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Drug Development Initiatives for Global Health

Edited by Paddy Shivanand and Mehran Yazdanian

Over the last few years, significant scientific advances have stimulated drug discovery in the infectious disease space, spurred by increased investment from several global stakeholders and collaborative drug discovery efforts between pharmaceutical industry and academia. We hope that this thematic series in AAPS Open will shed light on the challenges of drug discovery, development, and distribution to effectively address global drug development, with emphasis on technical, clinical, and regulatory challenges encountered in lower resource settings for both communicable and non communicable diseases. We hope to bring you perspectives from experts to highlight the impact of patient circumstances and regulatory environments on product development and eventually access to safe drug products in the context of global health. 

  1. Risk-Based Predictive Stability (RBPS) tools, such as the Accelerated Stability Assessment Program (ASAP) and other models, are used routinely within pharmaceutical development to quickly assess stability char...

    Authors: Megan McMahon, Helen Williams, Elke Debie, Mingkun Fu, Robert Bujalski, Fenghe Qiu, Yan Wu, Hanlin Li, Jin Wang, Cherokee Hoaglund-Hyzer and Donnie Pulliam

    Citation: AAPS Open 2020 6:1

    Content type: Review

    Published on:

  2. The comparison of quality attributes is a key element in the evaluation of both biosimilars and manufacturing process changes for biological medicines. Different statistical approaches are proposed to facilita...

    Authors: Thomas Stangler and Martin Schiestl

    Citation: AAPS Open 2019 5:4

    Content type: Research

    Published on:

  3. Substandard and falsified medicine screening technologies are invaluable tools for post-marketing surveillance of medicine quality, particularly in low- and middle-income countries. National Regulatory Authori...

    Authors: Lukas Roth, Kevin B. Biggs and Daniel K. Bempong

    Citation: AAPS Open 2019 5:2

    Content type: Review

    Published on: