Use of PBPK Modeling To Evaluate the Performance of DissolvIt, a Biorelevant Dissolution Assay for Orally Inhaled Drug Products-Reference-Cited by-同舟云学术

Use of PBPK Modeling To Evaluate the Performance of DissolvIt, a Biorelevant Dissolution Assay for Orally Inhaled Drug Products

Published:2019-01-14 Issue:3 Volume:16 Page:1245-1254
ISSN:1543-8384
Container-title:Molecular Pharmaceutics
language:en
Short-container-title:Mol. Pharmaceutics

Author:

Hassoun Mireille¹,Malmlöf Maria²³,Scheibelhofer Otto⁴,Kumar Abhinav¹,Bansal Sukhi¹,Selg Ewa²,Nowenwik Mattias²,Gerde Per²³,Radivojev Snezana⁴,Paudel Amrit⁴⁵^ORCID,Arora Sumit⁴,Forbes Ben¹^ORCID

Affiliation:

1. King’s College London, Institute of Pharmaceutical Science, London SE1 9NH, U.K.

2. Inhalation Sciences Sweden AB, Hälsovägen 7-9, 141 57 Huddinge, Sweden

3. Institute of Environmental Medicine, Karolinska Institutet, 171 77 Stockholm, Sweden

4. Research Centre Pharmaceutical Engineering GmbH, Inffeldgasse 13, Graz 8010, Austria

5. Institute of Process and Particle Engineering, Graz University of Technology, Inffeldgasse 13, Graz, 8010, Austria

Funder

Biotechnology and Biological Sciences Research Council

Publisher

American Chemical Society (ACS)

Subject

Drug Discovery,Pharmaceutical Science,Molecular Medicine

Link

http://pubs.acs.org/doi/pdf/10.1021/acs.molpharmaceut.8b01200

Reference45 articles.

1. US FDA CDER. Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070237.pdf.

2. In vitro–In Vivo Correlations: Tricks and Traps

3. Industry's View on Using Quality Control, Biorelevant, and Clinically Relevant Dissolution Tests for Pharmaceutical Development, Registration, and Commercialization

4. In Vivo Predictive Dissolution (IPD) and Biopharmaceutical Modeling and Simulation: Future Use of Modern Approaches and Methodologies in a Regulatory Context

5. In Vitro Aqueous Fluid-Capacity-Limited Dissolution Testing of Respirable Aerosol Drug Particles Generated from Inhaler Products

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