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During the past three decades the world has been witness to an alarming increase in the shortage of drugs and biomedical products in the field of anesthesia and surgical care. This situation can be particularly challenging when there are no therapeutic alternatives available, as is the case with some supplies and drugs for perioperative use. Anesthesiologists, who play a crucial role in the preparation of the drugs they administer, are particularly aware of these shortages. The reasons for these shortages are diverse and involve problems in supply, demand and government regulation. Among the causes identified are the increase in demand, bidding systems and the sustainability challenges faced by pharmaceutical companies. It is essential to understand these causes in order to seek strategies to reduce the risk of shortages of medicines and supplies. Addressing this challenge requires improving supply chain management, fostering transparency in information on stock-outs, promoting local production of medicines, and strengthening procurement and distribution regulations and policies. The solution to this problem requires a comprehensive and collaborative approach, with multiple stakeholders working together to ensure adequate access to needed medications in the anesthesia and surgical care setting. [ABSTRACT FROM AUTHOR]

Lamivudine is one of the most prescribed drugs in the world, and is used to treat human immunodeficiency and hepatitis B. This study aimed to evaluate the quality attributes and compare the dissolution profiles of two batches (A and B) of generic lamivudine 150 mg tablets with the innovator drug Epivir 150 mg tablets. We conducted an analytical, experimental, cross-sectional study, and used a spectrophotometric method at a wavelength of maximum absorption (λ) corresponding to 270 nm, to measure the percentage of dissolved drug. The study evaluated identification, content, dissolution and mass uniformity. Apparatus 2 USP (Paddle) 75 rpm, 900 mL of dissolution medium (37 ± 0.5 °C) was used in three dissolution media: pH 1.2; 4.5 and 6.8. Samples of 5 mL were obtained at 5, 10, 15, 20 and 30 min. Both batches of generic lamivudine (A and B) were found to have the same dissolution kinetic profile as the innovator drug. Both formulations met the criteria of very fast dissolving (85% dissolved in 15 min), and fast dissolving (85% dissolved in 30 min) drugs. Therefore, it was not necessary to calculate the similarity factor. We concluded that generic drugs A and B are in vitro equivalents to the innovator drug Epivir. [ABSTRACT FROM AUTHOR]

The medicines’ interchangeability represents a necessity in developing countries, because it offers the possibility of accessing lower cost products, it allows to ensure efficacy and safety in pharmacotherapeutic treatments. The study gather researches carried out in the Peruvian state published in high-impact databases such as Scielo, Sciencedirect, Scopus and Pubmed. Of the 553 researches found, only 10 articles met the inclusion and exclusion criteria, drugs such as diazepam, prednisone, amoxicillin, doxycycline, fluconazole, phenytoin sodium, alprazolam, amlodipine, carbamazepine sodium, glibenclamide, moxifloxacin and acetylsalicylic acid were identified. All the articles analyzed the dissolution profile by calculating the similarity factor f2, while, in other cases, they estimated parameters such as weight variation, friability, hardness, quantification, content uniformity, and dissolution profile. The results show that 9 drugs included in the study were analyzed by in vitro studies at different pH (1.2; 4.5 and 6.8), and complied with presenting a similarity factor f2 greater than 50. It is concluded that, the interchangeability of medicines in the Peruvian state is still in process, and that, through strategic alliances with the private sector, a greater number of pharmaceutical alternatives could be had in the patient's recovery. [ABSTRACT FROM AUTHOR]

Introduction: Knowledge and perception towards generic drugs are topics that emerge as an important factor to explore in medical students. Objective: To determine the differences between medical students from public and private universities on the perception and use of Generic Pharmaceutical Specialties (GFE). Materials and methods: A quantitative observational, cross-sectional, analytical and comparative study was conducted in a universe of 858 students enrolled during 2019-2020 in five medical schools in the Mexican state of Tabasco. Through Google Forms, data were collected from a self-applied form based on a previously validated questionnaire. Descriptive statistics were used to assess student perceptions, and nonparametric tests through an analysis model for difference of means to compare the result between universities. Results: The perception of the dimensions of quality (= 12,51) and efficacy (=6,06) shows an indecisive position in general. On reliability (=6,99), students agreed. The dimensions of preference-experience (=10.649) and accessibility (=7,01), place students in the group of undecideds. In the comparison of means of the GFE perception scale (student's t test), the public university presented a low mean (=24,72), while in the group of private universities it was higher (=26,06). Regarding the use of GFE, the public university presented a mean =38,22, while the group of private universities was lower (=36,70). Conclusions: It is necessary to include in the curricular contents of future medical professionals more information on quality, safety and efficacy of GFE, which will contribute to raising the level of confidence in their prescription. [ABSTRACT FROM AUTHOR]

Generic drugs play an important role in healthcare systems as they represent an effective and more affordable alternative for the population. In Peru, a regulation of interchangeability of generic drugs (also called multisource drugs) was stablished to define the procedures and requirements for developing in vivo and in vitro therapeutic equivalence studies, following the gradual application approach and sanitary risk criteria. Compliance with the new regulation will allow greater access to effective, safe and quality generic drugs. Meanwhile, drugs continue to be marketed in the absence of therapeutic equivalence studies. Findings show that some drugs failed in in vivo and in vitro comparisons with the reference product. This regulation represents a great challenge for manufacturers and holders of sanitary registrations in order to demonstrate the interchangeability of their pharmaceutical products with the reference product. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the acceptance of generic drugs in the population of Diadema, and identify factors that interfere in their choice, aiming at an improvement in assistance for these patients. Materials and methods: 203 participants were interviewed through a questionnaire containing 23 questions. The interviews were performed in Diadema city/São Paulo - Brazil. Data was expressed inpercentages; however, Chi-square test was also used for some associations and a 95% confidence interval was considered. Results: Most interviewees declared having satisfactory knowledge about generic drugs and reported previous use of it. Eighty-one-point three percent of interviewed people reported that generic drugs had present the expected therapeutic effect, and 85.7% informed they believed in the safety of these drugs. The pharmacy/drugstore was the principal mean of communication to transmit information about generic medications, and a relation was observed between socioeconomic conditions and knowledge/use of these drugs. Conclusion: The studied population showed good acceptance and satisfactory knowledge about generic drugs and most of them believe in its safety. The price, the level of education, and the value of income of the population, and the low frequency of prescription, demonstrated to influence the consumption of generic drugs. Implementation of programs encouraging the prescription of these drugs and campaigns to enlighten information about generic drugs for the population could be beneficial for a better knowledge and use of them, ensuring access to health by all populations. [ABSTRACT FROM AUTHOR]

Background: The Brazilian Ministry of Health, by the National Policy on Medication, Ordinance 3916 from October 30th 1998, reinforces the Law of Generics of February 1999 (Law No. 9787 from February 10th, 1999, aiming, among other things, to reduce the prices and make access to medications easier for population). Objective: The main objective was to identify the level of knowledge of the population regarding generic drugs. Method: Descriptive, quantitative study, with 520 users interviewed in four health care units that implemented the Brazilian Family Health Program. Such units represent four health districts in Foz do Iguaçu, PR, Brazil. Results: Most of the interviewed know and/or have heard about generic drugs. For many people, the generic drug represents only a more affordable type of medication. Conclusion: The need for health education to clarify the population's questions was found, so they could identify and acquire their medication safely and with confidence. [ABSTRACT FROM AUTHOR]

Generic medicines give the chance to improve access to medicaments that the population needs, and the possibility of making public and private health programs more sustainable. Information and scientific evidence on this type of medicines has been selected in such a way that the readers - doctors, financiers, public and private organizations - can shape their own opinion and help take the most effective and efficient decisions. The relationship between the prices of these products and the protection of intellectual property through patents for medicines is a center of conflicts between the Pharmaceutical Industry and health systems. In the United States, the Hatch-Waxman Act has played a very important role in stimulating the development of generic drugs. By his side, the European Union (EU) has developed, through the European Medicines Agency (EMA), a homogenization in terms of authorization of medicines and exclusivity of data. [ABSTRACT FROM AUTHOR]

The aim of this study was to assess therapeutic equivalence through in vitro studies of four different brands of pharmaceutical products containing amoxicillin, doxycycline and fluconazole purchased in pharmacies from metropolitan Lima, establishing their interchangeability with a reference product (RP). A validated method of ultraviolet -- visible spectrophotometry was used to determine the dissolution profile. The similarity factor (f2) was used to establish therapeutic equivalence evaluated by in vitro studies, considering two formulations as equivalents if the values were within 50 and 100. The four brands of doxycycline studied were equivalents in vitro to RP. Only two of the four brands of Amoxicillin were equivalent in vitro to RP and none of Fluconazole brands were equivalent in vitro to PR. Therefore, there are some pharmaceutical products containing amoxicillin and fluconazole which are available in the national market and do not meet with therapeutic equivalence evaluated by in vitro studies, in other words, they are not interchangeable. [ABSTRACT FROM AUTHOR]

Introduction: The Colombian national pharmaceutical policy establishes as a strategy the generation of greater pharmaco-epidemiological research at the national level, especially in the case of antibiotic drugs. Objective: To provide local pharmaco-epidemiological evidence regarding the effectiveness, conditions of use and safety of generic meropenem and cefepime in a tertiary hospital in Bogotá. Materials and methods: We conducted a descriptive, longitudinal and retrospective drug utilization study. The data were collected from the medical histories of all the patients who had cefepime or meropenem prescribed. Results: We included 82 patients treated with cefepime and 91 treated with meropenem in the study. Most of the patients were in services different from the intensive care unit (taking cefepime: 59.8%, and meropenem: 52.7%). Only 21.9% of the patients treated with cefepime and 49% of those treated with meropenem were seen by an infectious disease specialist. The antibiogram was performed for 47% and 60% of the patients treated with cefepime and meropenem, respectively. The most frequent indication for cefepime were respiratory infections and for meropenem, genitourinary ones. Therapeutic success rates were 61.7% for cefepime and 63.0% for meropenem.Conclusions: This study contributes evidence regarding the therapeutic performance of two generic antibiotics used in tertiary hospitals. There were no reports of therapeutic failure during the study period. In the cases of non-response, pharmacokinetic alterations, unfavorable clinical conditions, and inappropriate choice of antimicrobial treatment were identified as frequent factors. [ABSTRACT FROM AUTHOR]

Introduction: the advertising of drugs and dietary supplements on television has a direct impact on the consumption patterns and the public health of the population, thus establishing the need to quantify the frequency of advertising of drugs and dietary supplements and additionally assess the content of the advertising regarding the current regulations of Invima, WHO and SIC. Methodology: during the week of June 27 to July 3, 2016 on a national television channel there were recorded all advertising related to drugs and dietary supplements broadcasted during the family strip from 7:00-21:30. 37 drug advertisements and 4 dietary supplement advertisements were analyzed, and frequency and total duration time were quantified. In addition, a checklist type matrix was used to evaluate compliance with the requirements of the Invima and WHO ethical criteria (only for drug commercials), to subsequently determine the percentage of compliance and non-compliance of each requirement. Results: it was obtained that during the study week the average duration of advertising space during the transmission of the family band was 237.4 minutes, equivalent to approximately 4 hours; and that the proportion of these advertising spaces spread in advertisements of drugs and dietary supplements, corresponded on average to 9.8% to advertisements for drugs and 0.8% to advertisements for dietary supplements. Non-compliance was identified with both the Invima requirements and the WHO ethical criteria, and finally five advertisements of drugs that were under supervision of the SIC by misleading advertising. Conclusions: it was possible to quantify the length of time spent in drug commercials and dietary supplements in relation to the total time of emission of the family band, evidencing a greater proportion in the advertisement of drugs than of dietary supplements [ABSTRACT FROM AUTHOR]

In the general population, there is a great controversy surrounding the use of innovative drugs and their copies called generic drugs. The objective of this study is to quantify the acceptance of patients from the General System of Social Security in Health of Colombia (SGSSS) to the prescription of generic drugs. A descriptive study was carried out with a transversal design. The universe was 63 men and 57 women, all adult patients who attended external consultation of the practice sites of the Faculty of Medicine of Cali-Colombia. It is concluded that if generic drugs are used, it is necessary that doctors and users have confidence in it, the results of the present study show that, although not in the majority, still a significant percentage of the consumers interviewed doubt the quality and the therapeutic results of generics. Worryingly, nearly a quarter of study participants think that generic drugs are fraudulent products. [ABSTRACT FROM AUTHOR]

This study aimed to analyze the evolution of the price of tenofovir (TDF) in Brazil considering the different initiatives for its reduction. The selection criteria for the case were: to have been subject to at least one strategy to overcome patent barrier, which in the case was the support to examination of the patent application (patent opposition); and have been subject of a local production Partnership for Productive Development (PDP). The main results suggest that patent opposition presented in 2005 and 2006 contributed to the decision to reject the patent application in 2009. Brazil is estimated to have paid around US$ 200 million more for the monopoly due to the patent pending application period. There was a reduction in the price of TDF between 2003 and 2013, including during the PDP (2011 to 2013). In 2010, after the PDP announcement, there was an additional 40% decrease in the price of the TDF offered by Gilead, which reflected in the price offered by the PDP. However, the price paid in Brazil for the national product was about ten times higher than the generic offered internationally. [ABSTRACT FROM AUTHOR]

Promoting the use of generic drugs can constitute a core instrument for countries' national pharmaceutical policies, one that reduces drug expenditure while expanding health care access. Despite the potential importance of such policy measures and the differences among national practices, scholars embarking on comparative analysis lack a roadmap for determining which dimensions of generic drug policy to assess and compare. This report fills that gap by considering national rules and regulations across four dimensions deemed crucial to any evaluation: demonstrated therapeutic equivalence; pharmaceutical packaging and labeling; drug prescription; and drug substitution. Furthermore, this report examines how the diverse interests of public and private sector stakeholders might shape generic drug policy and its implementation. To illustrate the challenges and conflicts behind policy development and implementation, this report focuses on the case of Brazil. [ABSTRACT FROM AUTHOR]

Introduction: Scientific and technological development, as well as the adoption of public policies aiming drugs cost reduction, has broadened the population's access to therapeutic alternatives. These alternatives include generic drugs, biosimilars, nanomedicines and non-biological complexes. Already marketed categories require their own procedures to guarantee their quality, therapeutic efficacy and safety. This article assesses the current Brazilian scenario in this regard, pointing to situations that will surely have to be addressed in a near future. Methodology: Data was obtained in the electronic databases MEDLINE, PubMed and SCIELO, searching for original articles, both Portuguese and English, retrospectively indexed back to 1999 using relevant search terms, both in English and in Portuguese. More than 50 scientific articles were found. Results and Discussion: Most of the evaluated articles point to problems both in the manufacture and in the control of generic and biosimilar drugs. In fact, scientific publications have proven these problems in the most varied markets including Brazilian. On the other hand, new drug forms are being created and need the development of legislation and specific methodologies to guarantee the quality of these products. An evaluation of the current Brazilian system of registration and quality control points out some flaws and especially the lack of a better structured and active pharmacovigilance in the country. Conclusion: The current scenario demonstrates the need of the responsible organs in the country to review the current system and improve it, as well as to prepare for the confrontation with other, even more complex, demands that are already under development. [ABSTRACT FROM AUTHOR]

In September 2014, Colombia issued standards for the evaluation of biological drugs within the framework of the marketing authorization process. The Colombian approach explicitly includes a fast track for evaluating competing biologicals, which caused great national and international controversy. This article explains the context that justifies the need for this fast-track approach, critically analyzes comparability as a paradigm for the evaluation of biogenerics, and shows that Colombia's position is not isolated and is based on global regulatory trends. [ABSTRACT FROM AUTHOR]

This paper intends in the first place to carry out a theorical description and analysis, in order to establish if in fact there is or there is not a conflict between the right to health, more specifically regarding the access to medications, and the exclusive rights granted by the pharmaceutical patents. In second place, and based on the performed investigation, the different views of the different bodies and relevant figures in the Colombian context are analyzed and compared. In order to finally conclude that although, in Colombia there is more than one position on the subject, the patent system does not affect in a negative way the access to medications, and therefore, the Constitutional right to health. [ABSTRACT FROM AUTHOR]

The World Health Organization (WHO) promotes the use of generic drug policies to foster competition in the pharmaceutical sector, reduce drug prices, and increase access to therapeutic drugs. However, little is known about how countries implement these policies. This article describes different terminology adopted by national regulatory authorities to define generic versus proprietary drug products in developing countries, including those in Latin America, and challenges that arise in their application of WHO guidelines, such as labeling issues. The author concludes that variation in generics terminology in these countries is a result of institutional context (i.e., the public sector setting as well as the body of laws and regulations that exists in the country) and policy legacies, such as intellectual property regimes, and highlights the need for further analysis of pharmaceutical regulations to improve understanding of the barriers and political implications of generic drug policies. [ABSTRACT FROM AUTHOR]

Objective: To assess the level of knowledge, perceptions and usage profile for generic drugs among laypersons. Methods: A crosssectional study was conducted with 278 volunteers (180 women and 98 men, aged 37.1±15.8 years). A questionnaire was drawn up with questions on their use, perceptions and knowledge of generic drugs. Results: Most respondents (99.6%) knew that generic drugs exist, but only 48.6% were able to define them correctly, while 78.8% of the respondents had some information about generics. This information was obtained mainly through television (49.3%). In terms of generic drug characteristics, 79.1% stated that they were confident about their efficacy, 74.8% believed that generic drugs have the same effect as branded medications, 88.8% said that generics were priced lower than branded medications, and 80.2% stated that they bought generic drugs because of price. With regard to drugs prescribed by medical practitioners, 17.6% of the participants said that their doctors never prescribed generics and only 7.5% confirmed that their doctors always prescribed generics. Conclusion: For the lay public, the sample in this study has sufficient knowledge of generic drugs in terms of definition, efficacy and cost. Consequently, the volunteers interviewed are very likely to use generics. Furthermore, the results of this study indicate that programs should be implemented in order to boost generic drug prescriptions by medical practitioners. [ABSTRACT FROM AUTHOR]

Latin America is adopting regulations that bear on medicinal costs and spending. The regulations have four main goals: i) to guarantee a competitive market, ii) to ensure affordability for individual consumers (commercial channel), iii) to contain public spending on medicines (institutional channel), and iv) to guarantee efficient spending on medicines. The experience of Latin America differs from that of countries in developed regions. In the latter, the countries tend to have similar policies, both in promoting generic medicines and in price control strategies, and in optimizing and containing pharmaceutical expense. In contrast, in Latin America, certain institutional weaknesses impede the consolidation and application of an effective regulatory policy. This paper reviews the experience gained through the adoption of economic regulations aimed at reducing spending and improving access to medicines, suggests lessons learned at the international level, and offers recommendations for the countries of Latin America. Its purpose is to offer key elements to decision-makers and the authorities of the countries concerned in pursuing economic regulation of medicines. [ABSTRACT FROM AUTHOR]

The aim of this study was to compare, by testing their pharmaceutical equivalence and dissolution profiles in vitro, eight generic medicines containing 750 mg paracetamol, marketed in the central region of Rio Grande do Sul (Brazil). Analyses were carried out in accordance with the monograph on paracetamol tablets in the Brazilian Pharmacopoeia (2010). The generic medicines A, B, D, E, F, G and H are pharmaceutically equivalent to the drug reference, since they passed all the tests they underwent. Of all the samples analyzed, only drug E did not have the same dissolution profile as the reference drug, a fact that may interfere with the interchangeability of these products, which is required of a drug being marketed as a generic. Regarding dissolution efficiency (DE), the ANOVA showed a significant difference between the products, so the Tukey test was applied, showing that only the generics A, F, G and H have the same DE as the reference drug. [ABSTRACT FROM AUTHOR]

The scientific paradigm concept of Thomas S. Kuhn combined with public policy perspective as a process of Enrique Saravia and the definition of a valuation model may contribute to a better form of public policy analysis of generic drugs in Brazil. Analysis of two paradigms identified in Brazil on the generic drug policy in an unbiased manner, in order to verify whether they meet their goals. The virtues and flaws for each paradigm are pointed up, so the most clearly possible and free policy scheme is showed. Definition of the analysis model adopted in order to facilitate its understanding and purpose. The two paradigms will be evaluated according to the logic model - the cognitive, normative and operational - in order to verify whether its objectives are being met, as well as to identify faults and virtues in implementing programs. Paradigm evaluation of patented drugs and generics. [ABSTRACT FROM AUTHOR]

This article reviews the European guidelines on drugs comparability that establish the methodology for verifying biosimilarity between the so-called biosimilar drugs and the reference biological medicinal product. Biosimilars are biological medicines similar but not identical to the original drugs and can be manufactured by any laboratory after the expiration of biotech drugs patent. The guidelines of the European Medicines Agency (EMA) and the International Conference on Harmonization (ICH) that must be considered in the development and approval of these drugs also are reviewed. It is shown that biosimilars cannot be considered as generic drugs, being necessary to conduct additional assays prior to obtain marketing authorization. [ABSTRACT FROM AUTHOR]

Objective: Comparison of the bioequivalence of three pharmaceutical formulations of fluticasone propionate nasal administered with a nasal spray (FANS). Materials y Methods: A randomized, open-label, single-dose, three-way crossover study in 60 healthy volunteers of both sexes between 18 and 55 years old. Subjects received a single intranasal dose (800 mcg) of FANS, Flonase®, and Flixonase® in 5 visits: screening, 3 dosing visits, and end of study. Forty-eight hours to 7 days were allowed between dosing visits. Blood was drawn for pharmacokinetics analysis at appropriate intervals. The primary pharmacokinetic parameter for determination of bioequivalence of the formulations was the area under the plasma concentration-time curve (AUC0-t). Secondary parameters included the maximum plasma concentration (Cmax). FANS was compared to Flonase® and to Flixonase® separately. Results: Bioequivalence between FANS and Flonase® (n=55) was demonstrated by the inverse log transformed AUC0-t (ratio FANS to Flonase® = 1.021; 90%CI, 0.88 to 1.19), and Cmax, (ratio = 0.995; 90% CI, 0.92 to 1.07), which are within the acceptable range of 0.80 to 1.25. Bioequivalence between FANS and Flixonase® (n=54) was also demonstrated for AUC0-t (ratio = 0.949; 90%CI 0.81 to 1.10) and Cmax (ratio = 0.939, 90% CI, 0.87 to 1.02). Active treatments were well tolerated and there were relatively few adverse events. Conclusions: A single dose of FANS 800 mcg is pharmacokinetically bioequivalent to both Flonase® and Flixonase® when administered to healthy subjects. The safety profile of FANS was consistent with that noted for Flonase® and Flixonase®. [ABSTRACT FROM AUTHOR]

Objective. The primary objective of this study was to establish the clinic equivalence of a new Fluticasone Propionate Aqueous Nasal Spray (FANS) compared to two commercially available active treatments of fluticasone propionate nasal spray (Flonase® and Flixonase®) during the mountain cedar (Juniperus ashei) pollen season in Texas. Material and methods. This was a multicenter, randomized, double-blind, double-dummy, active-controlled and placebo-controlled, parallel group study designed to investigate the safety and efficacy of FANS (200 mcg QD), Flonase® and Flixonase® (200 mcg QD) compared to placebo administered for 13 to 15 days. Patients recorded the total nasal symptoms dcores (TNSS) in a diary in the morning and evening every day. The primary endpoint was the patient-rated am and pm TNSS +1. Other key efficacy endpoints were patient-rated AM TNSS+1, patient-rated PM TNSS+1, and safety. Results. Mean TNSS values for Flonase® and Flixonase® were not statistically significantly different from FANS during any study day, over the entire treatment period, or at endpoint. Bioequivalence between FANS and Flonase® (ratio= 0.98, 90% CI 0.91 to 1.06) as well as FANS and Flixonase® (ratio=1.02, 90% CI 0.94 to 1.10) was demonstrated for the primary endpoint [Patient-Rated am and pm TNSS +1] as well as for the other key efficacy endpoints. Conclusions. The findings from this study support that FANS 200 mcg QD is therapeutically bioequivalent to both Flonase® and Flixonase® in the control of the symptoms of seasonal allergic rhinitis. [ABSTRACT FROM AUTHOR]

Through Free Trade Agreements, the economies of the United States of America (USA) and the European Union (EU) have been achieving a higher standard of protection of the intellectual property rights. This increases unduly the monopolist rights of the industry, restricting competition and limiting the access of new generic drugs. Peru has not been the exception to this process, subscribing a free trade agreement with the USA called Agreement of Commercial Promotion (APC) that involved the chapter of intellectual property, and in the same line, is now negotiating a second commercial agreement with the EU. In both cases, the presented proposals have been harmful for drug access, expressed in the clauses of the Aspects of Intellectual Property Related to the Commerce (ADPIC Plus). For some experts, there are certain complementarities between the goals of USA and those of the EU, while the first gets to increase the substantive standards such as the protection of testing data (achieved in the APC), the EU would strengthen the monitoring, thus ensuring the application of the obligations that have been acquired. This would result in a climbing of the pharmaceutical industry due to the widening of the intellectual property protection rights. The Peruvian State must guarantee the access to drugs through public policies that promote competition, ensuring the introduction of generics to the market. For this, it is necessary to prevent new obligations that attempt against access to these, by refusing new mechanisms of protection of the intellectual property rights in the free trade agreements. [ABSTRACT FROM AUTHOR]

The concepts that are the basis of the human rights (HHRR) are revised from the perspective of the iusnaturalism. HHRR are originated from the natural right, and are the group of attributes of men that are derived from his human nature, his life, that allow him to reason, be worthy, autonomous, free , in good health, have a language, express artistic and religious manifestations, showing due respect to other people and himself, inside the culture of the group to which he belongs. HHRR are linked to life, to health assistance , and on turn, to drug access, as it is contemplated in the Constitution. Drugs must be efficacious, safe and of high quality, must be replaced on time and the programs must be driven by efficient managers. We discuss about the HHRR and ethical aspects in many stages of history. We explore clinical trials for the study of innovating drugs, the ethical contents of documents such as the Universal Declaration of Human Rights, the Nuremberg Code, the Helsinki Declaration, the opinion of the Medical Confederation of Latin-America and the Caribbean regarding modifications that would affect the health of the study subjects. We refer to essential or generic drugs and novel drugs. We revise the law system and decisions concerning the drug patents in some countries of the region, peruvian experiences in the educational field and their future projections, opinions from economists and the relevance of generic drugs. A drug policy must care for the HHRR regarding life and health. [ABSTRACT FROM AUTHOR]

A generic medicine is a pharmaceutical product containing an active ingredient already known and previously developed and invented by others. The cost of these generic or multisource products should be less than their counterparts original. The clinical effects and the risk-benefit balance of a medicine do not depend exclusively on the activity of a pharmacologically active substance. Demonstration of bioequivalence of generic medicine is of great importance. In Europe and the United States generic medicine approval is based in the demonstration of bioequivalence through comparative bioavailability studies in vivo. These arguments are required for marketing approval of generic medicines by the European and North American health authorities. As a measure of the amount of drug absorbed it is used the area under the curve concentration-time (AUC), and as an indicator of the rate of absorption it is measured the peak concentration (Cmax) reached in the concentration-time curve and the time for its occurrence (Tmax). It is known as bioequivalence between two products when they have a comparable bioavailability in the appropriate experimental conditions. The ultimate goal of this process is to make quality drugs available to society and contribute to a more rational use of economic resources in the health system. [ABSTRACT FROM AUTHOR]

In terms of economics, implementing generic drug policy is nothing other than consolidating (or even, creating) drug markets that set competitive prices, the result of which favors public access to essential drugs. This article approaches the topic of generic drugs from the economic perspective by examining various regulatory models in order to evaluate and leverage generic drug policy implementation options as a mechanism for battling some of the markets' specific weaknesses. The conclusion is that there is no single unequivocal method for promoting the use of generic drugs, and that the most favorable way to integrate markets may be through a broad combination of alternatives. These alternatives are grouped and analyzed according to the market issues or challenges that must be overcome. Several options are then identified based on the degree of market consolidation to be obtained. [ABSTRACT FROM AUTHOR]

Objective. To determine the bioavailability of two dosage forms of ibuprofen 400mg tablets, for establishing if the multisource (generic) drug is bioequivalent to the reference (Motrin 400mg tablets). Materials and methods. It was designed an opened study, randomized, two periods, cross over, and seven days washout period, with 12 healthy volunteers (male and female), between 21 and 48 years old, who have taken one tablet of the multisource or reference tablets; according to randomization; with 200 mL of water. After drug intake 4 mL of blood was collected from each volunteer, for quantification of ibuprofen. The plasma samples with ibuprofen and sodium diclofenac (internal standard) were analyzed by liquid chromatography tandem mass spectrometry (LC-MS/MS) with negative ion electrospray ionization using selected reaction monitoring. The bioequivalence was established with pharmacokinetics parameters: area under the curve AUC(0-t), AUC (0-∞) and maximum concentration (Cmax). Results. According to statistical analysis were founded: AUCmultisource(0-t) = 86.85 (ug*h)/mL, AUCRef.(0-t) = 81.20 (ug*h)/mL, AUCmultisource(0-∞) = 88.67 (ug*h)/mL, AUCRef.(0-∞) = 82.83 (ug*h)/mL, Cmáxmultisource = 17.70 ug/mL, CmáxRef.=18.09 ug/mL, with intervals of 0.93-1.24 for AUC (0-t), 0.93-1.24 for AUC(0-∞) and 0.81-1.19 for Cmax. Conclusions. The values founded for AUC(0-t), AUC(0-∞) and Cmax are within the established limits by WHO and FDA (0,80 -1,25), so ibuprofen 400mg tables; multisource drug, is bioequivalent to Motrin 400mg tablets, with regard to both the rate and extent of absorption. [ABSTRACT FROM AUTHOR]

This study pretends to analyze the impact of the international commercial norms in the fill of the intellectual property of medicines, as a direct consequence of the negotiations between Colombia with United States in the TLC. In this way, taking into account the technological advances and the aperture of the globalization in the different aspects of the diary life, it is necessary to study the possible benefits and negative effects that could affect the public health and the access to the medicines. [ABSTRACT FROM AUTHOR]

Os Antimicrobianos são definidos como compostos naturais, sintéticos ou semi-sintéticos, cuja finalidade é prevenir ou tratar de doenças infecciosas causadas por micro organismos patogênicos. Ele é comercializado sob prescrição médica e possui um medicamento de referência. O medicamento de referência é um produto inovador no mercado, que possui sua própria marca comercial. Ele tem qualidade, eficácia e segurança comprovados cientificamente através de testes que são registrados junto ao órgão federal ANVISA. O objetivo do estudo é demonstrar a diferença de preços existente entre os medicamentos analisados. O valor dos medicamentos foi levantado através de pesquisa em drogarias, o que nos mostrou uma grande diferença de preço entre os medicamentos e quando comparado com o estudo que avaliou o princípio ativo, o medicamento com melhor custo benefício, são os similares [ABSTRACT FROM AUTHOR]