API co-crystals – Trends in CMC-related aspects of pharmaceutical development beyond solubility

Author:

Becker Axel

Publisher

Elsevier BV

Subject

Drug Discovery,Pharmacology

Reference58 articles.

1. An industrial perspective on co-crystals: screening identification and development of the less utilised solid form in drug discovery and development;Kendall;Progress in Medicinal Chemistry,2021

2. European Medicines Agency. Reflection paper on the use of cocrystals and other solid state forms of active substances in medicinal products. EMA/CHMP/CVMP/QWP/284008/2015. May 2015.

3. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Regulatory Classification of Pharmaceutical Co-Crystals Guidance for Industry. Pharmaceutical Quality/CMC, February 2018, Revision 1.

4. A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms;Leane;Pharm Dev Technol,2015

5. Manufacturing classification system in the real world: factors influencing manufacturing process choices for filed commercial oral solid dosage formulations, case studies from industry and considerations for continuous processing;Leane;Pharm Dev Technol,2018

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