Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India

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Author/s:Lee, Sau; Saluja, Bhawana; Garcia Arieta, Alfredo; Santos, Gustavo; Li, Ying; Lu, Sarah; Hou, Shuguang; Rebello, Juliet; Vaidya, Abhijit; Gogtay, Jaideep; Purandare, Shrinivas; Lyapustina, Svetlana

Date:07/07/2005

Journal:AAPS J

DOI:10.1208/s12248-015-9787-8