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Editorial

Manufacturing classification system (MCS): enabling better understanding of oral solid dosage formulation design

Received 07 May 2024, Accepted 08 May 2024, Published online: 21 May 2024

References

  • Leane M, Pitt K, Reynolds G, Tantuccio A, Moreton C, Crean A, Kleinebudde P, Carlin B, Gamble J, Gamlen M, et al. 2024. Ten years of the manufacturing classification system: a review of literature applications and an extension of the framework to continuous manufacture. Pharmaceut Develop Technol. 1–20. (Apr 15): doi:10.1080/10837450.2024.2342953.
  • Leane M, Pitt K, Reynolds G, M. C. S. W. Group. 2015. A proposal for a drug product manufacturing classification system (MCS) for oral solid dosage forms. Pharmaceut Develop Technol. 20(1):12–21. doi:10.3109/10837450.2014.954728.
  • Leane, M., K. Pitt, G. K. Reynolds, N. Dawson, I. Ziegler, A. Szepes, A. M. Crean, R. D. Agnol, B. Broegmann, S. T. Charlton, et al. and M. C. S. W. Grp (2018). “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.” Pharmaceut Develop Technol. 23(10): 964–977. doi:10.1080/10837450.2018.1534863.

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