BIOEQUIVALENCE;
DRUG EFFICACY;
DRUG LEGISLATION;
DRUG MARKETING;
DRUG QUALITY;
DRUG SAFETY;
EUROPEAN UNION;
PHARMACEUTICAL CARE;
REVIEW;
RISK BENEFIT ANALYSIS;
ADOLESCENT;
ADULT;
ATTITUDE OF HEALTH PERSONNEL;
AUSTRIA;
COST CONTROL;
CROSS-OVER STUDIES;
DOSE-RESPONSE RELATIONSHIP, DRUG;
DRUG APPROVAL;
DRUG COSTS;
DRUG TOXICITY;
DRUGS, GENERIC;
EUROPEAN UNION;
FEMALE;
HUMANS;
MALE;
MIDDLE AGED;
NATIONAL HEALTH PROGRAMS;
RANDOMIZED CONTROLLED TRIALS AS TOPIC;
RISK ASSESSMENT;
THERAPEUTIC EQUIVALENCY;
TREATMENT OUTCOME;
Aetna, InteliHealth, Information provided by Harvard Medical School. (Zugriff 14.1.2007)
Aspirin Timeline Great Moments in Aspirin's History (2006) Aetna, InteliHealth, Information provided by Harvard Medical School. www.intelihealth.com/IH/ihtIH/WSIHW000/8059/23707/237089.html?d=dmtContent (Zugriff 14.1.2007)
Richtlinie 2004/27/EG des Europäischen Parlaments und des Rates zur Änderung der Richtlinie 2001/83/EG zur Schaffung eines Gemeinschaftskodexes für Humanarzneimittel (31. März 2004)
Bundesgesetz vom 2. März 1983 über die Herstellung und das Inverkehrbringen von Arzneimitteln (Arzneimittelgesetz) StF: BGBl. Nr. 185/1983 Änderung BGBl. I Nr. 153/2005
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
International Conference on Harmonisation (ICH) of Technical Requirements for registration of Pharmaceuticals for Human Use (Oktober 2006) Leitlinie Q3A (R2) www.ich.org/LOB/media/MEDIA422.pdf (Zugriff 25.5.2007)
International Conference on Harmonisation (ICH) of Technical Requirements for registration of Pharmaceuticals for Human Use (June 2006) Leitlinie Q3B(R2) www.ich.org/LOB/media/MEDIA421.pdf (Zugriff 25.5.2007)
The European Agency for the Evaluation of Medicinal Products CPMP/EWP/QWP/1401/98 (26. July)
The European Agency for the Evaluation of Medicinal Products CPMP/EWP/QWP/1401/98 (26. July 2001) Note for guidance on the investigation of bioavailability and bioequivalence
Are the requirements in the bioequivalence guidelines strict enough to ascertain interchangeability with narrow therapeutic index drugs?
Thirstrup S (2007) Are the requirements in the bioequivalence guidelines strict enough to ascertain interchangeability with narrow therapeutic index drugs? Speech 19th Annual DIA Euro Meeting
Electronic Orange Book Approved Drug Products with Therapeutic Equivalence Evaluations Current through April 2007. www.fda.gov/cder/ob/default. htm (Zugriff 20.5.2007)
Laegemiddel Danish Medicines Agency (2006) Bioequivalence and labelling of medicinal products with regard to generic substitution. www.dkma.dk Zugriff 20.05.2007