Review of global regulations concerning biowaivers for immediate release solid oral dosage forms

European Journal of Pharmaceutical Sciences

Volumn 29, Issue 3-4 SPEC. ISS., 2006, Pages 315-324

  Gupta, E ^a   Barends, D M ^b   Yamashita, E ^a   Lentz, K A ^a   Harmsze, A M ^c   Shah, V P ^d   Dressman, J B ^e   Lipper, R A ^a  

^a BRISTOL MYERS SQUIBB PHARMACEUTICAL RESEARCH INSTITUTE   (United States)

^b NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

^c ST ANTONIUS HOSPITAL   (Netherlands)

^d JW Goethe University ^*

^e GOETHE UNIVERSITY   (Germany)

Author keywords

Biopharmaceutics Classification System (BCS); Regulations

Indexed keywords

DRUG ADDITIVE; MANNITOL; SOTALOL;

BIOAVAILABILITY; BIOEQUIVALENCE; DRUG DOSAGE FORM; DRUG FORMULATION; DRUG MARKETING; DRUG POTENCY; DRUG RELEASE; DRUG SOLUBILITY; JAPAN; PHYSICAL CHEMISTRY; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; TABLET FORMULATION; UNITED STATES; WORLD HEALTH ORGANIZATION;

EID: 33750161035     PISSN: 09280987     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejps.2006.05.001     Document Type: Review

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