Peptide therapeutics : strategy and tactics for chemistry, manufacturing, and controls [E-Book] / editor: Ved Srivastava.
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 commerc...
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Full text |
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Personal Name(s): | Srivastava, Ved, editor |
Imprint: |
Cambridge :
Royal Society of Chemistry,
2019
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Physical Description: |
1 online resource (544 pages) |
Note: |
englisch |
ISBN: |
9781788014335 9781788016445 1788016440 |
Series Title: |
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RSC drug discovery series ;
72 |
Subject (LOC): |
- Regulatory Considerations for Peptide Therapeutics
- Regulatory Perspective on Synthetic Peptides in Europe
- Biological and Immunogenicity Evaluation Strategy for Therapeutic Peptides: Chemistry, Manufacturing and Controls Perspective
- Chemistry, Manufacturing and Controls: Active Pharmaceutical Ingredient and Drug Product
- Peptide Manufacturing Methods and Challenges
- Economic and Environmental Factors Affecting the Sustainability of Peptide Therapeutic Manufacturing
- A Holistic Quality Control Strategy for Peptide Active Pharmaceutical Ingredients (APIs)
- Higher-order Structure Characterization and Comparability Assessments for Peptides
- Impurity Characterization and Quantification by Liquid Chromatography–High-resolution Mass Spectrometry
- Mass Spectrometric Analysis for the Quality Control of Peptide Conjugate Therapeutics
- Determination of the Identity, Content and Purity of Therapeutic Peptides by NMR Spectroscopy
- Transport, Stability and Delivery Considerations for the Design of Peptide Drugs
- Assessing the Impact of Functional Excipients on Peptide Drug Product Attributes During Pharmaceutical Development
- Formulations of Microspheres and Nanoparticles for Peptide Delivery