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EISSN : 2364-9534
Total articles ≅ 34
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Andrea Allmendinger
Published: 11 June 2021
AAPS Open, Volume 7, pp 1-1; doi:10.1186/s41120-021-00035-0

, Helen Williams, Elke Debie, Mingkun Fu, Robert Bujalski, Fenghe Qiu, Yan Wu, Hanlin Li, Jin Wang, Cherokee Hoaglund-Hyzer, et al.
Published: 11 May 2020
AAPS Open, Volume 6, pp 1-11; doi:10.1186/s41120-020-00034-7

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 characteristics, especially to understand mechanisms of degradation. These modeling tools provide stability insights within weeks that could take months or years to understand using long-term stability conditions only. Despite their usefulness, the knowledge gained through these tools are not as broadly used to support regulatory filing strategies. This paper aims to communicate how industry has used RBPS data to support regulatory submissions and discuss the regulatory feedback that was received.
Thomas Stangler,
Published: 10 September 2019
AAPS Open, Volume 5, pp 1-6; doi:10.1186/s41120-019-0033-9

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 facilitate such evaluations. However, there is no regulatory consensus on a quantitative and scientifically justified definition and an underlying hypothesis of a statistically equivalent quality. The latter is essential to calculate operating characteristics of different approaches. This article proposes a hypothesis for establishing statistically equivalent quality which is concordant with current regulations. It also describes a tool which allows comparisons of different statistical approaches or tests by calculating the operating characteristics for false acceptance and false rejection rates of a claim for statistically equivalent quality. These error rates should be as low as possible to allow a meaningful application of a statistical approach in regulatory decision making. The described tool can be used to compare different statistical approaches for their suitability and may also facilitate the discussion and development of statistical approaches for comparing quality attributes in similarity assessments in general.
Lukas Roth, Kevin B. Biggs,
Published: 8 July 2019
AAPS Open, Volume 5; doi:10.1186/s41120-019-0031-y

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 Authorities and their partners leverage screening technologies to detect substandard and falsified medicines in the field and eliminate them from the medical product supply chain. An arsenal of different screening technologies has been developed to evaluate a variety of medicine quality attributes and performance characteristics, applying visual, physical and chemical analyses. Selecting the most effective screening technologies for a given quality challenge requires consideration of several practical, technical, and scientific factors, such as the type of medicines screened, the requirements of the screening technology, and the type of information needed. More widespread adoption of screening technologies will be facilitated by improved workforce development, technological advancements, and the development of a more robust supporting regulatory framework.
Published: 22 January 2019
AAPS Open, Volume 5; doi:10.1186/s41120-019-0030-z

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 reconstitute KCl dry syrup as a commercially viable alternative to currently available KCl syrup. We explored the potential of Eudragit E100 as a taste-masking polymer to coat and improve the palatability of the KCl. With the help of fluid bed processor, KCl was coated with the solution containing varying amounts of Eudragit E100 (4, 6, 10 and 15%). Coating with 10% polymer solution enabled optimal fluid bed processing, higher entrapment of the KCl (81%) and better in vitro release profile in 0.1 N HCl and pH 6.8 phosphate buffer. A dry syrup formulation containing Eudragit E100 coated KCl with good physical and chemical stability in dry and reconstituted state was developed. The palatability of the optimized formulation and commercially available KCl syrup was evaluated using the Electronic Taste Sensing Machine. The developed formulation showed~ 2-fold better taste-masking compared to the commercial KCl syrup. Thus, present investigation describes the development of an effective alternative to the current KCl syrup that can offer better palatability, stability and patient compliance.
, Alexandra Beumer Sassi
Published: 12 December 2018
AAPS Open, Volume 4; doi:10.1186/s41120-018-0029-x

Brazil, the largest country in South America, has become the second largest pharmaceutical market in the emerging world. The Brazillian Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria - ANVISA) was created in 1999 with the primary goal to protect and promote public health surveillance over products and services in Brazil. The governing body and structure of this new regulatory agency will be the aims of this paper, where the authors hope to share their understanding on the regulatory processes and its significant importance of this agency.
, For The Aaps Leadership, Christopher R. McCurdy, Dale Eric Wurster, Binodh S. DeSilva, Annette Bak, Reina Bendayan, , Allen C. Templeton, William Weiser
Published: 3 November 2018
AAPS Open, Volume 4; doi:10.1186/s41120-018-0028-y

Thomas Weinhold, , , Jessica Schiro, Sylvia Pelayo,
Published: 18 October 2018
AAPS Open, Volume 4; doi:10.1186/s41120-018-0027-z

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 usability deficits. To minimize this type of problem, the identification of potential use errors is an important and critical task in usability engineering. The aim of this systematic, qualitative literature review was to identify and catalog use errors related to disposable auto-injection devices. The key terms “auto-injector”, “usability”, and “safety/errors” were used to search in the PubMed and Scopus databases for articles from peer-reviewed journals and conference proceedings published in English or French between 2000 and 2017. Use errors, close calls, and operational difficulties were identified, extracted and hierarchically classified. The analysis showed that of the 1415 initially identified publications, 38 met all the eligibility criteria. A qualitative analysis identified 232 instances of use errors and close calls, which were classified into 10 main categories and then 39 subcategories. The present results could be used to guide the design, evaluation and risk analyses of disposable auto-injection devices. Our approach is in line with the European Union’s latest regulations on improving the safety of medical devices - especially those concerning transparency and traceability.
Maribel Beaumont, Daniela Tomazela, Douglas Hodges, Grigori Ermakov, Edward Hsieh, Isabel Figueroa, On-Yee So, Yaoli Song, Huiping Ma, Svetlana Antonenko, et al.
Published: 8 August 2018
AAPS Open, Volume 4; doi:10.1186/s41120-018-0026-0

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 function, and optimal pharmacokinetic properties. Building on these inherent antibody properties, the design and development of antibody-drug conjugates (ADCs) with improved or gained therapeutic activity and safety has been successfully demonstrated in oncological applications. There is enormous potential for this new type of hybrid biologics but there are also significant engineering, manufacturing and bioanalytical challenges. In this manuscript, we highlight the range and diversity of assays that are critical to characterize the individual components of ADCs-linker, carrier, and payload. We discuss a series of in vitro and in vivo preclinical experimental approaches we implemented to characterize two anti-inflammatory steroid bearing ADCs, and an ADC bearing a modified glucagon-like peptide 1 receptor/glucagon receptor co-agonist peptide.
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