Work

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

Year: 2015

Type: article

Source: The AAPS Journal

DOI: 10.1208/s12248-015-9787-8

Authors: Sau L. Lee, Bhawana Saluja, Alfredo García-Arieta, Gustavo Mendes Lima Santos, Ying Li, Sarah Lu, Shuguang Hou, Juliet Rebello, Abhijit Vaidya, Jaideep Gogtay, Shrinivas Purandare, Svetlana Lyapustina

Institutions: United States Food and Drug Administration, Center for Drug Evaluation and Research, Agência Nacional de Vigilância Sanitária, Merck & Co., Inc., Rahway, NJ, USA (United States), Cipla (India)

Language: English

Topic: Inhalation and Respiratory Drug Delivery

Subfield: Pulmonary and Respiratory Medicine

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: green

OpenAlex ID: W337842491

FWCI: 3.548

Cites: 40

Cited by: 71

Related to: 10