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 | Crommelin D.J.,Utrecht Institute for Pharmaceutical science | Shargel L.,Applied Biopharmaceutics LLC | And 13 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.


Strauch S.,Goethe University Frankfurt | Jantratid E.,Goethe University Frankfurt | Jantratid E.,Mahidol University | Dressman J.B.,Goethe University Frankfurt | And 6 more authors.
Journal of Pharmaceutical Sciences | Year: 2011

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release solid oral dosage forms containing mefloquine hydrochloride as the only active pharmaceutical ingredient (API) are reviewed. The solubility and permeability data of mefloquine hydrochloride as well as its therapeutic use and therapeutic index, its pharmacokinetic properties, data related to the possibility of excipient interactions and reported BE/bioavailability studies were taken into consideration. Mefloquine hydrochloride is not a highly soluble API. Since no data on permeability are available, it cannot be classified according to the Biopharmaceutics Classification System with certainty. Additionally, several studies in the literature failed to demonstrate BE of existing products. For these reasons, the biowaiver cannot be justified for the approval of new multisource drug products containing mefloquine hydrochloride. However, scale-up and postapproval changes (HHS-FDA SUPAC) levels 1 and 2 and most EU type I variations may be approvable without in vivo BE, using the dissolution tests described in these regulatory documents. © 2010 Wiley-Liss, Inc.


Olivera M.E.,National University of Cordoba | Manzo R.H.,National University of Cordoba | Junginger H.E.,Naresuan University | Midha K.K.,University of Saskatchewan | And 4 more authors.
Journal of Pharmaceutical Sciences | Year: 2011

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of new multisource and reformulated immediate release (IR) solid oral dosage forms containing ciprofloxacin hydrochloride as the only active pharmaceutical ingredient (API) are reviewed. Ciprofloxacin hydrochloride's solubility and permeability, its therapeutic use and index, pharmacokinetics, excipient interactions and reported BE/bioavailability (BA) problems were taken into consideration. Solubility and BA data indicate that ciprofloxacin hydrochloride is a BCS Class IV drug. Therefore, a biowaiver based approval of ciprofloxacin hydrochloride containing IR solid oral dosage forms cannot be recommended for either new multisource drug products or for major scale-up and postapproval changes (variations) to existing drug products. © 2010 Wiley-Liss, Inc.


Rediguieri C.F.,Brazilian Health Surveillance Agency Anvisa | Porta V.,University of Sao Paulo | G. Nunes D.S.,Brazilian Health Surveillance Agency Anvisa | Nunes T.M.,Brazilian Health Surveillance Agency Anvisa | And 7 more authors.
Journal of Pharmaceutical Sciences | Year: 2011

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing metronidazole are reviewed. Metronidazole can be assigned to Biopharmaceutics Classification System Class I. Most BE studies that were identified reported the investigated formulations to be bioequivalent, indicating the risk of bioinequivalence to be low. Formulations showing differences in bioavailability showed dissimilarities in in vitro dissolution profiles. Furthermore, metronidazole has a wide therapeutic index. It is concluded that a biowaiver for solid IR formulations is justified, provided: (a) the test product and its comparator are both rapidly dissolving; (b) meet similarity of the dissolution profiles at pH 1.2, 4.5, and 6.8; (c) the test product contains only excipients present in IR drug products approved in International Conference on Harmonisation (ICH) or associated countries in the same dosage form; and (d) if the test product contains sorbitol, sodium laurilsulfate, or propylene glycol. The test product needs to be qualitatively and quantitatively identical to its comparator with respect to these excipients. © 2011 Wiley-Liss, Inc. and the American Pharmacists Association.


Strauch S.,Goethe University Frankfurt | Jantratid E.,Goethe University Frankfurt | Jantratid E.,Mahidol University | Dressman J.B.,Goethe University Frankfurt | And 6 more authors.
Journal of Pharmaceutical Sciences | Year: 2011

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing lamivudine as the only active pharmaceutical ingredient were reviewed. The solubility and permeability data of lamivudine as well as its therapeutic index, its pharmacokinetic properties, data indicating excipient interactions, and reported BE/bioavailability (BA) studies were taken into consideration. Lamivudine is highly soluble, but its permeability characteristics are not well-defined. Reported BA values in adults ranged from 82% to 88%. Therefore, lamivudine is assigned to the biopharmaceutics classification system (BCS) class III, noting that its permeability characteristics are near the border of BCS class I. Lamivudine is not a narrow therapeutic index drug. Provided that (a) the test product contains only excipients present in lamivudine IR solid oral drug products approved in the International Conference on Harmonization or associated countries in usual amounts and (b) the test product as well as the comparator product fulfills the BCS dissolution criteria for very rapidly dissolving; a biowaiver can be recommended for new lamivudine multisource IR products and major post-approval changes of marketed drug products. © 2011 Wiley-Liss, Inc.


Cristofoletti R.,State University Londrina | Nair A.,Goethe University Frankfurt | Abrahamsson B.,Astrazeneca | Groot D.W.,National Institute for Public Health and the Environment | And 5 more authors.
Journal of Pharmaceutical Sciences | Year: 2013

Literature data pertaining to the decision to allow a waiver of in vivo bioequivalence testing for the approval of immediate-release (IR) solid oral dosage forms containing efavirenz as the only active pharmaceutical ingredient (API) are reviewed. Because of lack of conclusive data about efavirenz's permeability and its failure to comply with the "high solubility" criteria according to the Biopharmaceutics Classification System (BCS), the API can be classified as BCS Class II/IV. In line with the solubility characteristics, the innovator product does not meet the dissolution criteria for a "rapidly dissolving product." Furthermore, product variations containing commonly used excipients or in the manufacturing process have been reported to impact the rate and extent of efavirenz absorption. Despite its wide therapeutic index, subtherapeutic levels of efavirenz can lead to treatment failure and also facilitate the emergence of efavirenz-resistant mutants. For all these reasons, a biowaiver for IR solid oral dosage forms containing efavirenz as the sole API is not scientifically justified for reformulated or multisource drug products. © 2012 Wiley Periodicals, Inc.


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.

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