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[HTML][HTML] Advances in Therapeutic Peptides Separation and Purification
Peptides are gaining prominence in various fields, including the pharmaceutical industry. To
meet regulatory requirements, they must achieve a certain purity threshold to ensure safe …
meet regulatory requirements, they must achieve a certain purity threshold to ensure safe …
Impact of Impurities on the Quality and Safety of Oligonucleotides as Drug Substances
J Kaufmann, TM Rupp - 2024 - books.rsc.org
This chapter covers chemistry, manufacturing, and controls (CMC) aspects based on the
quality vision of synthetically manufactured oligonucleotides as active pharmaceutical …
quality vision of synthetically manufactured oligonucleotides as active pharmaceutical …
Oligopeptide Regulatory Affairs and Challenges
AJ Wolf, A Ricci - 2024 - books.rsc.org
In the USA, drugs and biologics are regulated under different regulatory pathways. Drugs
are approved under the Food and Drug and Cosmetic Act and the Food and Drug …
are approved under the Food and Drug and Cosmetic Act and the Food and Drug …