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

AAPS Journal

Volumn 17, Issue 5, 2015, Pages 1285-1304

  Lee, Sau L ^a   Saluja, Bhawana ^a   García Arieta, Alfredo ^b   Santos, Gustavo Mendes Lima ^c   Li, Ying ^d   Lu, Sarah ^e   Hou, Shuguang ^f   Rebello, Juliet ^g   Vaidya, Abhijit ^g   Gogtay, Jaideep ^g   Purandare, Shrinivas ^h   Lyapustina, Svetlana ^i,j  

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

^b Department of Human Use Medicines   (Spain)

^c Agencia Nacional de Vigilancia Sanitaria Brazil   (Brazil)

^d MERCK RESEARCH LABORATORIES   (United States)

^e Regulatory Affairs ^*  (China)

^f Sichuan Tianhu Plasma Technology Co Ltd   (China)

^g Clinical Research Division   (India)

^h Regulatory Affairs   (India)

ⁱ Pharmaceutical Practice Group DBR   (United States)

^j Drinker Biddle and Reath LLP   (United States)

more..

Author keywords

bioequivalence; emerging markets; generics; pMDIs and DPIs; regulatory requirements

Indexed keywords

BECLOMETASONE DIPROPIONATE; BETA 2 ADRENERGIC RECEPTOR STIMULATING AGENT; BETA ADRENERGIC RECEPTOR STIMULATING AGENT; BRONCHODILATING AGENT; BUDESONIDE; CHOLINERGIC RECEPTOR BLOCKING AGENT; CICLESONIDE; CORTICOSTEROID; FLUTICASONE; FLUTICASONE PROPIONATE; FLUTICASONE PROPIONATE PLUS SALMETEROL; GENERIC DRUG; LONG ACTING DRUG; SALBUTAMOL; SALMETEROL; SALMETEROL XINAFOATE; SHORT ACTING DRUG;

AERODYNAMIC PARTICLE SIZE DISTRIBUTION; AREA UNDER THE CURVE; ARTICLE; ASTHMA; BIOEQUIVALENCE; BRAZIL; CHINA; CHRONIC OBSTRUCTIVE LUNG DISEASE; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG SOLUBILITY; DRY POWDER INHALER; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; FORCED EXPIRATORY VOLUME; HUMAN; INDIA; MAXIMUM PLASMA CONCENTRATION; MEDICAL PARAMETERS; MEDICAL RESEARCH; METERED DOSE INHALER; MULTICENTER STUDY (TOPIC); NEBULIZER; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); TIME TO MAXIMUM PLASMA CONCENTRATION; UNITED STATES; INHALATIONAL DRUG ADMINISTRATION; LEGISLATION AND JURISPRUDENCE; MEDICINAL CHEMISTRY; THERAPEUTIC EQUIVALENCE;

ADMINISTRATION, INHALATION; CHEMISTRY, PHARMACEUTICAL; DRUG APPROVAL; DRUGS, GENERIC; HUMANS; THERAPEUTIC EQUIVALENCY;

EID: 84939572291     PISSN: None     EISSN: 15507416     Source Type: Journal    
DOI: 10.1208/s12248-015-9787-8     Document Type: Article

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