The US and EU regulatory landscapes for locally acting generic/hybrid inhalation products intended for treatment of asthma and COPD

Journal of Aerosol Medicine and Pulmonary Drug Delivery

Volumn 25, Issue 4, 2012, Pages 243-247

  Fuglsang, Anders ^a  

^a Fuglsang Pharma   (Germany)

Author keywords

asthma; chronic obstructive pulmonary disease; COPD; Europe; guidelines; inhalation drugs; United States

Indexed keywords

GENERIC DRUG; ORCIPRENALINE; SALBUTAMOL;

ANALYSIS OF VARIANCE; AREA UNDER THE CURVE; ASTHMA; BIOEQUIVALENCE; CHRONIC OBSTRUCTIVE LUNG DISEASE; DRUG ABSORPTION; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG EXPOSURE; DRUG LEGISLATION; DRUG SAFETY; DRUG SCREENING; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL ABSORPTION; HUMAN; IN VITRO STUDY; MAXIMUM PLASMA CONCENTRATION; MEDICAL DOCUMENTATION; METERED DOSE INHALER; PARTICLE SIZE; PRACTICE GUIDELINE; PRODUCT SAFETY; REVIEW; SOLID STATE; UNITED STATES;

ADMINISTRATION, INHALATION; ASTHMA; DRUG AND NARCOTIC CONTROL; DRUGS, GENERIC; EUROPEAN UNION; GUIDELINES AS TOPIC; HUMANS; METERED DOSE INHALERS; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; UNITED STATES;

EID: 84864691570     PISSN: 19412711     EISSN: 19412703     Source Type: Journal    
DOI: 10.1089/jamp.2012.0970     Document Type: Review

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