Mechanistic modeling of drug products applied to the skin: A workshop summary report-Reference-Cited by-同舟云学术

Mechanistic modeling of drug products applied to the skin: A workshop summary report

Published:2022-12 Issue: Volume: Page:
ISSN:2163-8306
Container-title:CPT: Pharmacometrics & Systems Pharmacology
language:en
Short-container-title:CPT Pharmacom & Syst Pharma

Author:

Tsakalozou Eleftheria¹,Alam Khondoker¹,Ghosh Priyanka²,Spires Jessica³,Polak Sebastian⁴⁵,Fang Lanyan¹,Sammeta Srinivasa⁶,Zhao Ping⁷,Arora Sumit⁴⁸,Raney Sam G.²^ORCID

Affiliation:

1. Division of Quantitative Methods and Modeling Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA) Silver Spring Maryland USA

2. Division of Therapeutic Performance I Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA) Silver Spring Maryland USA

3. Simulations Plus, Inc. Lancaster California USA

4. Certara UK, Simcyp Division Sheffield UK

5. Jagiellonian University Medical College Krakow Poland

6. Teva Pharmaceuticals Salt Lake City Utah USA

7. Bill & Melinda Gates Foundation Seattle Washington USA

8. Janssen Pharmaceutical, Companies of Johnson & Johnson Beerse Belgium

Publisher

Wiley

Subject

Pharmacology (medical),Modeling and Simulation

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/psp4.12893

Reference30 articles.

1. Transdermal patches: history, development and pharmacology

2. Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products

3. Generic Drug User Fee Amendments GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018‐2022 Commitment Letter.https://www.fda.gov/media/101052/download. Accessed May 8 2022

4. Innovation for Generic Drugs: Science and Research Under the Generic Drug User Fee Amendments of 2012

5. A new paradigm for topical generic drug products: Impact on therapeutic access

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