PCI 7 November 2023, 15:22
Thermofisher: Thu 29 February 2024, 11:15
BMG Labtech: Wed 18 September 2024, 11:55
Owen Mumford 12 January 2022, 16:46

Current Edition

Cell and Gene Therapy

Upcoming Events

NextGen BioMed – 04/02/2025
BioTrinity 2025 – January 30th 2025
Elrig R&I 2025 – 27th January 2025
Biotechnology Show 2025: 20th January 2025
Anglonordic: 16th January 2025
AI in Drug Discovery – SAE media – January 14th 2025

Advertisement

Fujifilm rectangle: Fri 22 November 2024, 14:23
Roald Dahl Charity: Fri 15 November 2024, 12:57
A&M STABTEST: Fri 21 June 2024, 11:43
CDD Vault: Wed 17 July 2024, 11:46
Aurisco – 04/02/2025

Exploring the 505(b)(2) Route for Systemic and Regional Therapy via Pulmonary Delivery

The Advantages of Using Respirable Engineered Spray-dried Dry Powder

Inhaled drug products offer several advantages over other dosage forms, including more targeted drug delivery, which can mean a lower dose is required, in turn reducing side-effects. Developing generic versions of complex products is increasingly challenging and it is important to consider a regulatory strategy to achieve market approval as quickly and efficiently as possible, using a simple and efficient pathway. In this article,  Aditya R. Das at Recipharm explores the use of the 505(b)(2) application route to advance inhalation drugs to market and the advantages of using respirable engineered spray-dried powder for the development of these products.

[wonderplugin_pdf src=”https://www.biopharmaceuticalmedia.com/wp-content/uploads/2018/12/Exploring-the-505b2-route-for.pdf” width=”100%” height=”900px” style=”border:0;”]

Newcells 3 June 2024, 15:12
Novonordisk: Wed 17 July 2024, 11:22
FujiFilm 30 October 2023, 16:23
Autoscribe Mon 26 June 2023, 15:15
Aldevron: 16th January 2025
Richter: Wed 23 October 2024, 09:03
GenXPro: Mon 16 September 2024, 10:40