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Biometrical Journal, ISSN 0323-3847, 11/2017, Volume 59, Issue 6, pp. 1402 - 1403
Journal Article
Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz, ISSN 1436-9990, 6/2019, Volume 62, Issue 6, pp. 706 - 712
Die Rolle von Ethikkommissionen bei der Bewertung klinischer Arzneimittelprüfungen hat sich im Laufe der Jahre gewandelt. Aus den kollegialen Beratungsgremien... 
Klinische Arzneimittelprüfungen | Public Health | Medicine & Public Health | Ethikkommissionen | Klinische Studien | Clinical trials with medicinal products | General Practice / Family Medicine | Arzneimittelgesetz (AMG) | German Medicinal Products Act (AMG) | Clinical studies | Ethics committees
Journal Article
Pharmaceutical Statistics, ISSN 1539-1604, 09/2019, Volume 18, Issue 5, pp. 600 - 626
With advancement of technologies such as genomic sequencing, predictive biomarkers have become a useful tool for the development of personalized medicine.... 
predictive biomarker | treatment‐by‐subgroup interactions | decision trees | personalized medicine | SURVIVAL | CONFIRMATORY ADAPTIVE DESIGNS | treatment-by-subgroup interactions | THERAPY | VALIDATION | PHARMACOLOGY & PHARMACY | STATISTICS & PROBABILITY | KRAS | SELECTION | Index Medicus | Main Papers | Main Paper
Journal Article
Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz, ISSN 1436-9990, 06/2019, Volume 62, Issue 6, p. 706
Die Rolle von Ethikkommissionen bei der Bewertung klinischer Arzneimittelprufungen hat sich im Laufe der Jahre gewandelt. Aus den kollegialen Beratungsgremien... 
Medical research | Ethics | Clinical trials | Medicine, Experimental | Medical ethics
Journal Article
Journal of Biopharmaceutical Statistics, ISSN 1054-3406, 01/2018, Volume 28, Issue 1, pp. 3 - 9
Recently, new draft guidelines on multiplicity issues in clinical trials have been issued by European Medicine Agency (EMA) and Food and Drug Administration... 
Clinical trials | drug approval | multiplicity | CLINICAL-TRIALS | HOLM | PHARMACOLOGY & PHARMACY | STATISTICS & PROBABILITY | CLOSED TESTS | BONFERRONI
Journal Article
Journal of the Royal Statistical Society. Series B (Statistical Methodology), ISSN 1369-7412, 1/2014, Volume 76, Issue 1, pp. 265 - 295
Dose finding studies often compare several doses of a new compound with a marketed standard treatment as an active control. In the past, however, research has... 
Dose estimation | Dose response | Active control | Bayesian optimal designs | Minimax design | MAXIMIN | STATISTICS & PROBABILITY | EQUIVALENCE | INTERPOLATION | EXTRAPOLATION | MODELS | NONPARAMETRIC-ESTIMATION | EMAX | Studies | Statistical analysis | Regression analysis | Drug dosages | Pharmaceutical sciences
Journal Article
Circulation, ISSN 0009-7322, 03/2001, Volume 103, Issue 12, pp. 1662 - 1668
Journal Article
The Journal of Physical Chemistry B, ISSN 1520-6106, 04/2009, Volume 113, Issue 15, pp. 5273 - 5281
The dependence of the effective chemical shielding anisotropy (effective CSA, Δσeff) on the φ and ψ peptide backbone torsion angles was calculated in the... 
B: Biophysical Chemistry | RESIDUAL DIPOLAR COUPLINGS | SHIFT ANISOTROPY | DIHEDRAL ANGLE PSI | CORRELATION-ENERGY | CHEMISTRY, PHYSICAL | GLYCOSIDIC BOND | SOLUTION NMR-SPECTROSCOPY | SUGAR PUCKER | RNA OLIGONUCLEOTIDES | NUCLEIC-ACIDS | HYDROGEN-BONDS | Models, Chemical | Dipeptides - chemistry | Anisotropy | Computer Simulation | Usage | Alanine | Research | Peptides | Properties
Journal Article
Orphanet Journal of Rare Diseases, ISSN 1750-1172, 10/2018, Volume 13, Issue 1, pp. 186 - 9
Journal Article
Pharmaceutical Statistics, ISSN 1539-1604, 01/2017, Volume 16, Issue 1, pp. 12 - 19
Randomized controlled trials (RCTs) aim at providing reliable estimates of treatment benefit. Missing data and nonadherence to treatment are distinct problems... 
selection bias | nonadherence | clinical trials | ICH E9 | missing data | causality | SENSITIVITY | PHARMACOLOGY & PHARMACY | STATISTICS & PROBABILITY | INFERENCE | Data Interpretation, Statistical | Randomized Controlled Trials as Topic - methods | Humans | Endpoint Determination | Intention to Treat Analysis | Selection Bias | Patient Compliance | Research Design
Journal Article
Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz, 04/2019
Over the years, the role of ethics committees (ECs) in the review process of clinical trial applications (CTAs) has changed from being a collegial advisory... 
Journal Article
Archives of Toxicology, ISSN 0340-5761, 10/2017, Volume 91, Issue 10, pp. 3427 - 3438
Journal Article
Therapeutic Innovation & Regulatory Science, ISSN 2168-4790, 7/2015, Volume 49, Issue 4, pp. 584 - 592
Lack of adherence to study protocol and missing data are often unavoidable in clinical trials, and both increase the need to differentiate between the ideal... 
effectiveness | nonadherence | estimands | clinical trials | efficacy | missing data | ASSUMPTIONS | MEDICAL INFORMATICS | SENSITIVITY | PREVENTION | FRAMEWORK | PHARMACOLOGY & PHARMACY | Objectives | Clinical trials | Validity | Clinical medicine | Authorship
Journal Article
Pharmaceutical Statistics, ISSN 1539-1604, 03/2019, Volume 18, Issue 2, pp. 166 - 183
The analysis of adverse events (AEs) is a key component in the assessment of a drug's safety profile. Inappropriate analysis methods may result in misleading... 
estimands | safety data | clinical trials | adverse events | benefit assessment | STATISTICAL-METHODS | TRIALS | COST-EFFECTIVENESS | METAANALYSIS | STATE | STATISTICS & PROBABILITY | COMPETING RISKS | MODEL | ISSUES | PHARMACOLOGY & PHARMACY | Main Papers | Main Paper
Journal Article