ARTICLE;
BIOEQUIVALENCE;
CONTROLLED STUDY;
DRUG CAPSULE;
DRUG SOLUBILITY;
FOOD AND DRUG ADMINISTRATION;
INTERMETHOD COMPARISON;
PH;
STANDARD;
TABLET;
WORLD HEALTH ORGANIZATION;
CHEMISTRY;
COMPARATIVE STUDY;
DRUG APPROVAL;
INTESTINE SECRETION;
LEGAL ASPECT;
METABOLISM;
METHODOLOGY;
MICROCAPSULE;
PHARMACOKINETICS;
SOLUBILITY;
STOMACH JUICE;
UNITED STATES;
CAPSULES;
CHEMISTRY, PHARMACEUTICAL;
DOXYCYCLINE;
DRUG APPROVAL;
GASTRIC JUICE;
GELATIN;
HYDROGEN-ION CONCENTRATION;
INTESTINAL SECRETIONS;
SOLUBILITY;
TABLETS;
THERAPEUTIC EQUIVALENCY;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
WORLD HEALTH ORGANIZATION;
Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms
WHO, Geneva: World Health Organization
WHO. Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms. Annex 8 of WHO Expert Committee on Specifications for Pharmaceutical Preparations. Geneva: World Health Organization, 2006.
Washington DC: US Department of Health and Human Services
US FDA. Guidance for industry - waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. Washington DC: US Department of Health and Human Services, 2000.
A theoretical basis for a biopharmaceutic drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability
Amidon GL et al. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 1995; 12: 413-420.
Classification of orally administered drugs on the World Health Organization Model List of Essential Medicines according to the biopharmaceutics classification system
Lindenberg M et al. Classification of orally administered drugs on the World Health Organization Model List of Essential Medicines according to the biopharmaceutics classification system. Eur J Pharm Biopharm 2004; 58: 265-278.
Comparative bioavailability study of doxycycline hyclate (equivalent to 100 mg doxycycline) capsules (doxycin vs vibramycin) for bioequivalence evaluation in healthy adult volunteers
Alsarra IA et al. Comparative bioavailability study of doxycycline hyclate (equivalent to 100 mg doxycycline) capsules (doxycin vs vibramycin) for bioequivalence evaluation in healthy adult volunteers. Int J Clin Pharmacol Ther 42: 2004; 373-377.
