The new european medicines agency guideline on the investigation of bioequivalence

Basic and Clinical Pharmacology and Toxicology

Volumn 106, Issue 3, 2010, Pages 221-225

  Morais, José Augusto Guimarães ^a,b   Lobato, Maria Do Rosário ^a,b  

^a RESEARCH INSTITUTE FOR MEDICINES IMED ULISBOA   (Portugal)

^b INFARMED)   (Portugal)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG METABOLITE; EXCIPIENT; GENERIC DRUG;

ANALYTICAL PARAMETERS; BIOAVAILABILITY; BIOEQUIVALENCE; CONFERENCE PAPER; DIET RESTRICTION; DRUG DOSAGE FORM; DRUG EFFICACY; DRUG FORMULATION; DRUG HALF LIFE; DRUG LEGISLATION; DRUG MARKETING; DRUG QUALITY; DRUG RELEASE; DRUG SAFETY; DRUG SCREENING; DRUG SOLUBILITY; EUROPE; FOOD INTAKE; HUMAN; LIPOSOMAL DELIVERY; PARALLEL DESIGN; PRACTICE GUIDELINE; PREDICTION; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; RISK BENEFIT ANALYSIS; STANDARD; STEADY STATE;

BIOLOGICAL AVAILABILITY; CLINICAL TRIALS AS TOPIC; DRUGS, GENERIC; EUROPE; GOVERNMENT AGENCIES; PRACTICE GUIDELINES AS TOPIC; RESEARCH DESIGN; THERAPEUTIC EQUIVALENCY;

EID: 77149175632     PISSN: 17427835     EISSN: 17427843     Source Type: Journal    
DOI: 10.1111/j.1742-7843.2009.00518.x     Document Type: Conference Paper

References (6)

1. Note for Guidance on the Investigation of Bioavailability and Bioequivalence (NfG on BA/BE), CPMP/EWP/QWP/1401/98.
2. Drug Bioequivalence. A Report of the Office of Technology Assessment. Drug Bioequivalence Study Panel, July 1974, NTIS (USA).
3. European Guideline. Investigation of Bioavailability and Bioequivalence, The Rules Governing Medicinal Products in the European Union, June 1992.
4. Questions & Answers on the Note for Guidance on the Investigation of Bioavailability and Bioequivalence, EMEA/CHMP/EWP/40326/2006.
5. Directive 2001/83/EC as amended by Parliament and Council Directive 2004/27.
6. Notice to Applicants, Volume 2A, Procedures for Marketing Authorisation, Chapter 1, European Commission, ENTR/F2/BL D(2002), rev. 3.