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Scientific Considerations for the Review and Approval of First Generic Mometasone Furoate Nasal Suspension Spray in the United States from the Bioequivalence Perspective.
- Published in:
- AAPS Journal, 2019, v. 21, n. 2, p. 1, doi. 10.1208/s12248-018-0283-9
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- Publication type:
- Article
Bioequivalence study designs for generic solid oral anticancer drug products: Scientific and regulatory considerations.
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- Journal of Clinical Pharmacology, 2013, v. 53, n. 12, p. 1252, doi. 10.1002/jcph.163
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- Publication type:
- Article
Common Reasons for "For-Cause" Inspections in Bioequivalence Studies Submitted to the Food and Drug Administration.
- Published in:
- AAPS Journal, 2013, v. 15, n. 1, p. 10, doi. 10.1208/s12248-012-9415-9
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- Publication type:
- Article
Statistics on BCS Classification of Generic Drug Products Approved Between 2000 and 2011 in the USA.
- Published in:
- AAPS Journal, 2012, v. 14, n. 4, p. 664, doi. 10.1208/s12248-012-9384-z
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- Publication type:
- Article
Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration.
- Published in:
- AAPS Journal, 2012, v. 14, n. 4, p. 915, doi. 10.1208/s12248-012-9406-x
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- Publication type:
- Article
Use of Partial Area under the Curve Metrics to Assess Bioequivalence of Methylphenidate Multiphasic Modified Release Formulations.
- Published in:
- AAPS Journal, 2012, v. 14, n. 4, p. 925, doi. 10.1208/s12248-012-9397-7
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- Publication type:
- Article
Common Deficiencies with Bioequivalence Submissions in Abbreviated New Drug Applications Assessed by FDA.
- Published in:
- AAPS Journal, 2012, v. 14, n. 1, p. 19, doi. 10.1208/s12248-011-9312-7
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- Publication type:
- Article
Generic drugs – safe, effective, and affordable.
- Published in:
- Dermatologic Therapy, 2009, v. 22, n. 3, p. 229, doi. 10.1111/j.1529-8019.2009.01236.x
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- Publication type:
- Article
First measured plasma concentration value as C<sub>max</sub>; impact on the C<sub>max</sub> confidence interval in bioequivalence studies†.
- Published in:
- Biopharmaceutics & Drug Disposition, 2000, v. 21, n. 4, p. 139, doi. 10.1002/1099-081X(200005)21:4<139::AID-BDD223>3.0.CO;2-H
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- Publication type:
- Article
Use of Reflectance Spectrophotometry in the Human Corticosteroid Skin Blanching Assay.
- Published in:
- 1993
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- Publication type:
- Other
The effect of fluconazole on the steady-state pharmacokinetics and electrocardiographic pharmacodynamics of terfenadine in humans.
- Published in:
- Clinical Pharmacology & Therapeutics, 1993, v. 53, n. 6, p. 630, doi. 10.1038/clpt.1993.83
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- Publication type:
- Article
Changes in the pharmacokinetics and electrocardiographic pharmacodynamics of terfenadine with concomitant administration of erythromycin.
- Published in:
- Clinical Pharmacology & Therapeutics, 1992, v. 52, n. 3, p. 231, doi. 10.1038/clpt.1992.135
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- Publication type:
- Article
Enantiomeric analysis of terfenadine in rat plasma by HPLC.
- Published in:
- Chirality, 1991, v. 3, n. 6, p. 467, doi. 10.1002/chir.530030610
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- Publication type:
- Article
Transcutaneous Chemical Collection of Caffeine in Normal Subjects: Relationship to Area Under the Plasma Concentration-Time Curve and Sweat Production.
- Published in:
- Journal of Investigative Dermatology, 1991, v. 96, n. 2, p. 186, doi. 10.1111/1523-1747.ep12461011
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- Publication type:
- Article
Transcutaneous theophylline collection in preterm infants.
- Published in:
- Clinical Pharmacology & Therapeutics, 1990, v. 47, n. 4, p. 427, doi. 10.1038/clpt.1990.53
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- Publication type:
- Article
Hemodynamic Effects During Rest and Exercise of Bucindolol in Hypertensive Men.
- Published in:
- 1987
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- Publication type:
- Other
False-positive digoxin measurements due to conjugated metabolite accumulation in combined renal and hepatic dysfunction.
- Published in:
- 1987
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- Publication type:
- journal article