Impurities in Oligonucleotide Drug Substances and Drug Products
| Autor: | Samantha Gao-Sheridan, Neal Sharpe, Brigitte Burm, Jeffrey W.-D. Foy, Andy Teasdale, Daniel C. Capaldi, Scott P. Henry, Cathaline den Besten, Matthias Kretschmer, Nadim Akhtar, Ben Andrews |
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| Rok vydání: | 2017 |
| Předmět: |
Male
0301 basic medicine Drug Drug Industry Chemistry Pharmaceutical media_common.quotation_subject Oligonucleotides Pharmacology 01 natural sciences Biochemistry Chemistry Techniques Analytical Mice 03 medical and health sciences Limit of Detection Drug Discovery Genetics Animals Humans Molecular Biology media_common Oligonucleotide 010401 analytical chemistry 0104 chemical sciences 030104 developmental biology Drug Design Models Animal Molecular Medicine Female Patient Safety Biochemical engineering Drug Contamination |
| Zdroj: | Nucleic Acid Therapeutics. 27:309-322 |
| ISSN: | 2159-3345 2159-3337 |
| Popis: | This white paper, which is the 10th in a series intended to address issues associated with the development of therapeutic oligonucleotides, examines the subject of product-related impurities. The authors consider chemistry and safety aspects and advance arguments in favor of platform approaches to impurity identification and qualification. Reporting, identification, and qualification thresholds suitable for product-related impurities of therapeutic oligonucleotides are proposed. |
| Databáze: | OpenAIRE |
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