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CDE releases' Guidelines for Bioequivalence Study of Oral Inhalation Generic Drugs', suggesting providing spray characteristics
Date: 2020-12-23Read: 3

The Drug Evaluation Center of the National Medical Products Administration recently officially released the "Guiding Principles for Bioequivalence Research of Oral Inhalation Generic Drugs". In the evaluation method of pharmaceutical research on inhaled aerosols, it is clearly put forward that "it is recommended to provide research data on injection characteristics (such as spray mode, spray geometry, etc.)".

The full text of the "Guidelines for Bioequivalence Study of Generic Drugs for Oral Inhalation Preparations" can be found in the attachment

As the inventor of the laser image method to determine spray mode and spray geometry (spray shape), Proveris Science expects to promote the further development and expansion of oral and nasal inhalation preparations in China together with Chinese regulatory agencies and pharmaceutical enterprises through the official promulgation of regulations.

Shanghai Liangtong Industrial Co., Ltd. is the general agent of Proveris Science Company's products in China. If you have any needs or suggestions, please contact us or visit the Proveris website.