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Korenevsky A.,University of Waterloo | Vaillancourt R.,Childrens Hospital of Eastern Ontario | Pouliot A.,Childrens Hospital of Eastern Ontario | Revol M.,Childrens Hospital of Eastern Ontario | And 5 more authors.
Canadian Journal of Hospital Pharmacy | Year: 2013

Objectives: To catalogue pictograms used to label drugs in clinical practice; to identify the common graphic elements for defined categories of pictograms, by performing a semiotic analysis (studying how signs are perceived and how they should be designed); to identify the key graphic elements common to pictograms preferred by users; and to develop suggestions for future pictogram design on the basis of users' input.Methods: Literature and Internet searches were performed to identify pictograms and pictogram categories. A call for pictograms was also circulated through the International Pharmaceutical Federation (FIP). Youth at a Canadian pediatric hospital were asked to rate pictograms (including storyboards and prescription labels generated by FIP pictogram software) in terms of how best they represented their intended meanings. Pictograms for which at least 80% of participants "somewhat agreed", "agreed", or "strongly agreed" that the graphic conveyed the intended meaning were designated as "preferred" and were selected for analysis. Elements appearing in at least 50% of these preferred pictograms were highlighted as key graphic elements for design of future pictograms.Results: In total, 21 categories were identified for pictograms used in clinical practice, and a total of 204 pictograms were analyzed. Eighty-six participants took part in the survey. For each pictogram category, certain elements were identified as "preferred" and as "key graphic elements", whereas other elements met neither designation. For all 21 pictogram categories, at least 80% of survey respondents agreed that the FIP storyboard conveyed the intended meaning.Conclusions: Certain key, preferred graphic elements are required for pharmaceutical pictograms to convey their intended meaning. The overlap between preferred and key pictogram elements indicates that both must be considered in development of future pictograms. Redesign of existing pictograms with consideration of the best semiotic elements is in progress.Background: Communicating health-related instructions with pictograms is useful, but such graphics can be interpreted in different ways. It is crucial to understand which pictogram components are best for accurate communication.

Gajendran J.,PHAST GmbH | Gajendran J.,Johannes Gutenberg University Mainz | Kramer J.,PHAST GmbH | Shah V.P.,International Pharmaceutical Federation | And 7 more authors.
Journal of Pharmaceutical Sciences | Year: 2015

Literature data relevant to the biopharmaceutical properties of the active pharmaceutical ingredient (API) nifedipine are reviewed to evaluate whether a waiver of in vivo bioequivalence (BE) testing of immediate-release (IR) dosage forms formulated as tablets and soft gelatin capsules is warranted. Nifedipine's solubility and permeability, its therapeutic use and index, pharmacokinetics, food drug interactions, and any reported BE/bioavailability problems were all taken into consideration. Solubility and BA data indicate conclusively that nifedipine is a class II substance of biopharmaceutics classification system (BCS) and that the formulation of drug product plays a key role on the dissolution characteristics of the API. Therefore, a BCS biowaiver-based approval of nifedipine containing IR oral dosage forms cannot be recommended for reformulated/new multisource drug products or for major scale-up and postapproval changes to the existing drug products. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:3289-3298.

Karalis V.,Thriassio General Hospital | Magklara E.,KLEVA Pharmaceuticals SA | Shah V.P.,International Pharmaceutical Federation | MacHeras P.,National and Kapodistrian University of Athens
Pharmaceutical Research | Year: 2010

This is a summary report of the conference on drug absorption and bioequivalence issues held in Titania Hotel in Athens (Greece) from the 28 th to the 30th of May 2009. The conference included presentations which were mainly divided into three sections. The first section focused on modern drug delivery systems such as polymer nanotechnology, cell immobilization techniques to deliver drugs into the brain, nanosized liposomes used in drug eluting stents, encapsulation of drug implants in biocompatible polymers, and application of differential scanning calorimetry as a tool to study liposomal stability. The importance of drug release and dissolution were also discussed by placing special emphasis on camptothecins and oral prolonged release formulations. The complexity of the luminal environment and the value of dissolution in lyophilized products were also highlighted. The second session of the conference included presentations on the Biopharmaceutics Classification Scheme (BCS), the Biopharmaceutics Drug Disposition Classification System (BDDCS), and the role of transporters in the classification of drugs. The current status of biowaivers and a modern view on non-linear in vitro-in vivo (IVIVC) correlations were also addressed. Finally, this section ended with a special topic on biorelevant dissolution media and methods. The third day of the conference was dedicated to bioequivalence. Emphasis was placed on high within-subject variability and its impact on study design. Two unresolved issues of bioequivalence were also discussed: the use of generic antiepileptic drugs and the role of metabolites in bioequivalence assessment. Finally, the conference closed with a presentation of the current regulatory status of WHO and EMEA. © 2010 Springer Science+Business Media, LLC.

Chen M.-L.,U.S. Food and Drug Administration | Shah V.P.,International Pharmaceutical Federation | Ganes D.,Taro Pharmaceuticals | Midha K.K.,International Pharmaceutical Federation | And 20 more authors.
Clinical Therapeutics | Year: 2010

Background: Modified-release (MR) products are complex dosage forms designed to release drug in a controlled manner to achieve the desired efficacy and safety profiles. Inappropriate control of drug release from such products may result in reduced efficacy or increased toxicity. Objective: This paper is a summary report of the American Association of Pharmaceutical Scientists, International Pharmaceutical Federation, and Product Quality Research Institute workshop titled "Challenges and Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products", held October 1-2, 2009, in Baltimore, Maryland. Methods: The workshop provided an opportunity for pharmaceutical scientists from academia, industry, and regulatory agencies to discuss current regulatory expectations and industry practices for evaluating the pharmaceutical equivalence and bioequivalence of oral MR products. Results: In the case of conventional monophasic MR formulations, the current regulatory approaches and criteria for bioequivalence evaluation were considered adequate for the assessment of therapeutic equivalence and inter-changeability of drug products. Additional measures may occasionally be needed to determine the bioequivalence of multiphasic MR products. The metric of partial AUC proposed by the US Food and Drug Administration received broad support as an additional measure for evaluating bioequivalence of multiphasic MR products designed to have a rapid onset of drug action followed by sustained response. The cutoff for partial AUCs may be based on the pharmacokinetic/pharmacodynamic or pharmacokinetic/ response characteristics of the products under examination. If the new metric is highly variable, the bioequivalence limits may be set based on the known within-subject vari- ability for the reference product. Conclusions: The current regulatory approaches and criteria for bioequivalence evaluation were considered adequate for the assessment of therapeutic equivalence and interchangeability of conventional monophasic MR products. Additional measures may occasionally be needed to establish the bioequivalence of multiphasic MR products, and development of such measures is an important objective. The metric of partial AUC was proposed for products designed to have a rapid drug action followed by sustained response. © 2010 Excerpta Medica Inc.

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