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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. Resveratrol exhibits a wide range of biological properties, including anti-glycation, antioxidant, anti-inflammation, neuroprotective (including against advanced dementia and Alzheimer’s disease), anti-cancer,...

    Authors: Christopher Kemper, Dariush Benham, Shaun Brothers, Claes Wahlestedt, Claude-Henry Volmar, Daniel Bennett and Marshall Hayward
    Citation: AAPS Open 2022 8:11
  2. There is considerable pressure in the pharmaceutical industry to advance better molecules faster. One pervasive concern for protein-based therapeutics is the presence of potential chemical liabilities. We have...

    Authors: Alex W. Jacobitz, Wilfredo Rodezno and Neeraj J. Agrawal
    Citation: AAPS Open 2022 8:10
  3. To study structure-specific solubilization effect of Sulfobutyl ether-β-cyclodextrin (SBE-β-CD) on Remdesivir (RDV) and to understand the experimental clathration with the aid of quantum mechanics (QM), molecu...

    Authors: Yumeng Zhang, Zhouming Zhao, Kai Wang, Kangjie Lyu, Cai Yao, Lin Li, Xia Shen, Tengfei Liu, Xiaodi Guo, Haiyan Li, Wenshou Wang and Tsai-Ta Lai
    Citation: AAPS Open 2022 8:9
  4. The aim of this study was to investigate powder mechanics upon compression using data obtained from force-displacement (F-D) curves. The Kawakita model of powder compression analysis was adopted in order to co...

    Authors: Iyad Rashid, Rula Raji Haddadin, Ashaar Abdulsalam Alkafaween, Rawan Nayef Alkaraki and Rehan Mohammad Alkasasbeh
    Citation: AAPS Open 2022 8:6
  5. Poloxamer 188 (P188) as a non-ionic surfactant is used in proteinaceous formulations to prevent protein adsorption to hydrophobic surfaces and unfolding at interfaces, preventing the formation of aggregates an...

    Authors: Wei Chen, Siegfried Stolz, Vincent Wegbecher, Dixy Parakkattel, Christina Haeuser, Nuria Sancho Oltra, Ravuri S. K. Kishore, Steven Bond, Christian Bell and Robert Kopf
    Citation: AAPS Open 2022 8:5
  6. This study explores the impact of antibody surface charge on tissue distribution into various tissues including tumor. Tumor-bearing mice were dosed intravenously with a mixture comprising three antibodies eng...

    Authors: Jakob C. Stüber, Karin F. Rechberger, Saša M. Miladinović, Thomas Pöschinger, Tamara Zimmermann, Remi Villenave, Miro J. Eigenmann, Thomas E. Kraft, Dhaval K. Shah, Hubert Kettenberger and Wolfgang F. Richter
    Citation: AAPS Open 2022 8:3
  7. This conference report summarized a full-day workshop, “best practices for the development and fit-for-purpose validation of biomarker methods,” which was held prior to the American Association of Pharmaceutic...

    Authors: Joel Mathews, Lakshmi Amaravadi, Steven Eck, Lauren Stevenson, Yow-Ming C. Wang, Viswanath Devanarayan, John Allinson, Kelly Lundsten, Michele Gunsior, Yan G. Ni, Marc-Olivier Pepin, Audrey Gagnon, Curtis Sheldon, Paul C. Trampont and Virginia Litwin
    Citation: AAPS Open 2022 8:2
  8. The COVID-19 pandemic has led to increased usage of hand sanitizer products by the public to prevent the spread of COVID-19 and decrease the likelihood of acquiring the disease. The increase in demand has also...

    Authors: Nicolas Abrigo, Connie Ruzicka, Patrick Faustino, Neil Stiber, Agnes NguyenPho, Thomas O’Connor and Diaa Shakleya
    Citation: AAPS Open 2022 8:1
  9. The oil-in-water (O/W) nano-emulsion (NE) is expanded to enhance the bioavailability of hydrophobic compounds. The NE can be prepared by herbal extract and essential oil as herbal medicines for antidiabetic tr...

    Authors: Sara Javadi, Negar Motakef Kazemi and Raheleh Halabian
    Citation: AAPS Open 2021 7:13
  10. The use of a Quality by Design (QbD) approach in the development of pharmaceutical products is known to bring many advantages to the table, such as increased product and process knowledge, robust manufacturing...

    Authors: Madalena Testas, Tiago da Cunha Sais, Leonardo Piccoli Medinilha, Katia Nami Ito Niwa, Lucas Sponton de Carvalho, Silvia Duarte Maia, Anderson Flores, Lígia Pedroso Braz, José Cardoso Menezes and Cássio Yooiti Yamakawa
    Citation: AAPS Open 2021 7:12
  11. Dostarlimab (JEMPERLI) is a humanized anti-programmed death 1 (PD-1) immunoglobulin (Ig)G4-kappa monoclonal antibody that binds to the PD-1 receptor and competitively inhibits binding of its ligands, PD-L1 and...

    Authors: Marilyn Patterson, Lee Anne Beausang, Bonita Rup, Ronald R. Bowsher, Kim Krug, Murad Melhem and Sharon Lu
    Citation: AAPS Open 2021 7:11
  12. Skin cancer is fifth most diagnosed disease in human population due to ultraviolet radiation (UV) exposure. Gamma oryzanol (OZ) is a natural antioxidant, and it also has skin anti-aging properties. OZ is natur...

    Authors: Harsh S. Shah, Ankit Gotecha, Dolly Jetha, Amarjitsing Rajput, Aditi Bariya, Shital Panchal and Shital Butani
    Citation: AAPS Open 2021 7:9
  13. The Stability Community of the American Association of Pharmaceutical Scientists (AAPS) held a virtual workshop on “Vaccine Stability Considerations to Enable Rapid Development and Deployment”, on March 24-25,...

    Authors: Mark Alasandro, Dilip Choudhury, Kim Huynh-Ba, Jianmei Kochling, Christopher Latoz, Laure Larkin, Lori McCaig, Nanda Subbarao, Yan Wu and Yajie Zhang
    Citation: AAPS Open 2021 7:6
  14. This study aimed to achieve an in vitro quantification of the effects of composition and formulation factors on the killing rates of alcohol-based hand sanitizers. The killing rates of 85% ethyl alcohol (ET) a...

    Authors: Ifeanyi T. Nzekwe, Onyedika I. Agwuka, Moses U. Okezie, Daniel O. Fasheun, Petra O. Nnamani and Chukwuma O. Agubata
    Citation: AAPS Open 2021 7:5
  15. A novel approach to tritium-labeled antisense oligonucleotides (ASO) was established by conjugating N-succinimidyl propionate, as well as maleimide-derivatives, to the 3′-end of ASOs targeting metastasis-associat...

    Authors: Martin R. Edelmann, Christophe Husser, Martina B. Duschmalé, Guy Fischer, Claudia Senn, Erich Koller and Andreas Brink
    Citation: AAPS Open 2021 7:4
  16. Dostarlimab is a humanized anti–PD-1 monoclonal antibody. Dostarlimab (JEMPERLI; TSR-042) was recently approved in the USA and in the EU. The presence of neutralizing antibodies (NAbs) is a cause for concern b...

    Authors: Xiaolong Tom Zhang, Hong Chen, Weiping Shao, Zhongping John Lin, Murad Melhem and Sharon Lu
    Citation: AAPS Open 2021 7:8
  17. Design of experiments (DOE)-based analytical quality by design (AQbD) method evaluation, development, and validation is gaining momentum and has the potential to create robust chromatographic methods through d...

    Authors: Yongzhi Dong, Zhimin Liu, Charles Li, Emily Pinter, Alan Potts, Tanya Tadey and William Weiser
    Citation: AAPS Open 2021 7:3
  18. We previously developed a triazole modified tetraiodothyroacetic acid (TAT) conjugated to a polyethylene glycol (PEG)-based thyrointegrin αvβ3 antagonist targeted compound, called P-bi-TAT. It exhibited potent...

    Authors: Kazutoshi Fujioka, Kavitha Godugu and Shaker A. Mousa
    Citation: AAPS Open 2021 7:2
  19. 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
  20. 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
  21. 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