Regulatory science of natural products

Goda, Yukihiro

doi:10.1007/s11418-022-01639-w

Cited by 6 publications

(3 citation statements)

References 105 publications

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“…Its prescription to obese patients is not at all recommended [177]. These considerations have prompted the development of ephedrine alkaloid-free Ephedra herb extracts [21,24,178]. Beyond flavonoids and alkaloids, Ephedra extracts also contain useful terpenoids, carboxylic acids, tannins, and other types of constituents such as unsaturated fatty acids [55,97,179,180].…”

Section: Discussionmentioning

confidence: 99%

Ethnobotanical Uses and Pharmacological Activities of Moroccan Ephedra Species

Chroho,

Bailly,

Bouissane

2024

Planta Med

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Ephedra species are among the most popular herbs used in traditional medicine for a long time. The ancient Chinese medical book “Treatise on Febrile Diseases” refers to the classic traditional Chinese medicine prescription Ge Gen decoction, which consists of seven herbs, including an Ephedra species. Ephedra species are utilized all over the world to treat symptoms of the common cold and coughs, and to combat major human diseases, such as asthma, cancers, diabetes, cardiovascular and digestive disorders, and microbial infections. This study aimed at identifying specific Ephedra species used traditionally in Morocco for therapeutic purposes. The plant parts, their preparation process, and the treated pathologies were identified and analyzed. The results revealed five ethnobotanically important species of Ephedra: Ephedra alata Decne, Ephedra altissima Desf., Ephedra distachya L., Ephedra fragilis Desf., and Ephedra nebrodensis Tineo. These species are used traditionally in Morocco for treating people with diabetes, cancer, rheumatism, cold and asthma, hypertension, influenza virus infection, and respiratory ailments. In addition, they are occasionally used as calefacient agents, to regulate weight, or for capillary care. Few studies have underlined the antibacterial and antioxidant activities of some of these Moroccan Ephedra species, but little information is available regarding the natural products at the origin of the bioactivities. Further phytochemical investigations and clinical data are encouraged to better support the use of these plants.

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Section: Discussionmentioning

confidence: 99%

Ethnobotanical Uses and Pharmacological Activities of Moroccan Ephedra Species

Chroho,

Bailly,

Bouissane

2024

Planta Med

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“…Por lo tanto, es esencial que el público, incluidos los profesionales de la salud, reciba suficiente información para ayudar a comprender mejor los riesgos asociados con el uso de estos productos y garantizar que todos sean seguros y de calidad adecuada. (Ekor, 2014;Goda, 2022;Heydari et al, 2022;Zhang et al, 2016;Zhao et al, 2014).…”

Section: Introductionunclassified

Agrárias: Pesquisa e Inovação nas Ciências que Alimentam o Mundo IX

Spers¹

2023

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O conteúdo deste livro está licenciado sob uma Licença de Atribuição Creative Commons Atribuição-Não-Comercial NãoDerivativos 4.0 Internacional (CC BY-NC-ND 4.0). Direitos para esta edição cedidos à Editora Artemis pelos autores. Permitido o download da obra e o compartilhamento, desde que sejam atribuídos créditos aos autores, e sem a possibilidade de alterá-la de nenhuma forma ou utilizá-la para fins comerciais.A responsabilidade pelo conteúdo dos artigos e seus dados, em sua forma, correção e confiabilidade é exclusiva dos autores. A Editora Artemis, em seu compromisso de manter e aperfeiçoar a qualidade e confiabilidade dos trabalhos que publica, conduz a avaliação cega pelos pares de todos manuscritos publicados, com base em critérios de neutralidade e imparcialidade acadêmica.

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“…In addition, a research project on the harmonization and evaluation of regulations for pharmaceuticals and medical devices by the Japan Agency for Medical Research and Development has taken regulatory consideration of the shared data and information required for interoperable medical devices ( 11 ). Japanese scholars summarized the development experience of the ethical Kampo products with new dosage forms and herbal medicines that used Kampo extracts as active pharmaceutical ingredients, illustrating the importance of RS for the development of new drugs for natural products ( 12 ).…”

Section: Introductionmentioning

confidence: 99%

Application of implementation science framework to develop and adopt regulatory science in different national regulatory authorities

Shi

Chen

et al. 2023

Front. Public Health

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IntroductionThe purpose of developing and adopting regulatory science (RS) for drug regulatory authorities (DRAs) is to enhance regulatory capacity by advancing the scientific approach for the evaluation of health-related products. While many DRAs around the world advocate the concept of RS, the implementation approaches of RS vary according to local needs and have not been systemically examined. This study aimed to systematically identify the evidence about how RS was developed, adopted, and advanced by the selected DRAs, and analyzed and compared the implementation experiences of RS development under the guidance of an implementation science framework.MethodsDocumentary analysis of government documents and a scoping literature review were conducted, and data analysis was performed under the guidance of the PRECEDE-PROCEED Model (PPM). DRAs in the United States, the European Union, Japan, and China had officially launched RS initiatives and were therefore selected as the target countries in this study.ResultsThere is no common consensus on the definition of RS among the DRAs. However, these DRAs shared the same goal of developing and adopting RS, which was used to develop new tools, standards, and guidelines that could improve the effectiveness and efficiency of the risk and benefit assessment of the regulated products. Each DRA had decided its own priority areas for RS development and thus set specific objectives that might be technology-based (e.g., toxicology and clinical evaluation), process-based (e.g., partnership with healthcare systems and high-quality review/consultation services), or product-based (e.g., drug-device combination products and innovative emerging technologies). To advance RS, considerable resources had been allocated for staff training, advancing information technology and laboratory infrastructure, and funding research projects. DRAs also took multifaceted approaches to expand scientific collaborations through public–private partnerships, research funding mechanisms, and innovation networks. Cross-DRA communications were also reinforced through horizon scanning systems and consortiums to better inform and assist the regulatory decision-making process. The output measurements might be scientific publications, funded projects, DRAs interactions, and evaluation methods and guidelines. Improved regulatory efficiency and transparency leading to benefits to public health, patient outcomes, and translation of drug research and development as the key primary outcomes of RS development were anticipated but not yet clearly defined.ConclusionThe application of the implementation science framework is useful for conceptualizing and planning the development and adoption of RS for evidence-based regulatory decision-making. Continuous commitment to the RS development and regular review of the RS goals by the decision-makers are important for DRAs to meet the ever-changing scientific challenges in their regulatory decision-making process.

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Regulatory science of natural products

Cited by 6 publications

References 105 publications

Ethnobotanical Uses and Pharmacological Activities of Moroccan Ephedra Species

Ethnobotanical Uses and Pharmacological Activities of Moroccan Ephedra Species

Agrárias: Pesquisa e Inovação nas Ciências que Alimentam o Mundo IX

Application of implementation science framework to develop and adopt regulatory science in different national regulatory authorities

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