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- 中文翻译
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Utilization of risk-based predictive stability within regulatory submissions; industry’s experience AAPS Open Pub Date : 2020-05-11 Megan McMahon; Helen Williams; Elke Debie; Mingkun Fu; Robert Bujalski; Fenghe Qiu; Yan Wu; Hanlin Li; Jin Wang; Cherokee Hoaglund-Hyzer; Donnie Pulliam
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
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Similarity assessment of quality attributes of biological medicines: the calculation of operating characteristics to compare different statistical approaches AAPS Open Pub Date : 2019-09-10 Thomas Stangler; Martin Schiestl
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
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Drug manufacturing and access to medicines: the West African story. A literature review of challenges and proposed remediation AAPS Open Pub Date : 2019-08-05 Abigail A. Ekeigwe
It is the right of all humans to have access to safe, quality and effective medicines. This article seeks to expound on the problems of drug manufacturing and challenges of accessing medicines in West Africa, and evaluate the strategies being adopted by international developmental partners and the governments to address them. West Africa is uniquely diverse in culture (having English, French and Portuguese
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Substandard and falsified medicine screening technologies AAPS Open Pub Date : 2019-07-08 Lukas Roth; Kevin B. Biggs; Daniel K. Bempong
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
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Development and evaluation of taste masked dry syrup formulation of potassium chloride. AAPS Open Pub Date : 2019-01-22 Madhur Kulkarni,Brijesh Vishwakarma,Samik Sen,Sandhya Anupuram,Abhijit A Date
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
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ANVISA: an introduction to a new regulatory agency with many challenges AAPS Open Pub Date : 2018-12-12 Kim Huynh-Ba; Alexandra Beumer Sassi
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
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The journey to AAPS 2020: a reflection from strategic planning to PharmSci 360 AAPS Open Pub Date : 2018-11-03 Joseph W. Polli; Christopher R. McCurdy; Dale Eric Wurster; Binodh S. DeSilva; Annette Bak; Reina Bendayan; Bernd Meibohm; Allen C. Templeton; William Weiser
Since its inception in 1986, the American Association of Pharmaceutical Scientists (AAPS) has grown to be one of the premier scientific societies for pharmaceutical scientists in industry, academia, government, and other institutions in North America, with a global outreach to scientists from more than 60 countries around the world. Due to the foresight of its founders, AAPS established itself as a
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Improving the safety of disposable auto-injection devices: a systematic review of use errors AAPS Open Pub Date : 2018-10-18 Thomas Weinhold; Marzia Del Zotto; Jessica Rochat; Jessica Schiro; Sylvia Pelayo; Romaric Marcilly
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
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Antibody-drug conjugates: integrated bioanalytical and biodisposition assessments in lead optimization and selection AAPS Open Pub Date : 2018-08-08 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; Eric Rimmer; Michael Judo; Franklin Vives; Jennifer H. Yearley; Christina Moon; Anthony Manibusan; Nick Knudsen; Andy Beck; Damien Bresson; Dennis Gately;
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
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Nano-formulations composed of cell membrane-specific cellular lipid extracts derived from target cells: physicochemical characterization and in vitro evaluation using cellular models of breast carcinoma AAPS Open Pub Date : 2018-07-23 Hanan M. Alharbi; Robert B. Campbell
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 nanoliposomes (CLENs). The main ingredients were extracted directly from the membrane of cancer cells. For this study we used three different breast cancer cell lines (4 T1, BT-20, and SK-BR-3).
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Developing key performance indicators to measure the progress of regional regulatory convergence and cooperation in Asia-Pacific Economic Cooperation (APEC) AAPS Open Pub Date : 2018-05-31 Sannie Siaw Foong Chong; John C. W. Lim; Toshiyoshi Tominaga
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 established the Regulatory Harmonization Steering Committee (RHSC) to advance this cause among member economies. This paper identifies four areas of appropriate regulatory practice in which APEC
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A randomized, open-label study assessing the bioequivalence of two formulations of Fingolimod 0.5 mg in healthy subjects AAPS Open Pub Date : 2018-03-09 Mario Tanguay; Thomas Fröhlich; Mathieu Drouin; Gerald Beuerle
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 present study was designed to assess bioequivalence between a fingolimod Test capsule formulation (Teva Argentina, formerly IVAX Argentina S.A.) and a Reference capsule formulation (Novartis Pharma
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Stability challenges not addressed by harmonized guidance – AAPS workshop of the stability focus group, April 3rd- 4th, 2017 in Rockville, MD AAPS Open Pub Date : 2018-02-14 Mohd M. Khan; Bowen Jiang; Anthony Mazzeo; Kim Huynh-Ba
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 Conference on Harmonization (ICH) Quality documents was held from April 3rd – 4th, 2017 in Rockville, MD. Seventeen subject matter experts (SME), from industry and the Food & Drug Administration (FDA)
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Assessment of clinical immunogenicity of inotuzumab ozogamicin in patients with non-Hodgkin lymphoma and acute lymphoblastic leukemia AAPS Open Pub Date : 2018-02-07 Darshana Jani; John Nowak; Ying Chen; Joseph Boni; Boris Gorovits
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 via an acid-labile linker. It was developed for the treatment of relapsed or refractory non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL). Based on the perceived relatively low
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Comparison of rates of nausea side effects for prescription medications from an online patient community versus medication labels: an exploratory analysis AAPS Open Pub Date : 2017-11-20 David A. Blaser; Stephanie Eaneff; James Loudon-Griffiths; Stephanie Roberts; Paulina Phan; Paul Wicks; James Weatherall
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 which patients experience medications in real world settings. However, the relationship between these two data sources has not been closely examined. To understand how rates of medication side
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Plasma modification of microporous polymer membranes for application in biomimetic dissolution studies AAPS Open Pub Date : 2017-10-24 Michael M. Puppolo; Justin R. Hughey; Bruce Weber; Traciann Dillon; David Storey; Elizabeth Cerkez; Susan Jansen-Varnum
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-permeation dissolution methodologies are widely used to model drug absorption. The current work evaluates polymer membrane surface modifications for production of biomimetic membranes to be employed
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AAPS Workshop: accelerating pharmaceutical development through predictive stability approaches, April 4–5, 2016 AAPS Open Pub Date : 2017-09-06 A. L. Freed; S. T. Colgan; J. D. Kochling; M. S. Alasandro
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 studies which can be used to predict product shelf-life (Waterman, Pharm Res 24:780–790, 2007; (Wu et al., AAPS Pharm Sci Tech,16:986–991, 2016); (Lavrich, Rapid Development of Robust Stability Models
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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 AAPS Open Pub Date : 2017-08-11 Ann Newman; Jayne E. Hastedt; Mehran Yazdanian
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 conference held in June 2016 was a tribute to the ground-breaking work of Emeritus Professor and Dean George Zografi of School of Pharmacy, University of Wisconsin-Madison. This paper provides
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Oral solid self-nanoemulsifying drug delivery systems of candesartan citexetil: formulation, characterization and in vitro drug release studies AAPS Open Pub Date : 2017-06-15 Halah Hussein Ali; Ahmed Abbas Hussein
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 (14–40%). Therefore, the paper aim was to prepare and evaluate solid self-nanoemulsifying drug delivery systems for candesartan cilexetil in order to improve its solubility, dissolution and stability
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A review of in vivo and in vitro aspects of alcohol-induced dose dumping AAPS Open Pub Date : 2017-06-07 Susan D’Souza; Stephen Mayock; Alger Salt
This review provides a comprehensive list of in vivo and in vitro studies that have investigated alcohol induced dose dumping (AIDD) in modified release dosage forms. Of the numerous classes of drugs commercially available as modified release products, opioids, centrally acting drugs, and drugs with a narrow therapeutic index present high risks from dose dumping, despite being formulated in a manner
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Oral nanoemulsions of candesartan cilexetil: formulation, characterization and in vitro drug release studies AAPS Open Pub Date : 2017-06-02 Halah Hussein Ali; Ahmed Abbas Hussein
Nanoemulsion is considered to be a new and exciting field of research that seeks to exploit the attractive properties of components to improve oral delivery of drugs like candesartan cilexetil used in the management of chronic diseases. Candesartan cilexetil is a lipophilic acidic drug with a half-life of about (5–10) hour and absolute bioavailability of (14–40%). For this reason, the study target
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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 AAPS Open Pub Date : 2017-05-05 Martin Otto Behm; Jialin Xu; Deborah Panebianco; Paul Fackler
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 selected parameters. However, true variance estimates are often not known and are, instead, based on published literature or pilot trials. An open-label, two-stage, adaptive, sequential two-period
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Non-isothermal stability by linear heating: a fast method for preformulation stability screening of drugs at the discovery and development interface AAPS Open Pub Date : 2017-04-26 Agnes Kairer; Shaoxin Feng; Valentino J. Stella; Thomas K. Karami
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 this study was to carry out a comprehensive experimental evaluation of the non-isothermal method against the conventional isothermal method for a fast preformulation stability screening. The
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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 AAPS Open Pub Date : 2017-01-14 Kim Huynh-Ba; Greg Larner; Helen Strickland; Dilip Choudhury; Yan Wu; Jeff Hofer; Zhenyu Wang; Timothy Schofield
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 Impurities Focus Group and the Chemistry, Manufacturing and Controls (CMC) Statistics Focus Group. Twenty two subject-matter-experts (SME) from the Industry and the Food & Drug Administration (FDA)
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Development of an algorithm to identify mass production candidate molecules to develop children’s oral medicines: a North American perspective AAPS Open Pub Date : 2016-11-07 Varsha Bhatt-Mehta; Robert B. MacArthur; Raimar Löbenberg; Jeffrey J. Cies; Ibolja Cernak; Richard H. Parrish
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 common interest in pediatric drug development and medicines-use systems developed a practical framework for identifying a list of active pharmaceutical ingredients (APIs) with the greatest market
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Prediction of the changes in drug dissolution from an immediate-release tablet containing two active pharmaceutical ingredients using an accelerated stability assessment program (ASAPprime®) AAPS Open Pub Date : 2016-11-03 Hanlin Li; David Nadig; Andrew Kuzmission; Christopher M. Riley
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 ASAPprime® program can also be used to predict the slow-down in dissolution of two APIs in an immediate release tablet. The tablets were pre-equilibrated at 25 °C at different relative humidities
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Scientific and regulatory approaches to confirm quality and improve patient perceptions of generic drug products in Japan AAPS Open Pub Date : 2016-10-07 Hiroko Shibata; Hiroyuki Yoshida; Ken-ichi Izutsu; Chikako Yomota; Yukihiro Goda; Haruhiro Okuda
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 financial burden for the national health insurance system, while at the same time avoiding undermining the quality of medical care. This article provides an overview of the regulatory approaches available
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FDA draft guidance on compounding animal drugs from bulk drug substances: a commentary AAPS Open Pub Date : 2016-07-07 Adel H. Karara
The statement made by Debra Schotik Chan in 2001 (Chan 2001) regarding the regulations for use of bulk drugs in animals being unclear was probably true until last year. In May 2015 FDA issued a draft guidance on compounding animal drugs from bulk drug substances (Guidance for Industry (Draft) (#230) 2015). The guidance included specific FDA mandated conditions for animal drug compounding for each of:
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Erratum to: Scope and relevance of a pulmonary biopharmaceutical classification system AAPS/FDA/USP Workshop March 16-17th, 2015 in Baltimore, MD AAPS Open Pub Date : 2016-05-10 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; Jeffry G. Weers
The original version of this article (Hastedt et al. 2016) contained an error. The twelfth author’s name was inadvertently misspelled. The correct spelling is Masahiro Sakagami. Hastedt JE, Per B, Clark AR, William D, Anthony H, Guenther H, Kuehl PJ, Claus-Michael L, Peter M, Jason MC, Ralph N, Masahiro S, Weers JG (2016) Scope and relevance of a pulmonary biopharmaceutical classification system AAPS/FDA/USP
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Considerations and recommendations on traditional and non-traditional uses of excipients in oral drug products AAPS Open Pub Date : 2016-05-10 Panayiotis P. Constantinides; Subhashis Chakraborty; Dali Shukla
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 essential ingredients in drug products independently of the route of administration where both traditional and non-traditional uses are present. Beyond their traditional use as formulation and manufacturing
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Solid form changes during drug development: good, bad, and ugly case studies AAPS Open Pub Date : 2016-02-25 Ann Newman; Robert Wenslow
The relevance of solid form in drug development has been well established over time. In order to fully understand drug properties, attention has been paid to solid state structure of drug molecules and their relationship to the drug formulation. While each drug developer has had their own strategies and workflows for screening and choosing solid forms of drug molecules, the industry is aware of instances
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Scope and relevance of a pulmonary biopharmaceutical classification system AAPS/FDA/USP Workshop March 16-17th, 2015 in Baltimore, MD AAPS Open Pub Date : 2016-01-27 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; Jeffry G. Weers
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 timelines. This elegant, science-based approach is based on three in vitro parameters representing a combination of drug substance physicochemical and physiological properties with respect to