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  1. Content type: Research

    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

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  2. Content type: Review

    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

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  3. Content type: Research

    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

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  4. Content type: Review

    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

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  5. Content type: Research

    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

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  6. Content type: Research

    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

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  7. Content type: Commentary

    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

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  8. Content type: Research

    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

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  9. Content type: Meeting report

    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

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  10. Content type: Research

    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

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  11. Content type: Research

    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

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  12. Content type: Research

    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

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  13. Content type: Meeting report

    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

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  14. Content type: Meeting report

    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

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  15. Content type: Research

    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

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  16. Content type: Research

    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

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  17. Content type: Research

    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

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  18. Content type: Meeting report

    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

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  19. Content type: Commentary

    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

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  20. Content type: Research

    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

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  21. Content type: Commentary

    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

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  22. Content type: Erratum

    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

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

  23. Content type: Commentary

    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

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  24. Content type: Meeting report

    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

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

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