关键词：医药；共晶药品；制药业；药物评价
摘 要：This guidance provides applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with the Center for Drug Evaluation and Research's current thinking on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. This guidance also provides information about the data that you, the applicant, should submit to support the appropriate classification of a co-crystal, as well as the regulatory implications of the classification. The recommendations in this guidance apply to materials that the Agency has not previously evaluated and determined to be pharmaceutical co-crystals. The recommendations do not apply to materials that the Agency has previously designated as salts, complexes, or other non-co-crystalline forms.