Výsledky vyhledávání - "generic peptides"

US FDA Regulatory Framework for Generic Peptides Referring to rDNA Origin Reference Products

Autor: Swanand Pathak, Deepak Khobragade, Ankit Chincholkar

Publikováno v: Journal of Pharmaceutical Research International. :44-49

Peptides are polymeric molecules having 40 or less amino acids. Peptides have been used as therapeutic compounds for the treatment of various disorders since 1920s. Initially, these were isolated from animals. Currently, most of the therapeutic pepti

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::c5eb5285053b70ce84e62c4561fe5bbc
https://doi.org/10.9734/jpri/2022/v34i41a36276

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GMP Production of Generic Peptides. Where is it Going?

Autor: Jordi Bacardit-Cabado

Publikováno v: International Journal of Peptide Research and Therapeutics. 13:69-73

The paper discusses different aspects of the manufacturing of peptides as active pharmaceutical ingredients under compliance to Good Manufacturing Practices. It focuses attention on the possibilities of production relocation for such molecules to eme

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::0ec6acbfb7da5b1501e48e6bcc9a3cb0
https://doi.org/10.1007/s10989-007-9081-4

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The Effects of pH and Excipients on Exenatide Stability in Solution

Autor: Alexander Benet, Troy Halseth, Jukyung Kang, April Kim, Rose Ackermann, Santhanakrishnan Srinivasan, Steven Schwendeman, Anna Schwendeman

Publikováno v: Pharmaceutics, Vol 13, Iss 8, p 1263 (2021)

Exenatide, a glucagon-like peptide-1 receptor agonist, is the active pharmaceutical ingredient in Byetta® and Bydureon®, two type 2 diabetes drug products that have generics and multiple follow-up formulations currently in development. Even though

Externí odkaz: https://doaj.org/article/cfdddcbf97ef416498e9b3f921369de4

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Generic peptide drugs: characterization methods and sameness evaluation

Autor: Bernatović, Katarina

Peptidni lijekovi i njihov široki terapijski potencijal postali su dostupniji općoj populaciji dolaskom generičkih peptidnih lijekova na tržište. Usprkos tome što ne postoje opće harmonizirane zakonske smjernice za proizvodnju i kontrolu kvali

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=od______3671::0dedc140f9ca7ad43ad80075270583e6
https://repozitorij.pharma.unizg.hr/islandora/object/pharma:1978/datastream/PDF