International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences

AAPS Journal

Volumn 17, Issue 3, 2015, Pages 546-557

  Lu, Dongmei ^a   Lee, Sau L ^a   Lionberger, Robert A ^a   Choi, Stephanie ^a   Adams, Wallace ^a   Caramenico, Hoainhon N ^a   Chowdhury, Badrul A ^a   Conner, Dale P ^a   Katial, Rohit ^b   Limb, Susan ^a   Peters, John R ^a   Yu, Lawrence ^a   Seymour, Sally ^a   Li, Bing V ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b DEPARTMENT OF MEDICINE   (United States)

Author keywords

bioequivalence; exhaled nitric oxide; generic; guidelines; orally inhaled drugs

Indexed keywords

DRUG; GENERIC DRUG;

EQUIPMENT DESIGN; HUMAN; INHALATIONAL DRUG ADMINISTRATION; INTERNATIONAL COOPERATION; NEBULIZER; PHARMACOKINETICS; PRACTICE GUIDELINE; STANDARDS; THERAPEUTIC EQUIVALENCE;

ADMINISTRATION, INHALATION; DRUGS, GENERIC; EQUIPMENT DESIGN; GUIDELINES AS TOPIC; HUMANS; INTERNATIONALITY; NEBULIZERS AND VAPORIZERS; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS; THERAPEUTIC EQUIVALENCY;

EID: 84936934323     PISSN: None     EISSN: 15507416     Source Type: Journal    
DOI: 10.1208/s12248-015-9733-9     Document Type: Article

References (17)

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