Concepedia

Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report

Sandra Suarez‐Sharp, Michael J. Cohen, Filippos Kesisoglou, Andreas Abend, Patrick Marroum, Poonam Delvadia, Evangelos Kotzagiorgis, Min Li, Anna Nordmark, Nagesh Bandi,

The AAPS Journal · 2018 · 77 citations · 8 references

DOI

Concepts

References

8

Physiologically based pharmacokinetic modeling in regulatory decision‐making at the European Medicines Agency

Elisa Luzon, Kevin Blake, Susan Cole et al. · Clinical Pharmacology & Therapeutics · 2016 · 131 citations

, , +10

Regulatory Experience with In Vivo In Vitro Correlations (IVIVC) in New Drug Applications

Sandra Suarez‐Sharp, Min Li, John Duan et al. · The AAPS Journal · 2016 · 100 citations

, , +11

Draft Guidance for Industry Extended-Release Solid Oral Dosage Forms

Henry Malinowski, Patrick Marroum, Venkata Ramana Uppoor et al. · Advances in experimental medicine and biology · 1997 · 88 citations

, , +12

FDA Guidance for Industry 1 Extended Release Solid Oral Dosage forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations

Henry Malinowski, Patrick Marroum, Venkata Ramana Uppoor et al. · Dissolution Technologies · 1997 · 88 citations · Full text

, , +12

Approaches for Establishing Clinically Relevant Dissolution Specifications for Immediate Release Solid Oral Dosage Forms

Andre Hermans, Andreas Abend, Filippos Kesisoglou et al. · The AAPS Journal · 2017 · 63 citations · Full text

, , +17