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Specialty molecules from plants and in vitro cultures as new drugs: regulatory considerations from flask to patient.
Dou, Jinhui; Weathers, Pamela.
Afiliação
  • Dou J; Jiangsu Tripod Preclinical Research Laboratories Co. LTD, Nanjing, China.
  • Weathers P; Department of Biology and Biotechnology, Worcester Polytechnic Institute, 100 Institute Rd, Worcester, MA 01609 USA.
Plant Cell Tissue Organ Cult ; 149(1-2): 105-111, 2022.
Article em En | MEDLINE | ID: mdl-35345535
ABSTRACT
Few therapeutic specialty molecules from in vitro cultures beyond paclitaxel have come to market and although other more complex products like ginseng have also appeared, success has been limited. Often it is not the science that is limiting, but rather regulatory issues that limit considerations of potential products mainly because of costs in getting the product to market. Here we discuss broader thinking of such specialty molecules in the form of dietary supplements, nutraceuticals, herbal medicines, botanical drugs, and pure molecules along with potential complex products from a regulatory standpoint and especially within the realm of approved botanical drugs, e.g., Veregen and Fulyzaq, that have new drug applications (NDAs). The United States food and drug administration (US FDA) regulatory categories are used to provide examples of alternative product options that could prove useful for taking specialty molecules to market.
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Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2022 Tipo de documento: Article