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  1. 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:

  2. 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:

  4. 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:

  5. 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:

  6. 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:

  8. 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:

  9. 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:

  10. 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:

  11. 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:

  13. 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:

  14. 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:

  16. 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:

  17. 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:

  20. 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:

  21. 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:

  22. 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:

  23. 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:

  24. Fingolimod is an oral agent approved for the treatment of relapsing forms of multiple sclerosis (MS), which has demonstrated efficacy in Phase III trials in patients with relapsing-remitting MS (RRMS). The pre...

    Authors: Mario Tanguay, Thomas Fröhlich, Mathieu Drouin and Gerald Beuerle
    Citation: AAPS Open 2018 4:3
    Content type: Research Published on:

  25. An American Association of Pharmaceutical Scientists (AAPS) workshop on stability challenges for clinical supplies and commercial distribution of drug product that are not addressed in the International Confer...

    Authors: Mohd M. Khan, Bowen Jiang, Anthony Mazzeo and Kim Huynh-Ba
    Citation: AAPS Open 2018 4:2
    Content type: Meeting report Published on:

  26. Inotuzumab ozogamicin (InO) is an antibody-drug conjugate composed of a recombinant, humanized immunoglobulin type G, subtype 4 (IgG4) antibody covalently bound to a semisynthetic derivative of calicheamicin v...

    Authors: Darshana Jani, John Nowak, Ying Chen, Joseph Boni and Boris Gorovits
    Citation: AAPS Open 2018 4:1
    Content type: Research Published on:

  27. While medication labels are considered the authoritative resource for medication information, emerging research suggests that patient-generated health data (PGHD) are a valuable tool to understand the ways in ...

    Authors: David A. Blaser, Stephanie Eaneff, James Loudon-Griffiths, Stephanie Roberts, Paulina Phan, Paul Wicks and James Weatherall
    Citation: AAPS Open 2017 3:10
    Content type: Research Published on:

  28. Biorelevant dissolution is an indispensable tool utilized during formulation development and optimization for the prediction of in vivo bioavailability of pharmaceutical agents. Within that framework, membrane...

    Authors: Michael M. Puppolo, Justin R. Hughey, Bruce Weber, Traciann Dillon, David Storey, Elizabeth Cerkez and Susan Jansen-Varnum
    Citation: AAPS Open 2017 3:9
    Content type: Research Published on:

  29. There has been significant growth in the use of modeling tools to accelerate development and enhance pharmaceutical quality. Among these are empirical and semi-empirical modeling of accelerated stability studi...

    Authors: A. L. Freed, S. T. Colgan, J. D. Kochling and M. S. Alasandro
    Citation: AAPS Open 2017 3:8
    Content type: Meeting report Published on:

  30. The University of Wisconsin-Madison June Land O’Lakes Conference on Research and Development is held every year and is recognized worldwide as a premier teaching conference for pharmaceutical scientists. The c...

    Authors: Ann Newman, Jayne E. Hastedt and Mehran Yazdanian
    Citation: AAPS Open 2017 3:7
    Content type: Meeting report Published on:

  31. Candesartan cilexetil is an ester prodrug antagonist to angiotensin II receptor type 1 (AT1) used in management of many cardiovascular diseases. The absolute bioavailability of candesartan cilexetil is about (...

    Authors: Halah Hussein Ali and Ahmed Abbas Hussein
    Citation: AAPS Open 2017 3:6
    Content type: Research Published on:

  34. Theoretically, calculating the sample size required for achieving the desired power is straightforward with true coefficient of variance (CV) estimates and true test/reference geometric mean ratios (GMRs) of s...

    Authors: Martin Otto Behm, Jialin Xu, Deborah Panebianco and Paul Fackler
    Citation: AAPS Open 2017 3:3
    Content type: Research Published on:

  35. The non-isothermal method for prediction of chemical stability of pharmaceuticals has been discussed in the literature for almost half a century but it has not yet been systematically evaluated. The purpose of...

    Authors: Agnes Kairer, Shaoxin Feng, Valentino J. Stella and Thomas K. Karami
    Citation: AAPS Open 2017 3:2
    Content type: Research Published on:

  36. An AAPS joint face-to-face meeting was held on April 6th, 2016 at MedImmune, Gaithersburg, MD. The meeting was organized by members of the Steering Committees of the Stability Focus Group, the Pharmaceutical I...

    Authors: Kim Huynh-Ba, Greg Larner, Helen Strickland, Dilip Choudhury, Yan Wu, Jeff Hofer, Zhenyu Wang and Timothy Schofield
    Citation: AAPS Open 2017 3:1
    Content type: Meeting report Published on:

  37. The gap in the commercially-available pediatric drug products and formulations suitable for children, especially those below the age of 6 years, is long recognized. A group of clinicians and scientists with a ...

    Authors: Varsha Bhatt-Mehta, Robert B. MacArthur, Raimar Löbenberg, Jeffrey J. Cies, Ibolja Cernak and Richard H. Parrish II
    Citation: AAPS Open 2016 2:8
    Content type: Commentary Published on:

  38. The computer program ASAPprime® has been used successfully for some time to predict the stability of active pharmaceutical ingredients (APIs) in solid-dosage forms. In this study, we have demonstrated that the AS...

    Authors: Hanlin Li, David Nadig, Andrew Kuzmission and Christopher M. Riley
    Citation: AAPS Open 2016 2:7
    Content type: Research Published on:

  39. The rapidly growing medical expense going with aging population in Japan requires the use of generic products derived from off-patent active pharmaceutical ingredients (APIs) formulations to reduce the financi...

    Authors: Hiroko Shibata, Hiroyuki Yoshida, Ken-ichi Izutsu, Chikako Yomota, Yukihiro Goda and Haruhiro Okuda
    Citation: AAPS Open 2016 2:6
    Content type: Commentary Published on:

  41. Authors: Jayne E. Hastedt, Per Bäckman, Andrew R. Clark, William Doub, Anthony Hickey, Guenther Hochhaus, Phil J. Kuehl, Claus-Michael Lehr, Peter Mauser, Jason McConville, Ralph Niven, Masahiro Sakagami and Jeffry G. Weers
    Citation: AAPS Open 2016 2:4
    Content type: Erratum Published on:

    The original article was published in AAPS Open 2016 2:1

  42. Excipients represent diverse classes of molecules, small molecules or macromolecules, with versatile structures within a given class and are from natural, semi-synthetic and synthetic sources. They are essenti...

    Authors: Panayiotis P. Constantinides, Subhashis Chakraborty and Dali Shukla
    Citation: AAPS Open 2016 2:3
    Content type: Commentary Published on:

  44. The Biopharmaceutics Classification System (BCS), developed in the 1990s for oral immediate release drugs, is utilized by R&D scientists and regulators to streamline product development and regulatory approval...

    Authors: Jayne E. Hastedt, Per Bäckman, Andrew R. Clark, William Doub, Anthony Hickey, Guenther Hochhaus, Phil J. Kuehl, Claus-Michael Lehr, Peter Mauser, Jason McConville, Ralph Niven, Masahiro Sakagimi and Jeffry G. Weers
    Citation: AAPS Open 2016 2:1
    Content type: Meeting report Published on:

    The Erratum to this article has been published in AAPS Open 2016 2:4

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