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Reviews on Recent Clinical Trials

Editor-in-Chief

ISSN (Print): 1574-8871
ISSN (Online): 1876-1038

Letter to the Editor

Regulatory Procedures and Integrated Requirements for Early Phase Development of a Pharmaceutical Drug Product

Author(s): Gaurav, Niraj Sandeep Patil, Animesh Ranjan and Dilpreet Singh*

Volume 19, Issue 1, 2024

Published on: 25 October, 2023

Page: [2 - 3] Pages: 2

DOI: 10.2174/0115748871251739231018104151

Price: $65

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[2]
Scott D, Briggs NEB, Formosa A, et al. Impurity purging through systematic process development of a continuous two-stage crystallization. Org Process Res Dev 2023; 27(1): 148-58.
[http://dx.doi.org/10.1021/acs.oprd.2c00317]
[3]
Rawat T, Pandey IP. Forced degradation studies for drug substances and drug products-scientific and regulatory considerations. J Pharm Sci Res 2015; 7(5): 238-50.
[4]
Eskola SM, Leufkens HGM, Bate A, De Bruin ML, Gardarsdottir H. Use of real‐world data and evidence in drug development of medicinal products centrally authorized in Europe in 2018–2019. Clin Pharmacol Ther 2022; 111(1): 310-20.
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[5]
Gujarathi NA, Bakliwal AA, Rane BR, Pathan V, Keservani RK. Regulatory aspects of drug development for dermal products. Topical and Transdermal Drug Delivery Systems: Applications and Future Prospects 2023; 6: 287-303.
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Destro F, Barolo M. A review on the modernization of pharmaceutical development and manufacturing-trends, perspectives, and the role of mathematical modeling. Int J Pharm 2022; 620: 121715.
[http://dx.doi.org/10.1016/j.ijpharm.2022.121715] [PMID: 35367580]
[7]
Moeti L, Litedu M, Joubert J. The implementation of a risk-based assessment approach by the South African Health Products Regulatory Authority (SAHPRA). Pharmaceut Med 2023; 37(1): 71-91.
[http://dx.doi.org/10.1007/s40290-022-00452-w] [PMID: 36598646]
[8]
Troiano G, Nolan J, Parsons D, Van Geen Hoven C, Zale S. A quality by design approach to developing and manufacturing polymeric nanoparticle drug products. AAPS J 2016; 18(6): 1354-65.
[http://dx.doi.org/10.1208/s12248-016-9969-z] [PMID: 27631558]
[9]
Patravale VB, Disouza JI, Rustomjee M, Eds. Pharmaceutical product development: Insights into pharmaceutical processes, management and regulatory affairs. CRC Press 2016; Vol. 15: pp. 122-53.
[http://dx.doi.org/10.1201/b19579]

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