of challenge in reaching the Global Harmonization of food safety standards
Integrated Environmental Assessment and Management, 2015Co-Authors: Caroline E Handford, Christopher T Elliott, Katrina CampbellAbstract:Pesticide use is important in agriculture to protect crops and improve productivity. However, pesticides have the potential to cause adverse human health or environmental effects, depending on exposure levels. This review examines existing pesticide legislation worldwide, focusing on the level of Harmonization and impacts of differing legislation on food safety and trade. Pesticide legislation varies greatly worldwide, because countries have different requirements, guidelines, and legal limits for plant protection. Developed nations have more stringent regulations than developing countries, which lack the resources and expertise to adequately implement and enforce legislation. Global differences in pesticide legislation act as a technical barrier to trade. International parties such as the European Union (EU), Codex Alimentarius Commission (Codex), and North American Free Trade Agreement (NAFTA) have attempted to harmonize pesticide legislation by providing maximum residue limits (MRLs), but Globally these limits remain variable. Globally harmonized pesticide standards would serve to increase productivity, profits, and trade and also enhance the ability to protect public health and the environment. Integr Environ Assess Manag 2015;9999:1–12. © 2015 SETAC
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a review of the Global pesticide legislation and the scale of challenge in reaching the Global Harmonization of food safety standards
Integrated Environmental Assessment and Management, 2015Co-Authors: Caroline E Handford, Christopher T Elliott, Katrina CampbellAbstract:Pesticide use is important in agriculture to protect crops and improve productivity. However, pesticides have the potential to cause adverse human health or environmental effects, depending on exposure levels. This review examines existing pesticide legislation worldwide, focusing on the level of Harmonization and impacts of differing legislation on food safety and trade. Pesticide legislation varies greatly worldwide, because countries have different requirements, guidelines, and legal limits for plant protection. Developed nations have more stringent regulations than developing countries, which lack the resources and expertise to adequately implement and enforce legislation. Global differences in pesticide legislation act as a technical barrier to trade. International parties such as the European Union (EU), Codex Alimentarius Commission (Codex), and North American Free Trade Agreement (NAFTA) have attempted to harmonize pesticide legislation by providing maximum residue limits (MRLs), but Globally these limits remain variable. Globally harmonized pesticide standards would serve to increase productivity, profits, and trade and also enhance the ability to protect public health and the environment.
Bruno Lapauw - One of the best experts on this subject based on the ideXlab platform.
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Harmonization of serum thyroid stimulating hormone measurements paves the way for the adoption of a more uniform reference interval
Clinical Chemistry, 2017Co-Authors: Linda M Thienpont, Katleen Van Uytfanghe, Linde A C De Grande, Dries Reynders, Barnali Das, James D Faix, Finlay Mackenzie, Brigitte Decallonne, Akira Hishinuma, Bruno LapauwAbstract:BACKGROUND: The IFCC Committee for Standardization of Thyroid Function Tests developed a Global Harmonization approach for thyroid-stimulating hormone measurements. It is based on a multiassay method comparison study with clinical serum samples and target setting with a robust factor analysis method. Here we describe the Phase IV method comparison and reference interval (RI) studies conducted with the objective to recalibrate the participating assays and demonstrate the proof-of-concept. METHODS: Fourteen manufacturers measured the Harmonization and RI panel; 4 of them quantified the Harmonization and first follow-up panel in parallel. All recalibrated their assays to the statistically inferred targets. For validation, we used desirable specifications from the biological variation for the bias and total error (TE). The RI measurements were done with the assays9 current calibrators, but data were also reported after transformation to the new calibration status. We estimated the pre- and postrecalibration RIs with a nonparametric bootstrap procedure. RESULTS: After recalibration, 14 of 15 assays met the bias specification with 95% confidence; 8 assays complied with the TE specification. The CV of the assay means for the Harmonization panel was reduced from 9.5% to 4.2%. The RI study showed improved uniformity after recalibration: the ranges (i.e., maximum differences) exhibited by the assay-specific 2.5th, 50th, and 97.5th percentile estimates were reduced from 0.27, 0.89, and 2.13 mIU/L to 0.12, 0.29, and 0.77 mIU/L. CONCLUSIONS: We showed that Harmonization increased the agreement of results from the participating immunoassays, and may allow them to adopt a more uniform RI in the future.
Mei-ling Chen - One of the best experts on this subject based on the ideXlab platform.
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summary report of second eufeps aaps conference on Global Harmonization in bioequivalence
European Journal of Pharmaceutical Sciences, 2019Co-Authors: Mei-ling Chen, Henning Blume, Gerald Beuerle, Mehul Mehta, Henrike Potthast, Barbara Schug, Andreas Brandt, Murray P Ducharme, Laszlo Endrenyi, Keith GallicanoAbstract:The Global Bioequivalence Harmonization Initiative (GBHI) was launched by the Network on Bioavailability and Biopharmaceutics (BABP) under the auspices of European Federation for Pharmaceutical Sciences (EUFEPS) several years ago. Since 2015, EUFEPS in collaboration with the American Association of Pharmaceutical Scientists (AAPS) has organized three international conferences to support Global Harmonization of regulatory requirements for bioequivalence (BE) assessment. These conferences provided an open forum for pharmaceutical scientists from academia, industry and regulatory agencies to discuss various BE topics at issue. The current report summarizes the discussion of BE issues at the 2nd GBHI conference held in 2016, Rockville, USA. Three important BE topics were discussed at the meeting: (a) prodrugs and compounds with pre-systemic extraction, (b) scaling procedures and two-stage designs, and (c) exclusion of pharmacokinetic data in BE assessment. The presentations and discussions of these issues have enhanced the mutual understanding of scientific background for BE evaluation and further facilitated Harmonization of regulatory approaches for establishing BE of multisource drug products.
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the Global bioequivalence Harmonization initiative summary report for eufeps international conference
European Journal of Pharmaceutical Sciences, 2018Co-Authors: Mei-ling Chen, Henning Blume, Gerald Beuerle, Barbara Davit, Mehul Mehta, Henrike Potthast, Barbara Schug, Yu Chung Tsang, Ralphsteven Wedemeyer, Werner WeitschiesAbstract:Bioequivalence (BE) is considered one of the key questions in new and generic drug product development and registration worldwide. However, the regulations and jurisdiction vary from country to country and continent to continent. Harmonization of regulatory requirements and criteria for BE determination may avoid unnecessary repetition of BE studies and minimize drug exposure to humans. Harmonization around the globe may be achieved by a better understanding of scientific principles and expectations from different regulatory authorities. To facilitate Global Harmonization, the Network on Bioavailability and Biopharmaceutics (BABP) under the European Federation for Pharmaceutical Sciences (EUFEPS) launched a Global Bioequivalence Harmonization Initiative (GBHI) several years ago. This international conference was the first in a series of workshops organized by EUFEPS/BABP under GBHI. The workshop provided a forum for pharmaceutical scientists from academia, industry and regulatory agencies to have open discussions on selected BE issues in the hope of identifying common ground and arriving at a harmonized view on these topics.
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Harmonization of Regulatory Approaches for Evaluating Therapeutic Equivalence and Interchangeability of Multisource Drug Products: Workshop Summary Report
The AAPS Journal, 2011Co-Authors: Mei-ling Chen, Vinod P. Shah, Daan J. Crommelin, Leon Shargel, Dennis Bashaw, Masood Bhatti, Henning Blume, Jennifer Dressman, Murray Ducharme, Paul FacklerAbstract:Regulatory approaches for evaluating therapeutic equivalence of multisource (or generic) drug products vary among different countries and/or regions. Harmonization of these approaches may decrease the number of in vivo bioequivalence studies and avoid unnecessary drug exposure to humans. Global Harmonization for regulatory requirements may be promoted by a better understanding of factors underlying product performance and expectations from different regulatory authorities. This workshop provided an opportunity for pharmaceutical scientists from academia, industry and regulatory agencies to have open discussions on current regulatory issues and industry practices, facilitating Harmonization of regulatory approaches for establishing therapeutic equivalence and interchangeability of multisource drug products.
Mario Dominguez - One of the best experts on this subject based on the ideXlab platform.
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large molecule specific assay operation recommendation for best practices and Harmonization from the Global bioanalysis consortium Harmonization team
Aaps Journal, 2014Co-Authors: Lauren Stevenson, Marian Kelley, Boris Gorovits, Clare Kingsley, Heather Myler, Karolina Osterlund, Arumugam Muruganandam, Yoshiyuki Minamide, Mario DominguezAbstract:The L2 Global Harmonization Team on large molecule specific assay operation for protein bioanalysis in support of pharmacokinetics focused on the following topics: setting up a balanced validation design, specificity testing, selectivity testing, dilutional linearity, hook effect, parallelism, and testing of robustness and ruggedness. The team additionally considered the impact of lipemia, hemolysis, and the presence of endogenous analyte on selectivity assessments as well as the occurrence of hook effect in study samples when no hook effect had been observed during pre-study validation.