Building parity between brand and generic peptide products: Regulatory and scientific considerations for quality of synthetic peptides

Author:

Wu Larisa C.,Chen Fu,Lee Sau L.,Raw Andre,Yu Lawrence X.

Funder

Office of Pharmaceutical Quality/Center for Drug Evaluation and Research, U.S. Food and Drug Administration

U.S. Department of Energy

FDA

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference154 articles.

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3. Compatibility of osmolytes with Gibbs energy of stabilization of proteins;Anjum;Biochimica Et Biophysica Acta-Protein Struct. Mol. Enzymol.,2000

4. Amino-acids and peptides. 25. mechanism of base-catalysed racemisation of P-nitrophenyl esters of acylpeptides;Antonovi;J. Chem. Soc. C-Org.,1967

5. Shear-induced unfolding of lysozyme monitored In situ;Ashton;Biophys. J .,2009

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