The Experts below are selected from a list of 15 Experts worldwide ranked by ideXlab platform
Ahmed Zayed - One of the best experts on this subject based on the ideXlab platform.
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fucoidan Production Approval key challenges and opportunities
Carbohydrate Polymers, 2019Co-Authors: Ahmed Zayed, Roland UlberAbstract:Fucoidan has gained a great interest as a potential drug candidate against various diseases including anti-coagulant, anti-viral and anti-tumors activities. However, several challenges have hampered fucoidan to be a GMP-compliant product and then FDA Approval. This review discussed fucoidan structure's heterogeneity, co-extracted contaminants, and ecological-related problems, which were considered as the major challenges faced fucoidan Approval. Moreover, it presented novel opportunities toward homogenous Production that gives high-quality, reliable and reproducible physico-chemical and clinical results. Among these opportunities are optimization of extraction and purification procedures, tissue culture techniques and enzymatic synthesis via heterologous expression of enzymes involved in its biosynthesis.
Roland Ulber - One of the best experts on this subject based on the ideXlab platform.
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fucoidan Production Approval key challenges and opportunities
Carbohydrate Polymers, 2019Co-Authors: Ahmed Zayed, Roland UlberAbstract:Fucoidan has gained a great interest as a potential drug candidate against various diseases including anti-coagulant, anti-viral and anti-tumors activities. However, several challenges have hampered fucoidan to be a GMP-compliant product and then FDA Approval. This review discussed fucoidan structure's heterogeneity, co-extracted contaminants, and ecological-related problems, which were considered as the major challenges faced fucoidan Approval. Moreover, it presented novel opportunities toward homogenous Production that gives high-quality, reliable and reproducible physico-chemical and clinical results. Among these opportunities are optimization of extraction and purification procedures, tissue culture techniques and enzymatic synthesis via heterologous expression of enzymes involved in its biosynthesis.
Arnon D. Cohen - One of the best experts on this subject based on the ideXlab platform.
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biosimilars for psoriasis worldwide overview of regulatory guidelines uptake and implications for dermatology clinical practice
British Journal of Dermatology, 2017Co-Authors: Ricardo Romiti, L Puig, Ronald Vender, Jashin J. Wu, Arnon D. Cohen, Sergio Chimenti, M. Rajagopalan, C. Cruz, Lone SkovAbstract:The introduction of biologic drugs for the treatment of patients with psoriasis has revolutionized treatment paradigms and enabled numerous patients to achieve disease control with an acceptable safety profile. However, the high cost of biologics limits access to these medications for the majority of patients worldwide. In recent years, the introduction of biosimilars for inflammatory diseases has become a fast evolving field. The future use of biosimilars offers the potential for decreased cost and increased access to biologic drugs for patients with psoriasis. For their Approval, different regulatory agencies use highly variable methods for definition, Production, Approval, marketing, and post-marketing surveillance of biosimilars. Due to potential interchangeability between biologics and biosimilars, traceability and pharmacovigilance are required to collect accurate data about adverse events in psoriasis patients; spontaneous reporting, registries, and use of “big data” should facilitate this process on a global basis. The current article describes biosimilar regulatory guidelines and examples of biosimilar uptake in clinical practice in several countries around the world. As it is apparent that biologic treatment decisions may become more physician-independent, the International Psoriasis Council recommends that dermatologists should take an active role in the development of biosimilar prescribing policies with their respective healthcare settings and governmental agencies. This article is protected by copyright. All rights reserved.
Lone Skov - One of the best experts on this subject based on the ideXlab platform.
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biosimilars for psoriasis worldwide overview of regulatory guidelines uptake and implications for dermatology clinical practice
British Journal of Dermatology, 2017Co-Authors: Ricardo Romiti, L Puig, Ronald Vender, Jashin J. Wu, Arnon D. Cohen, Sergio Chimenti, M. Rajagopalan, C. Cruz, Lone SkovAbstract:The introduction of biologic drugs for the treatment of patients with psoriasis has revolutionized treatment paradigms and enabled numerous patients to achieve disease control with an acceptable safety profile. However, the high cost of biologics limits access to these medications for the majority of patients worldwide. In recent years, the introduction of biosimilars for inflammatory diseases has become a fast evolving field. The future use of biosimilars offers the potential for decreased cost and increased access to biologic drugs for patients with psoriasis. For their Approval, different regulatory agencies use highly variable methods for definition, Production, Approval, marketing, and post-marketing surveillance of biosimilars. Due to potential interchangeability between biologics and biosimilars, traceability and pharmacovigilance are required to collect accurate data about adverse events in psoriasis patients; spontaneous reporting, registries, and use of “big data” should facilitate this process on a global basis. The current article describes biosimilar regulatory guidelines and examples of biosimilar uptake in clinical practice in several countries around the world. As it is apparent that biologic treatment decisions may become more physician-independent, the International Psoriasis Council recommends that dermatologists should take an active role in the development of biosimilar prescribing policies with their respective healthcare settings and governmental agencies. This article is protected by copyright. All rights reserved.
James R Jackson - One of the best experts on this subject based on the ideXlab platform.
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re commingled Production Approval
2006Co-Authors: James R JacksonAbstract:1. Production from the Notikewin (870.5-873.5 mKB) and Gething (1098.0 – 1150.0 mKB) zones may be commingled. 2. Gas, condensate and water Production should be allocated on the Ministry of Small Business and Revenue BC S-1 and BC S-2 forms on the basis of Notikewin 20% and Gething 80%. 3. This Approval may be modified at a later date if deemed appropriate through a change in circumstances. Should you have any questions, please contact the undersigned at (250) 952-0366. Sincerely,
