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Biowaiver for Immediate and Modified Release Dosage forms Scientific summary of the CSPS workshop.
- Published in:
- 2020
- By:
- Publication type:
- journal article
BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements.
- Published in:
- AAPS Journal, 2016, v. 18, n. 3, p. 612, doi. 10.1208/s12248-016-9877-2
- By:
- Publication type:
- Article
Survey of International Regulatory Bioequivalence Recommendations for Approval of Generic Topical Dermatological Drug Products.
- Published in:
- AAPS Journal, 2015, v. 17, n. 1, p. 121, doi. 10.1208/s12248-014-9679-3
- By:
- Publication type:
- Article
Analysis of Imprecision in Incurred Sample Reanalysis for Small Molecules.
- Published in:
- AAPS Journal, 2015, v. 17, n. 1, p. 206, doi. 10.1208/s12248-014-9689-1
- By:
- Publication type:
- Article
Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products.
- Published in:
- Pharmaceutical Research, 2014, v. 31, n. 4, p. 837, doi. 10.1007/s11095-013-1259-1
- By:
- Publication type:
- Article
Bioequivalence study designs for generic solid oral anticancer drug products: Scientific and regulatory considerations.
- Published in:
- Journal of Clinical Pharmacology, 2013, v. 53, n. 12, p. 1252, doi. 10.1002/jcph.163
- By:
- Publication type:
- Article
International Guidelines for Bioequivalence of Systemically Available Orally Administered Generic Drug Products: A Survey of Similarities and Differences.
- Published in:
- AAPS Journal, 2013, v. 15, n. 4, p. 974, doi. 10.1208/s12248-013-9499-x
- By:
- 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
- By:
- Publication type:
- Article
Use of In Vitro-In Vivo Correlation to Predict the Pharmacokinetics of Several Products Containing a BCS Class 1 Drug in Extended Release Matrices.
- Published in:
- Pharmaceutical Research, 2013, v. 30, n. 1, p. 179, doi. 10.1007/s11095-012-0861-y
- By:
- 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
- By:
- 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
- By:
- 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
- By:
- Publication type:
- Article
Summary Workshop Report: Facilitating Oral Product Development and Reducing Regulatory Burden Through Novel Approaches to Assess Bioavailability/Bioequivalence.
- Published in:
- 2012
- By:
- Publication type:
- Report
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
- By:
- Publication type:
- Article
Dissolution Testing for Generic Drugs: An FDA Perspective.
- Published in:
- AAPS Journal, 2011, v. 13, n. 3, p. 328, doi. 10.1208/s12248-011-9272-y
- By:
- Publication type:
- Article
Using Partial Area for Evaluation of Bioavailability and Bioequivalence.
- Published in:
- Pharmaceutical Research, 2011, v. 28, n. 8, p. 1939, doi. 10.1007/s11095-011-0421-x
- By:
- Publication type:
- Article
Utility of Physiologically Based Absorption Modeling in Implementing Quality by Design in Drug Development.
- Published in:
- AAPS Journal, 2011, v. 13, n. 1, p. 59, doi. 10.1208/s12248-010-9250-9
- By:
- Publication type:
- Article
Challenges and Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products: Workshop Summary Report.
- Published in:
- 2010
- By:
- Publication type:
- Report
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
- By:
- Publication type:
- Article
Evaluation of a Scaling Approach for the Bioequivalence of Highly Variable Drugs.
- Published in:
- AAPS Journal, 2008, v. 10, n. 3, p. 450, doi. 10.1208/s12248-008-9053-4
- By:
- Publication type:
- Article
Evaluation of a Scaling Approach for the Bioequivalence of Highly Variable Drugs.
- Published in:
- 2008
- By:
- Publication type:
- Correction notice
Bioequivalence Approaches for Highly Variable Drugs and Drug Products.
- Published in:
- Pharmaceutical Research, 2008, v. 25, n. 1, p. 237, doi. 10.1007/s11095-007-9434-x
- By:
- Publication type:
- Article
Highly Variable Drugs: Observations from Bioequivalence Data Submitted to the FDA for New Generic Drug Applications.
- Published in:
- AAPS Journal, 2008, v. 10, n. 1, p. 148, doi. 10.1208/s12248-008-9015-x
- By:
- Publication type:
- Article
FDA Evaluations Using In Vitro Metabolism to Predict and Interpret In Vivo Metabolic Drug-Drug Interactions: Impact on Labeling.
- Published in:
- Journal of Clinical Pharmacology, 1999, v. 39, n. 9, p. 899, doi. 10.1177/009127009903900902
- By:
- Publication type:
- Article