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  1. 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
    Content type: Research Published on:

  2. 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
    Content type: Perspective Published on:

  3. 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
    Content type: Research Published on:

  4. 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
    Content type: Research Published on:

  6. 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
    Content type: Research Published on:

  7. 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
    Content type: Review Published on:

  8. 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
    Content type: Meeting report Published on:

  9. 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
    Content type: Research Published on:

  10. 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
    Content type: Research Published on:

  11. 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
    Content type: Research Published on:

  13. 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
    Content type: Research Published on:

  14. 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
    Content type: Perspective Published on:

  16. 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
    Content type: Research Published on:

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

  17. 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
    Content type: Perspective Published on:

  18. 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
    Content type: Research Published on:

  21. 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
    Content type: Research Published on:

  22. 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
    Content type: Research Published on:

  24. 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
    Content type: Research Published on:

  25. 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
    Content type: Meeting report Published on:

  26. 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
    Content type: Research Published on:

  27. 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
    Content type: Research Published on:

  28. 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
    Content type: Research Published on:

  29. 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
    Content type: Research Published on:

  31. 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
    Content type: Research Published on:

  32. 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
    Content type: Meeting report Published on:

  33. 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
    Content type: Research Published on:

  35. 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
    Content type: Research Published on:

  36. 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
    Content type: Research Published on:

  37. 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
    Content type: Research Published on:

  38. 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
    Content type: Research Published on:

  40. 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:

  41. 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:

  43. 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:

  44. Potassium chloride (KCl) syrup is widely used for the oral treatment of the hypokalemia. However, it is associated with unacceptable taste. In the present study, we sought to develop a palatable and easy to re...

    Authors: Madhur Kulkarni, Brijesh Vishwakarma, Samik Sen, Sandhya Anupuram and Abhijit A. Date
    Citation: AAPS Open 2019 5:1
    Content type: Research Published on:

  47. Auto-injection devices must be easy and intuitive to use, especially in emergency situations. However, there are many reports of safety-related issues affecting auto-injectors and pen injectors, due to usabili...

    Authors: Thomas Weinhold, Marzia Del Zotto, Jessica Rochat, Jessica Schiro, Sylvia Pelayo and Romaric Marcilly
    Citation: AAPS Open 2018 4:7
    Content type: Review Published on:

  48. Therapies based on monoclonal antibodies (mAbs) have delivered an impressive success in the clinics due to their exquisite specificity, potential for agonistic or antagonistic responses, tunable effector funct...

    Authors: Maribel Beaumont, Daniela Tomazela, Douglas Hodges, Grigori Ermakov, Edward Hsieh, Isabel Figueroa, On-Yee So, Yaoli Song, Huiping Ma, Svetlana Antonenko, Wondwessen Mengesha, Yi Wei Zhang, Shuli Zhang, SuChun Hseih, Gulesi Ayanoglu, Xiaoyan Du…
    Citation: AAPS Open 2018 4:6
    Content type: Research Published on:

  49. Highly selective drug targeting is an important goal in the development of cancer nanotechnologies. In an effort to improve tumor targeting a method was developed to formulate cell membrane lipid-extracted nan...

    Authors: Hanan M. Alharbi and Robert B. Campbell
    Citation: AAPS Open 2018 4:5
    Content type: Research Published on:

  50. Regulatory convergence and cooperation among the authorities in the field of medical products (medicines and medical devices) are essential to deliver safe and efficacious products quickly to patients. APEC es...

    Authors: Sannie Siaw Foong Chong, John C. W. Lim and Toshiyoshi Tominaga
    Citation: AAPS Open 2018 4:4
    Content type: Commentary Published on:
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