Live Biotherapeutic Products, A Road Map for Safety Assessment
نویسندگان
چکیده
منابع مشابه
Development of Phage Lysin LysA2 for Use in Improved Purity Assays for Live Biotherapeutic Products
Live biotherapeutic products (LBPs), commonly referred to as probiotics, are typically preparations of live bacteria, such as Lactobacillus and Bifidobacterium species that are considered normal human commensals. Popular interest in probiotics has been increasing with general health benefits being attributed to their consumption, but there is also growing interest in evaluating such products fo...
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Regarding a letter by Erika Lietzan (1) addressing our article on regulating biotechnology drugs in Colombia (2), we offer the following response. As Lietzan states, it is true that there is a global consensus on the two regulatory pathways to obtaining market authorization for biological medicines: the full dossier pathway for pioneer products and an abbreviated pathway for competitors (biosim...
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ژورنال
عنوان ژورنال: Frontiers in Medicine
سال: 2020
ISSN: 2296-858X
DOI: 10.3389/fmed.2020.00237