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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. 

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  1. This study aimed on the one hand to clarify the quality, authenticity, safety, and other issues related to products of the anabolic-androgenic steroid methandienone advertised on the Internet and personally im...

    Authors: Robin Schreiber, Manami Hori, Chisato Takahashi, Mohammad Sofiqur Rahman, Ayane Nakao, Shu Zhu, Feiyu Zhu, Naoko Yoshida, Keiko Maekawa and Kazuko Kimura
    Citation: AAPS Open 2024 10:5
  2. This research study involves the development of an olanzapine (OLZ) formulation using various chemical penetration enhancers (CPEs) for transdermal delivery. The aim of this study was to obtain the initial dat...

    Authors: Amitkumar Virani, Nirali Dholaria, Hana Mohd, Nubul Albayati and Bozena Michniak-Kohn
    Citation: AAPS Open 2024 10:4
  3. Poor quality amoxicillin-clavulanate potassium tablets have been recently discovered in generic drugs related to Augmentin-like medicines containing amoxicillin and clavulanic acid, as well as its derivatives ...

    Authors: Eyob Endashaw, Ramanjireddy Tatiparthi, Tesfaye Mohammed, Henok Teshome, Markos Duguma and Yesuneh Tefera
    Citation: AAPS Open 2024 10:3
  4. The American Association of Pharmaceutical Scientists (AAPS) Chemistry, Manufacturing, and Control (CMC) Community hosted a virtual panel discussion on July 15, 2022, to provide a forum to discuss industry and...

    Authors: James Bernstein, Kim Huynh-Ba, Patrick Lynch, Thomas Oliver, Reza Oliyai, Scott W. Roberts, Andrea Schirmer, David Schwinke, Kin Tang and Jessica Ursin
    Citation: AAPS Open 2024 10:2
  5. Coprocessing involves integration of multiple substances to improve the physical, chemical, mechanical, and biopharmaceutical properties of a material. Coprocessing is a promising technique in the pharmaceutic...

    Authors: Kaushalendra Chaturvedi, Pasaorn Pongkulapa, Xiaoyi Ding, Harsh S. Shah, San Kiang and Veeran Kadajji
    Citation: AAPS Open 2023 9:19
  6. The October 2022 draft United States Food and Drug Administration (FDA) guidance presents an option of in vitro release test (IVRT) studies as a biowaiver for topical drug products submitted in abbreviated new...

    Authors: Hannah Wellington, Seeprarani Rath, Sagaran Abboo and Isadore Kanfer
    Citation: AAPS Open 2023 9:18
  7. Self-microemulsifying or self-nanoemulsifying drug delivery systems (SMEDDS/SNEDDS) are well known to improve the dissolution and increase the oral bioavailability of hydrophobic drugs, including herbal extrac...

    Authors: Dailenys Marrero-Morfa, César Ibarra-Alvarado, Francisco J. Luna-Vázquez, Miriam Estévez, Eremy Miranda Ledesma, Alejandra Rojas-Molina and Carlos T. Quirino-Barreda
    Citation: AAPS Open 2023 9:17
  8. Dihydroquercetin (DHQ) is a natural occurring dihydroflavonol that has strong antioxidant and antibacterial activities. However, its application is limited due to its poor solubility. This study aims to improv...

    Authors: Yaping Xu, Yue Wang, Chujie Li, Tao Han, Haiming Chen, Wenxue Chen, Qiuping Zhong, Jianfei Pei, Guido R. M. M. Haenen, Zhengwen Li, Mohamed Moalin, Ming Zhang and Weijun Chen
    Citation: AAPS Open 2023 9:16
  9. Patiromer powder for oral suspension (patiromer o.s.) is a once-daily, potassium (K+) binder approved for the treatment of hyperkalemia. It is known that patiromer o.s. can be mixed with water, apple juice, or cr...

    Authors: Martin Khoeiklang, Maria Wilhelm, Lingyun Li and Carol P. Moreno Quinn
    Citation: AAPS Open 2023 9:14
  10. Infectious and cancerous diseases are tedious to manage. The problem of drug resistance is often associated with anti-microbial and anti-cancer agents and is one of the most significant challenges that restric...

    Authors: Rana E. Elnady, Maha M. Amin and Mohamed Y. Zakaria
    Citation: AAPS Open 2023 9:13
  11. Arsenic trioxide (ATO) is a promising chemotherapeutic agent, but its clinical application is limited due to its poor pharmacokinetics and dose-limited toxicity. Moreover, the combination of ATO and sec-o-gluc...

    Authors: Jinlai Cheng, Kun Hong, Jianhui Sun, Hongmei Li, Yu Zhao, Qinghe Zhao, Yuqing Tan and Miyi Yang
    Citation: AAPS Open 2023 9:12
  12. Innovation in pharmaceutical therapeutics is critical for the treatment of serious diseases with unmet medical need. To accelerate the approval of these innovative treatments, regulatory agencies throughout th...

    Authors: Jill Beierle, Marquerita Algorri, Marisol Cortés, Nina S. Cauchon, Andrew Lennard, J. Paul Kirwan, Shirley Oghamian and Michael J. Abernathy
    Citation: AAPS Open 2023 9:11
  13. The low solubility, weak acid drug, niclosamide is a host cell modulator with broad-spectrum anti-viral cell-activity against many viruses, including stopping the SARS-CoV-2 virus from infecting cells in cell ...

    Authors: David Needham
    Citation: AAPS Open 2023 9:9
  14. Heat stress studies have been conducted in support of developing a heat-stable liquid solution of dalbavancin. The degradation products that form in heat-stressed buffered dalbavancin solutions have been ident...

    Authors: Sardar M. Jakaria, David E. Budil and James Murtagh
    Citation: AAPS Open 2023 9:8
  15. In this study, it was aimed to introduce a transdermal drug delivery system with dissolving microneedles (DMNs) based on gelatin (GEL) and sodium carboxymethyl cellulose (NaCMC) for lidocaine hydrochloride (Li...

    Authors: Shabnam Bahmani, Ramin Khajavi, Morteza Ehsani, Mohammad Karim Rahimi and Mohammad Reza Kalaee
    Citation: AAPS Open 2023 9:7
  16. Human absorption, distribution, metabolism, and excretion (hADME) studies of new drugs are required for global regulatory filings. Recent advances in high sensitivity analytical technologies have enabled micro...

    Authors: Sonika Sharma, Prashant Agarwal, Andrew T. Parsons, James E. Huckle and Tiffany L. Correll
    Citation: AAPS Open 2023 9:6
  17. The advent of recombinant protein-based therapeutic agents in the 1980s and subsequent waves of innovation in molecular biology and engineering of biologics has permitted the production of an increasingly broa...

    Authors: Roxanne K. Kunz, Atipat Rojnuckarin, Christian Marc Schmidt and Les P. Miranda
    Citation: AAPS Open 2023 9:5
  18. Vancomycin (VCM) is an antimicrobial that is recommended for therapeutic drug monitoring (TDM) for maintaining the efficacy and safety of treatment. The trough monitoring has been used to guide VCM dosing regi...

    Authors: Yuki Oshima, Mizuki Hori, Miyu Matsumoto and Masaru Kato
    Citation: AAPS Open 2023 9:2
  19. Random effects are often neglected when defining the control strategy for a biopharmaceutical process. In this article, we present a case study that highlights the importance of considering the variance introd...

    Authors: Thomas Oberleitner, Thomas Zahel, Marco Kunzelmann, Judith Thoma and Christoph Herwig
    Citation: AAPS Open 2023 9:4
  20. Lingzhu Pulvis are widely used in clinical practice because of their therapeutic effects, but their stability and efficacy are affected by the easy oxidation and volatility of Acorus calamus. In this study, we co...

    Authors: Lei Peng, Mei Wang, Xiao-Fei Zhang, Dong-Yan Guo, Bing-Tao Zhai, Jun-Bo Zou and Ya-Jun Shi
    Citation: AAPS Open 2023 9:1
  21. Glycopeptide antimicrobials are a class of naturally occurring or semi-synthetic glycosylated products that have shown antibacterial activity against gram-positive organisms by inhibiting cell-wall synthesis. ...

    Authors: Sardar M. Jakaria, David E. Budil and James Murtagh
    Citation: AAPS Open 2022 8:20
  22. The American Association of Pharmaceutical Scientists (AAPS) Chemistry, Manufacturing, and Controls (CMC) Community hosted two virtual panel discussions focusing on several novel regulatory review pathways for...

    Authors: Marquerita Algorri, Ajay Acharya, James Bernstein, Nina S. Cauchon, Xiao Hong Chen, Kim Huynh-Ba, Carol Krantz, Tao Li, Yiwei Li, Sherita McLamore, Scott W. Roberts, David Schwinke, Rakhi Shah, Andrea Schirmer, Helen Strickland, Kin Tang…
    Citation: AAPS Open 2022 8:19
  23. Nobiletin (NOB), a polymethoxyflavonoid, is known for its antioxidant and anti-inflammatory effects and has antitumor activity. However, its poor solubility and low bioavailability pose a significant challenge...

    Authors: Yutaka Inoue, Moe Ishizawa, Shoko Itakura, Takashi Tanikawa and Hiroaki Todo
    Citation: AAPS Open 2022 8:17
  24. Hydrolytic degradation of the polysorbate 20 (PS20) surfactant in protein-based liquid formulations releases free fatty acids (FFAs), which can accumulate to form particles in drug products during real-time (l...

    Authors: Inn H. Yuk, Theo Koulis, Nidhi Doshi, Kathrin Gregoritza, Constanze Hediger, Vanessa Lebouc-Haefliger, Jamie Giddings and Tarik A. Khan
    Citation: AAPS Open 2022 8:18
  25. This article describes in vitro and in vivo studies that aimed to further characterize the biopharmaceutical properties and pharmacokinetic (PK) profile of vericiguat and to guide dosing recommendations.

    Authors: Corina Becker, Michael Boettcher, Uwe Muenster, Stephanie Loewen, Maximilian Lobmeyer and Wolfgang Mueck
    Citation: AAPS Open 2022 8:16
  26. A holistic approach was taken to characterise lyophilisers at both laboratory and commercial scale to design a focused validation strategy for commercialising parenteral drug products. Vial heat transfer coeff...

    Authors: Sean Cullen, Emma Walsh, Valeria Gervasi, Dikshitkumar Khamar and Timothy R. McCoy
    Citation: AAPS Open 2022 8:14
  27. Research on cancer treatment is always of great importance because of the extensive and difficult treatment options and side effects of chemotherapeutic agents. Due to this, novel techniques for cancer treatme...

    Authors: Maria Alvi, Azka Yaqoob, Kanwal Rehman, Syed Muhammad Shoaib and Muhammad Sajid Hamid Akash
    Citation: AAPS Open 2022 8:12
  28. 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 Behnam, Shaun Brothers, Claes Wahlestedt, Claude-Henry Volmar, Daniel Bennett and Marshall Hayward
    Citation: AAPS Open 2022 8:11

    The Correction to this article has been published in AAPS Open 2022 8:13

  29. 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
  30. 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
  31. 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
  32. 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
  33. 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
  34. 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
  35. 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
  36. 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
  37. 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
  38. 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
  39. 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
  40. 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
  41. 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