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2007, Drugs and the pharmaceutical sciences, ISBN 9780849303951, Volume 171, 598
As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent... 
Drugs | Drug Approval | Models, Statistical | Therapeutic Equivalency | Other branches of medicine | Handbooks, manuals, etc | Therapeutic equivalency
eBook
Biopharmaceutics & drug disposition, ISSN 0142-2782
Journal
2007, 1. Aufl., Statistics in practice, ISBN 0470094753, xi, 311
Studies in bioequivalence are the commonly accepted method to demonstrate therapeutic equivalence between two medicinal products. Savings in time and cost are... 
Drugs | Clinical Trials | methods | Drug Design | Therapeutic Equivalency | Biostatistics | Medical | Therapeutic equivalency
Book
Zeitschrift fuer Evidenz, Fortbildung und Qualitaet im Gesundheitswesen, ISSN 1865-9217, 03/2019, Volume 140, pp. 58 - 62
The main advantage of an abbreviated licensing pathway is the possibility of extrapolating efficacy and safety data from an original medicinal product to a... 
Generika | Bioäquivalenz | extrapolation | comparability exercise | generics | biosimilars | Vergleichbarkeitsstudien | bioequivalence
Journal Article
2000, 2nd ed., rev. and expanded., Biostatistics, ISBN 0824775724, Volume 3, xii, 584
Book
2008, Drugs and the pharmaceutical sciences, ISBN 0849377846, Volume 180., x, 264
The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart.... 
Drugs | Generic drugs | Therapeutic equivalency | Bioavailability | Pharmaceutical Manufacturing | Pharmaceutical Science Regulatory | Drug Design & Development
Book
1992, Statistics, textbooks and monographs, ISBN 0824786823, Volume 133., x, 416
Book
Der Ophthalmologe, ISSN 0941-293X, 2/2015, Volume 112, Issue 2, pp. 127 - 139
Um die Vergleichbarkeit aller Latanoprost-Präparate bzw. deren Generika zu prüfen, wurde die Wirkstoffkonzentration der in Deutschland verfügbaren Präparate... 
Glaucoma | Bioäquivalenz | Packaging leaflet | Glaukom | Medicine & Public Health | Bioequivalence | Gebrauchsinformation | Benzalkoniumchlorid | Benzalkonium chloride | Ophthalmology | Ophthalmologika
Journal Article
INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS, ISSN 0946-1965, 02/1990, Volume 28, Issue 2, pp. 72 - 78
Journal Article
Wiener klinische Wochenschrift, ISSN 0043-5325, 2/2008, Volume 120, Issue 3, pp. 63 - 69
Since the introduction of generic drugs to the pharmaceutical market a sometimes emotional debate exists whether they are well-investigated and of high... 
Generika | Chemische Qualität | Bioequivalence | Pharmaceutical quality | Internal Medicine | Medicine/Public Health, general | Generic drugs | Bioäquivalenz | Pneumology/Respiratory System | Medicine & Public Health | Zulassung | Gastroenterology | Marketing authorisation | Interchangeability | Endocrinology | Austauschbarkeit
Journal Article
by Blume, H and Schug, B and Tautz, J and Erb, K
Bundesgesundheitsblatt Gesundheitsforsch.Gesundheitsschutz, ISSN 1436-9990, 5/2005, Volume 48, Issue 5, pp. 548 - 555
Im Rahmen der Entwicklung und Optimierung von Arzneimitteln spielen Bioverfügbarkeits- und Bioäquivalenzuntersuchungen eine wichtige Rolle. Unter der... 
Bioäquivalenz | CPMP Note for Guidance | Bioverfügbarkeit | Medicine & Public Health | CPMP-Leitlinie | Bioequivalence | General Practice / Family Medicine | Bioavailability | CPMP note for guidance
Journal Article
Medizinische Klinik, ISSN 0723-5003, 11/2004, Volume 99, Issue 11, pp. 639 - 644
Die Substitutionstherapie mit Levothyroxin (L-Thyroxin) ist die Therapie der Wahl bei Hypothyreosen verschiedener Ätiologie. Die therapeutische Äquivalenz von... 
T 4 substitution | Hypothyreose | Bioequivalence | TSH | T 4 -Tropfen | Bioavailability | Hypothyroidism | Medicine/Public Health, general | Levothyroxin | Bioäquivalenz | Levothyroxine | Bioverfügbarkeit | Medicine & Public Health | T 4 solution | T 4 -Substitutionstherapie | Thyrotropin | substitution | T | solution
Journal Article
INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS, ISSN 0946-1965, 1992, Volume 30, pp. S51 - S58
The statistical analysis of bioequivalence assessment has been consolidated in recent years through the work of Schuirmann [1987], Westlake [1988] and Hauschke... 
STATISTICS | SAMPLE SIZE | MULTIPLICATIVE MODEL | POWER | PHARMACOLOGY & PHARMACY | BIOEQUIVALENCE | SIDED TESTS PROCEDURE | STATISTICAL-ANALYSIS
Journal Article
Medizinische Klinik, ISSN 0723-5003, 7/1998, Volume 93, Issue 7, pp. 401 - 406
Der alimentäre Jodmangel ist eine, der Hauptursachen der endemischen Struma. Bei der Strumatherapie sollten der intrathyreoidale Jodgehalt erhöht und das TSH... 
Bioäquivalenz | Levothyroxine | Bioverfügbarkeit | Medicine & Public Health | Jodid TSH-Suppression | Bioequivalence | Internal Medicine | Iodide TSH-suppression | Bioavailability | Medicine/Public Health, general | Levothyroxin | Iodide | TSH-suppression
Journal Article
International journal of clinical pharmacology, therapy, and toxicology, ISSN 0174-4879, 1992, Volume 30 Suppl 1, p. S7
Based on general guidelines and requirements for the design and analysis of bioequivalence studies, specific recommendations are made for the presentation of... 
Theophylline - administration & dosage | Reproducibility of Results | Drug Administration Schedule | Humans | Delayed-Action Preparations | Research - standards | Writing - standards | Therapeutic Equivalency
Journal Article
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