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Pharmaceutical Development and Technology Volume 23, 2018 - Issue 10: Issue Theme: Drug stability testing and formulation strategies
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Review Article

The road to market implantable drug delivery systems: a review on US FDA’s regulatory framework and quality control requirements

Sana Al-JawadiSchool of Pharmacy, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand
,
Pier CapassoSchool of Pharmacy, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand
&
Manisha SharmaSchool of Pharmacy, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New ZealandCorrespondence[email protected]
Pages 953-963 | Received 10 Apr 2018, Accepted 04 Aug 2018, Published online: 10 Oct 2018

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Read on this site (2)

Tarek Metwally Ibrahim, Nagia Ahmed El-Megrab & Hanan Mohammed El-Nahas. (2021) An overview of PLGA in-situ forming implants based on solvent exchange technique: effect of formulation components and characterization. Pharmaceutical Development and Technology 26:7, pages 709-728.
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Zahra Mohtashami, Zahra Esmaili, Molood Alsadat Vakilinezhad, Ehsan Seyedjafari & Hamid Akbari Javar. (2020) Pharmaceutical implants: classification, limitations and therapeutic applications. Pharmaceutical Development and Technology 25:1, pages 116-132.
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Articles from other publishers (6)

Mohammad Mohtasim Hamid Pial, Asahi Tomitaka, Nezih Pala & Upal Roy. (2022) Implantable Devices for the Treatment of Breast Cancer. Journal of Nanotheranostics 3:1, pages 19-38.
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Wei Li, Jie Tang, Dennis Lee, Thomas R. Tice, Steven P. Schwendeman & Mark R. Prausnitz. (2022) Clinical translation of long-acting drug delivery formulations. Nature Reviews Materials 7:5, pages 406-420.
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Alexey Fayzullin, Alesia Bakulina, Karen Mikaelyan, Anatoly Shekhter & Anna Guller. (2021) Implantable Drug Delivery Systems and Foreign Body Reaction: Traversing the Current Clinical Landscape. Bioengineering 8:12, pages 205.
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Alexey Fayzullin, Semyon Churbanov, Natalia Ignatieva, Olga Zakharkina, Mark Tokarev, Daniil Mudryak, Yana Khristidis, Maxim Balyasin, Alexandr Kurkov, Elena N. Golubeva, Nadejda A. Aksenova, Tatyana Dyuzheva, Peter Timashev, Anna Guller & Anatoly Shekhter. (2021) Local Delivery of Pirfenidone by PLA Implants Modifies Foreign Body Reaction and Prevents Fibrosis. Biomedicines 9:8, pages 853.
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Hèctor López‐Laguna, Eloi Parladé, Patricia Álamo, Julieta M. Sánchez, Eric Voltà‐Durán, Naroa Serna, Laura Sánchez‐García, Olivia Cano‐Garrido, Alejandro Sánchez‐Chardi, Antonio Villaverde, Ramón Mangues, Ugutz Unzueta & Esther Vázquez. (2021) In Vitro Fabrication of Microscale Secretory Granules. Advanced Functional Materials 31:21, pages 2100914.
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Teodora Miclăuş, Vasiliki Valla, Angeliki Koukoura, Anne Ahlmann Nielsen, Benedicte Dahlerup, Georgios-Ioannis Tsianos & Efstathios Vassiliadis. (2019) Impact of Design on Medical Device Safety. Therapeutic Innovation & Regulatory Science 54:4, pages 839-849.
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