The Science and Regulations of Naturally Derived Complex Drugs

• Συγγραφή απο Οργανισμό/Αρχή: SpringerLink (Online service)
• Άλλοι συγγραφείς: Sasisekharan, Ram (Επιμελητής έκδοσης, http://id.loc.gov/vocabulary/relators/edt), Lee, Sau L. (Επιμελητής έκδοσης, http://id.loc.gov/vocabulary/relators/edt), Rosenberg, Amy (Επιμελητής έκδοσης, http://id.loc.gov/vocabulary/relators/edt), Walker, Larry A. (Επιμελητής έκδοσης, http://id.loc.gov/vocabulary/relators/edt)
• Μορφή: Ηλεκτρονική πηγή Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Cham : Springer International Publishing : Imprint: Springer, 2019.
• Έκδοση: 1st ed. 2019.
• Σειρά: AAPS Advances in the Pharmaceutical Sciences Series, 32
• Θέματα: Pharmaceutical technology.; Pharmacy.; Pharmaceutical Sciences/Technology.

This volume in the AAPS Advances series covers various quality, safety and clinical aspects of drug development that are relevant to new and/or generic drugs containing a complex mixture of molecules. Specific topics discussed include: raw materials sourcing; manufacturing controls; characterization...

Πίνακας περιεχομένων:

• Evolving Challenges in Developing Naturally-Derived Complex Mixtures into Drugs: U.S. Experience and Perspective
• Regulatory Landscapes for Approval of Naturally-derived Complex Mixture Drugs
• Complex Natural Product Heparin: Biosynthesis, Biology and Application via Synthetic Heparins
• Traditional Chinese Medicine Herbal Drugs: From Heritage to Future Developments
• Analytics on Farm-Dust Extract for Development of Novel Strategies to Prevent Asthma and Allergic Disease
• Analytical Tools for Physicochemical Characterization and Fingerprinting
• NMR in the Characterization of Complex Mixture Drugs
• Mass Spectrometry in the Characterization of Complex Drugs
• Scientific Considerations in the Approval of Complex Generi
• Raw Materials Production and Manufacturing Process Control Strategies
• Heparin Contamination and Issues Related to Raw Materials and Controls
• Pharmacology and Toxicology Concerns of Impurities
• Immunogenicity risks for Naturally Derived Complex Drugs
• Development of Plant-Derived Mixtures as Botanical Drugs: Clinical Considerations
• A Totality-of-Evidence Approach to Ensuring Therapeutic Consistency of Naturally Derived Complex Mixtures
• Economic Considerations for Complex Mixture Drugs
• Drug Discovery from Complex Mixtures: Serendipity, Screening and Characterization
• Integrated Approach for Characterization of Highly Heterogeneous Drugs. .