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  1. Research

    Comparison of rates of nausea side effects for prescription medications from an online patient community versus medication labels: an exploratory analysis

    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 ...

    David A. Blaser, Stephanie Eaneff, James Loudon-Griffiths, Stephanie Roberts, Paulina Phan, Paul Wicks and James Weatherall

    AAPS Open 2017 3:10

    Published on: 20 November 2017

  2. Research

    Plasma modification of microporous polymer membranes for application in biomimetic dissolution studies

    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...

    Michael M. Puppolo, Justin R. Hughey, Bruce Weber, Traciann Dillon, David Storey, Elizabeth Cerkez and Susan Jansen-Varnum

    AAPS Open 2017 3:9

    Published on: 24 October 2017

  3. Meeting report

    New directions in pharmaceutical amorphous materials and amorphous solid dispersions, a tribute to Professor George Zografi – Proceedings of the June 2016 Land O’Lakes Conference

    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...

    Ann Newman, Jayne E. Hastedt and Mehran Yazdanian

    AAPS Open 2017 3:7

    Published on: 11 August 2017

  4. Research

    Relative bioavailability of diazoxide, manufactured at two different international locations, in healthy participants under fasting conditions: an open-label, two-stage, adaptive, sequential two-period crossover study

    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...

    Martin Otto Behm, Jialin Xu, Deborah Panebianco and Paul Fackler

    AAPS Open 2017 3:3

    Published on: 5 May 2017

  5. Research

    Non-isothermal stability by linear heating: a fast method for preformulation stability screening of drugs at the discovery and development interface

    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...

    Agnes Kairer, Shaoxin Feng, Valentino J. Stella and Thomas K. Karami

    AAPS Open 2017 3:2

    Published on: 26 April 2017

  6. Meeting report

    Analytical approaches to ensure product quality -- AAPS Joint Face-to-Face Meeting of the Stability, the Pharmaceutical Impurities, and the CMC Statistics Focus Groups, April 6th, 2016 in Gaithersburg, MD

    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...

    Kim Huynh-Ba, Greg Larner, Helen Strickland, Dilip Choudhury, Yan Wu, Jeff Hofer, Zhenyu Wang and Timothy Schofield

    AAPS Open 2017 3:1

    Published on: 14 January 2017

  7. Commentary

    Development of an algorithm to identify mass production candidate molecules to develop children’s oral medicines: a North American perspective

    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 ...

    Varsha Bhatt-Mehta, Robert B. MacArthur, Raimar Löbenberg, Jeffrey J. Cies, Ibolja Cernak and Richard H. Parrish II

    AAPS Open 2016 2:8

    Published on: 7 November 2016

  8. Research

    Prediction of the changes in drug dissolution from an immediate-release tablet containing two active pharmaceutical ingredients using an accelerated stability assessment program (ASAPprime®)

    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...

    Hanlin Li, David Nadig, Andrew Kuzmission and Christopher M. Riley

    AAPS Open 2016 2:7

    Published on: 3 November 2016

  9. Commentary

    Scientific and regulatory approaches to confirm quality and improve patient perceptions of generic drug products in Japan

    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...

    Hiroko Shibata, Hiroyuki Yoshida, Ken-ichi Izutsu, Chikako Yomota, Yukihiro Goda and Haruhiro Okuda

    AAPS Open 2016 2:6

    Published on: 7 October 2016

  10. Meeting report

    Scope and relevance of a pulmonary biopharmaceutical classification system AAPS/FDA/USP Workshop March 16-17th, 2015 in Baltimore, MD

    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...

    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

    AAPS Open 2016 2:1

    Published on: 27 January 2016

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

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