Discussion on Clinical Use and Technical Requirements of Scored Tablets / 中国药学杂志

ABSTRACT

OBJECTIVE: To discuss the technical requirements of scored tablets combining with the current situation of clinical use of scored tablets and the domestic and national technical requirements. METHODS: The FDA guidance on tablet scoring was introduced in detail, on this basis, the general considerations on the technical requirements of generic scored tablets were put forward. RESULTS: AND CONCLUSION: It was suggested that the evaluation criteria should be established on the basis of taking a full consideration on product characteristics in the process of research and development, scored tablets should be developed in accordance with clinical needs, and specification description should be standardized for clarifying the clinical use of the scored tablets.