Guidance for industry : E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs.
| Corporate Authors: | Center for Drug Evaluation and Research (U.S.), Center for Biologics Evaluation and Research (U.S.), International Conference on Harmonisation |
|---|---|
| Format: | Government Document Conference Proceeding eBook |
| Language: | English |
| Published: |
Rockville, MD :
U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research,
[2005]
|
| Subjects: | |
| Online Access: | https://purl.fdlp.gov/GPO/LPS113902 |
Similar Items
Guidance for industry : E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs, questions and answers.
Published: (2008)
Published: (2008)
Guidance for industry : S7B nonclinical evaluation of the potential for delayed ventricular repolarization (QT Interval Prolongation) by human pharmaceuticals.
Published: (2005)
Published: (2005)
Dissertatio medica inauguralis de cordis palpitatione. : Quam, praeside Deo opt. max. ex authoritate magnifici rectoris, D. Lucae Schacht ... Nec non amplissimi senatûs academici consensu, & almae facultatis medicae decreto, pro gradu doctoratus, summisque in medicina honoribus & privilegiis ritè ac legitimè consequendis, eruditorum examini subjicit Eduardus Wetenhallus ... Ad diem 3 August. locô horisque solitis.
by: Wettenhall, Edward, 1636-1713
Published: (1684)
by: Wettenhall, Edward, 1636-1713
Published: (1684)
Guidance for industry : drug-induced liver injury, premarketing clinical evaluation.
Published: (2007)
Published: (2007)
Guidance for industry : Q1E evaluation of stability data.
Published: (2004)
Published: (2004)
Guidance for industry : CGMP for phase 1 investigational drugs.
Published: (2008)
Published: (2008)
Guidance for industry : stability testing, photostability testing of new veterinary drug substances and medicinal products.
Published: (1999)
Published: (1999)
Guidance for industry : nonclinical safety evaluation of drug or biologic combinations.
Published: (2006)
Published: (2006)
Antiarrhythmic drugs : mechanisms of antiarrhythmic and proarrhythmic actions /
Published: (1995)
Published: (1995)
Guidance for industry : drug-induced liver injury, premarketing clinical evaluation.
Published: (2009)
Published: (2009)
Guidance for industry : addendum to E2C clinical safety data management : periodic safety update reports for marketed drugs.
Published: (2004)
Published: (2004)
Guidance for industry : Q1A(R2) stability testing of new drug substances and products.
Published: (2003)
Published: (2003)
Guidance for industry : estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers.
Published: (2005)
Published: (2005)
Guidance for industry : Q1D bracketing and matrixing designs for stability testing of new drug substances and products.
Published: (2003)
Published: (2003)
Guidance for industry : E 11 clinical investigation of medicinal products in the pediatric population.
Published: (2000)
Published: (2000)
Guidance for industry : S6 preclinical safety evaluation of biotechnology-derived pharmaceuticals.
Published: (1997)
Published: (1997)
Guidance for industry : nonclinical safety evaluation of pediatric drug products.
Published: (2006)
Published: (2006)
Guidance for industry : S1B testing for carcinogenicity of pharmaceuticals.
Published: (1997)
Published: (1997)
Guidance for industry : S7A safety pharmacology studies for human pharmaceuticals.
Published: (2001)
Published: (2001)
Guidance for industry : Q1B photostability testing of new drug substances and products.
Published: (1996)
Published: (1996)
Guidance for industry : S8 immunotoxicity studies for human pharmaceuticals.
Published: (2006)
Published: (2006)
Guidance for industry and review staff : nonclinical safety evaluation of reformulated drug products and products intended for administration by an alternate route.
Published: (2008)
Published: (2008)
Guidance for industry : M3 nonclinical safety studies for the conduct of human clinical trials for pharmaceuticals.
Published: (1997)
Published: (1997)
Guidance for industry : photosafety testing.
Published: (2003)
Published: (2003)
Guidance for industry : stability testing of new veterinary dosage forms.
Published: (1999)
Published: (1999)
Guidance for industry : studies to evaluate the safety of residues of veterinary drugs in human food, carcinogenicity testing.
Published: (2006)
Published: (2006)
Guidance for industry : tropical disease priority review vouchers.
Published: (2008)
Published: (2008)
Guidance for industry : Q4B evaluation and recommendation of pharmocopoeial texts for use in the ICH regions : annex 3 test for particulate contamination, subdivisible particles general chapter.
Published: (2009)
Published: (2009)
Guidance for industry : investigating out-of-specification test results (OOS) for pharmaceutical production.
Published: (2006)
Published: (2006)
Guidance for industry : S1C(R2) dose selection for carcinogenicity studies.
Published: (2008)
Published: (2008)
Guidance for industry : S2B genotoxicity, a standard battery for genotoxicity testing of pharmaceuticals.
Published: (1997)
Published: (1997)
Guidance for industry : Q3C impurities, residual solvents.
Published: (1997)
Published: (1997)
Guidance for industry : statistical aspects of the design, analysis, and interpretation of chronic rodent carcinogenicity studies of pharmaceuticals.
Published: (2001)
Published: (2001)
Guidance for industry : analytical procedures and methods validation, chemistry, manufacturing, and controls documentation.
Published: (2000)
Published: (2000)
Guidance for industry : E2BM data elements for transmission of individual case safety reports.
Published: (2002)
Published: (2002)
Guidance for industry : process validation, general principles and practices.
Published: (2008)
Published: (2008)
Guidance for industry : stability testing of new biotechnological/biological veterinary medicinal products.
Published: (2001)
Published: (2001)
Guidance for industry : E2B(M), data elements for transmission of individual case study reports, questions and answers.
Published: (2005)
Published: (2005)
Guidance for industry : providing regulatory submissions to CBER in electronic format, investigational new drug applications (INDs).
Published: (2002)
Published: (2002)
Guidance for industry : submitting and reviewing complete responses to clinical holds.
Published: (2000)
Published: (2000)