International Pharmaceutical Federation FIP

The Hague, Netherlands

International Pharmaceutical Federation FIP

The Hague, Netherlands
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Chen M.-L.,U.S. Food and Drug Administration | Shah V.P.,International Pharmaceutical Federation FIP | Ganes D.,Taro Pharmaceuticals | Midha K.K.,University of Saskatchewan | And 19 more authors.
European Journal of Pharmaceutical Sciences | Year: 2010

Modified-release products are complex dosage forms designed to release drug in a controlled manner to achieve desired efficacy and safety. Inappropriate control of drug release from such products may result in reduced efficacy or increased toxicity. This workshop provided an opportunity for pharmaceutical scientists from academia, industry and regulatory agencies to discuss current regulatory expectations and industry practices for demonstrating pharmaceutical equivalence and bioequivalence of MR products, further facilitating the establishment of regulatory standards for ensuring therapeutic equivalence of these products. © 2010.


Chen M.-L.,U.S. Food and Drug Administration | Shah V.P.,International Pharmaceutical Federation FIP | Crommelin D.J.,Utrecht Institute for Pharmaceutical science | Shargel L.,Applied Biopharmaceutics LLC | And 14 more authors.
AAPS Journal | Year: 2011

Regulatory approaches for evaluating therapeutic equivalence of multisource (or generic) drug products vary among different countries and/or regions. Harmonization of these approaches may decrease the number of in vivo bioequivalence studies and avoid unnecessary drug exposure to humans. Global harmonization for regulatory requirements may be promoted by a better understanding of factors underlying product performance and expectations from different regulatory authorities. This workshop provided an opportunity for pharmaceutical scientists from academia, industry and regulatory agencies to have open discussions on current regulatory issues and industry practices, facilitating harmonization of regulatory approaches for establishing therapeutic equivalence and interchangeability of multisource drug products. © 2011 American Association of Pharmaceutical Scientists.


Chen M.-L.,U.S. Food and Drug Administration | Shah V.P.,International Pharmaceutical Federation FIP | Crommelin D.J.,Utrecht Institute for Pharmaceutical science | Shargel L.,Applied Biopharmaceutics LLC | And 14 more authors.
European Journal of Pharmaceutical Sciences | Year: 2011

Regulatory approaches for evaluating therapeutic equivalence of multisource (or generic) drug products vary among different countries and/or regions. Harmonization of these approaches may decrease the number of in vivo bioequivalence studies and avoid unnecessary drug exposure to humans. Global harmonization for regulatory requirements may be promoted by a better understanding of factors underlying product performance and expectations from different regulatory authorities. This workshop provided an opportunity for pharmaceutical scientists from academia, industry and regulatory agencies to have open discussions on current regulatory issues and industry practices, facilitating harmonization of regulatory approaches for establishing therapeutic equivalence and interchangeability of multisource drug products. © 2011 Elsevier B.V. All rights reserved.


PubMed | University of Maryland, Baltimore, U.S. Food and Drug Administration, Tehran University of Medical Sciences, Goethe University Frankfurt and 5 more.
Type: Journal Article | Journal: Journal of pharmaceutical sciences | Year: 2016

Literature data relevant to the decision to allow a waiver of invivo bioequivalence (BE) testing for the approval of immediate release solid oral dosage forms containing ribavirin are reviewed. Ribavirin is highly soluble, but its permeability characteristics are not well defined. Therefore according to the Biopharmaceutical Classification System, and taking a worst case approach, ribavirin should be assigned to class III. As ribavirin is transported across the brush border membrane of the human jejunum by hCNT2, it shows saturable uptake in the intestine. However, no common excipients have been shown to compete for ribavirin absorption, nor have problems with BE of immediate release ribavirin formulations containing different excipients and produced by different manufacturing methods been reported in the open literature. So the risk of bioinequivalence caused by these factors appears to be low. Ribavirin is considered a narrow therapeutic index drug, as judged by comparing the minimum effective concentration and minimum toxic concentrations in blood. Although ribavirin would not be eligible for approval via a Biopharmaceutical Classification System-based biowaiver procedure according to todays guidances due to its narrow therapeutic index, the risks of biowaiving should be weighed against the considerable risks associated with studying BE of ribavirin products in healthy subjects.


PubMed | World Health Organization, University of Maryland, Baltimore, U.S. Food and Drug Administration, Institute of Preclinical and Clinical Pharmacology & Toxicology and 7 more.
Type: Journal Article | Journal: Journal of pharmaceutical sciences | Year: 2015

Literature and experimental data relevant for the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing levetiracetam are reviewed. Data on solubility and permeability suggest that levetiracetam belongs to class I of the biopharmaceutical classification system (BCS). Levetiracetams therapeutic use, its wide therapeutic index, and its favorable pharmacokinetic properties make levetiracetam a valid candidate for the BCS-based biowaiver approach. Further, no BE studies with levetiracetam IR formulations in which the test formulation failed to show BE with the comparator have been reported in the open literature. On the basis of the overall evidence, it appears unlikely that a BCS-based biowaiver approach for levetiracetam IR solid oral dosage forms formulated with established excipients would expose patients to undue risks. Thus, the BCS-based biowaiver approach procedure is recommended for IR solid oral dosage form containing levetiracetam, provided the excipients in the formulation are also present in products that have been approved in countries belonging to or associated with the International Committee on Harmonization and are used in their usual quantities, and provided the dissolution profiles of the test and reference product comply with the current requirements for BCS-based biowaivers.


Bates I.,University College London | John C.,Global Pharmacy Workforce Observatory | Bruno A.,International Pharmaceutical Federation FIP | Fu P.,University College London | Aliabadi S.,University College London
Human Resources for Health | Year: 2016

Background: The World Health Organization (WHO) estimates that there is a global healthcare workforce shortage of 7.2 million, which is predicted to grow to 12.9 million by 2035. Globally, people are living longer with multiple co-morbidities and require increased access and use of medicines. Pharmacists are a key component of the healthcare workforce, and in many countries, pharmacists are the most accessible healthcare profession. This paper identifies key issues and current trends affecting the global pharmacy workforce, in particular workforce distribution, country economic status, capacity, and workforce gender balance. Methods: National professional pharmacy leadership bodies, together with other contacts for professional bodies, regulatory bodies, and universities, were approached to provide country-level data on pharmacy workforce. A descriptive and comparative analysis was conducted to assess each country's pharmacy workforce. Results: A total of 89 countries and territories responded to the survey. To standardise the capacity measure, an analysis of the population density of pharmacists (per 10 000 population) was performed. The sample mean was 6 pharmacists per 10 000 population (n = 80). There is considerable variation between the surveyed countries/territories ranging from 0.02 (Somalia) to 25.07 (Malta) pharmacists per 10 000 population. African nations have significantly fewer pharmacists per capita. Pharmacist density correlates with gross national income (GNI) and health expenditure. The majority of pharmacists are employed in community settings, followed by hospital, industry-related, academia, and regulation. There is a greater proportion of females in the pharmacy workforce globally, with some WHO regions showing female representation of more than 65 % with an increasing trend trajectory. Conclusions: Pharmacy workforce capacity varies considerably between countries and regions and generally correlates with population- and country-level economic indicators. Those countries and territories with lower economic indicators tend to have fewer pharmacists and pharmacy technicians; this has implications for inequalities regarding access to medicines and medicine expertise. © 2016 The Author(s).


PubMed | International Pharmaceutical Federation FIP, Global Pharmacy Workforce Observatory and University College London
Type: Journal Article | Journal: Human resources for health | Year: 2016

The World Health Organization (WHO) estimates that there is a global healthcare workforce shortage of 7.2 million, which is predicted to grow to 12.9 million by 2035. Globally, people are living longer with multiple co-morbidities and require increased access and use of medicines. Pharmacists are a key component of the healthcare workforce, and in many countries, pharmacists are the most accessible healthcare profession. This paper identifies key issues and current trends affecting the global pharmacy workforce, in particular workforce distribution, country economic status, capacity, and workforce gender balance.National professional pharmacy leadership bodies, together with other contacts for professional bodies, regulatory bodies, and universities, were approached to provide country-level data on pharmacy workforce. A descriptive and comparative analysis was conducted to assess each countrys pharmacy workforce.A total of 89 countries and territories responded to the survey. To standardise the capacity measure, an analysis of the population density of pharmacists (per 10000 population) was performed. The sample mean was 6 pharmacists per 10000 population (n=80). There is considerable variation between the surveyed countries/territories ranging from 0.02 (Somalia) to 25.07 (Malta) pharmacists per 10000 population. African nations have significantly fewer pharmacists per capita. Pharmacist density correlates with gross national income (GNI) and health expenditure. The majority of pharmacists are employed in community settings, followed by hospital, industry-related, academia, and regulation. There is a greater proportion of females in the pharmacy workforce globally, with some WHO regions showing female representation of more than 65% with an increasing trend trajectory.Pharmacy workforce capacity varies considerably between countries and regions and generally correlates with population- and country-level economic indicators. Those countries and territories with lower economic indicators tend to have fewer pharmacists and pharmacy technicians; this has implications for inequalities regarding access to medicines and medicine expertise.


Charoo N.,AlFalah Life science Pvt. Ltd. | Cristofoletti R.,Brazilian Health Surveillance Agency Anvisa | Graham A.,LaGray Chemical Company | Lartey P.,LaGray Chemical Company | And 7 more authors.
Journal of Pharmaceutical Sciences | Year: 2014

Literature data pertaining to the decision to allow a waiver of in vivo bioequivalence (BE) testing requirements for the approval of immediate release (IR) solid oral dosage forms containing fluconazole as the only active pharmaceutical ingredient (API) are reviewed. The decision is based on solubility, dissolution, permeability, therapeutic index, pharmacokinetic parameters, pharmacodynamic properties, and other relevant data. BE/bioavailability (BA) problems and drug-excipients interaction data were also reviewed and taken into consideration. According to the biopharmaceutics classification system (BCS), fluconazole in polymorphic forms II and III is a BCS class I drug and has a wide therapeutic index. BE of test formulations from many different manufacturers containing different excipients confirmed that the risk of bioinequivalence because of formulation and manufacturing factors is low. It was inferred that risk can be further reduced if in vitro studies are performed according to biowaiver guidelines. Thus, it is concluded that a biowaiver can be recommended for fluconazole IR dosage forms if (a) fluconazole is present as polymorphic form II or III or any other form/mixture showing high solubility, (b) the selection of excipients be limited to those found in IR drug products approved in International Conference on Harmonisation (ICH) countries for the same dosage form and used in their usual amounts, and (c) both the test and comparator dosage form are very rapidly dissolving, or, rapidly dissolving throughout the shelf life with similar dissolution profiles at pH 1.2, 4.5, and 6.8. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.


Dahan A.,Ben - Gurion University of the Negev | Wolk O.,Ben - Gurion University of the Negev | Zur M.,Ben - Gurion University of the Negev | Amidon G.L.,University of Michigan | And 8 more authors.
Journal of Pharmaceutical Sciences | Year: 2014

The present monograph reviews data relevant to applying the biowaiver procedure for the approval of immediate-release multisource solid dosage forms containing codeine phosphate. Both biopharmaceutical and clinical data of codeine were assessed. Solubility studies revealed that codeine meets the "highly soluble" criteria according to World Health Organization (WHO), the European Medicines Agency (EMA), and the United States Food and Drug Administration (US FDA). Codeine's fraction of dose absorbed in humans was reported to be high (>90%) based on cumulative urinary excretion of drug and drug-related material following oral administration. The permeability of codeine was also assessed to be high in both Caco-2 monolayers and rat intestinal perfusion studies. The main risks associated with codeine, that is, toxicity (attributed to CYP2D6 polymorphism) and its abuse potential, are present irrespective of the dosage form, and do not need to be taken into account for bioequivalence (BE) considerations. Taken together, codeine is a class 1 drug with manageable risk and is a good candidate for waiver of in vivo BE studies. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.


PubMed | International Pharmaceutical Federation FIP
Type: Journal Article | Journal: Pharmaceutical research | Year: 2010

The Board of Pharmaceutical Sciences (BPS) of the International Pharmaceutical Federation (FIP) has developed a view on the future of pharmaceutical sciences in 2020. This followed an international conference with invited participants from various fields (academicians, scientists, regulators, industrialists, venture capitalists) who shared their views on the forces that might determine how the pharmaceutical sciences will look in 2020. The commentary here provides a summary of major research activities that will drive drug discovery and development, enabling technologies for pharmaceutical sciences, paradigm shifts in drug discovery, development and regulations, and changes in education to meet the demands of academia, industry and regulatory institutions for pharmaceutical sciences in 2020.

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