Peptide therapy has become a key strategy in innovative drug development, however, one of the potential barriers for the development of novel peptide drugs in the clinic is their deficiencies in clearly defined chemistry, manufacturing and controls (CMC) strategy from clinical development to commercialization. CMC can often become a rate-limiting step due to lack of knowledge and lack of a formal policy or guidelines on CMC for peptide-based drugs. Regulators use a risk-based appr...
قائمة المحتويات
Regulatory Considerations for Peptide Therapeutics; Regulatory Perspective on Synthetic Peptides in Europe; Biological and Immunogenicity Evaluation Strategy for The...
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لغة الإنجليزية ● شكل PDF ● صفحات 543 ● ISBN 9781788016445 ● حجم الملف 10.9 MB ● محرر Ved Srivastava ● الناشر Royal Society of Chemistry ● نشرت 2019 ● الإصدار 1 ● للتحميل 24 الشهور ● دقة EUR ● هوية شخصية 7181185 ● حماية النسخ Adobe DRM
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