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1.
PLoS One ; 16(9): e0257625, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34551002

RESUMO

INTRODUCTION: Quality of medicines in both developed and developing countries is sometimes compromised due to infiltration of counterfeit, substandard or degraded medicines into the markets. It is a public health concern as poor quality medicines endanger public health where patients are exposed to chemical toxins and/or sub-therapeutic doses. This could lead to reduced treatment efficacy and promote development of drug resistance. Co-trimoxazole, a fixed dose combination of sulfamethoxazole and trimethoprim, is a broad spectrum for bacterial diseases and is also used as a prophylaxis for opportunistic infections in HIV infected individuals. This study evaluated quality of selected co-trimoxazole suspension brands marketed in Nairobi County, Kenya. METHODS: A total of 106 samples were collected, categorized into 15 brands and evaluated for active pharmaceutical ingredient content (API) and pH following United States Pharmacopeia. Assay for API was conducted using High Performance Liquid Chromatography. Results were compared with pharmacopeia references. Visual examination of labels and confirmation of retention status of the brands with Pharmacy and Poisons Board retention register was carried out. RESULTS: The samples were primarily of local origin (86.7%). On October 23, 2019, retention status of six of the fifteen brands documented were no longer listed in the Pharmacy and Poisons Board retention register. Of the 106 samples tested 70.6% and 86.8% were compliant with United States Pharmacopeia (USP) specifications for pH and API respectively while 84.0% adhered to packaging and labelling requirements. CONCLUSION: This study has demonstrated that majority of co-trimoxazole suspensions tested were compliant with USP requirements. Additionally, it has provided evidence of poor quality co-trimoxazole medicines that could compromise treatment of infectious diseases in children. This emphasizes the need for regular quality assurance tests to ensure only quality medicines are in the market.


Assuntos
Suspensões/química , Combinação Trimetoprima e Sulfametoxazol/análise , Cromatografia Líquida de Alta Pressão/normas , Rotulagem de Medicamentos/normas , Embalagem de Medicamentos/normas , Concentração de Íons de Hidrogênio , Quênia , Controle de Qualidade , Padrões de Referência , Combinação Trimetoprima e Sulfametoxazol/normas
2.
Clin Pharmacol Ther ; 110(3): 563-572, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34216021

RESUMO

Clinical annotations are one of the most popular resources available on the Pharmacogenomics Knowledgebase (PharmGKB). Each clinical annotation summarizes the association between variant-drug pairs, shows relevant findings from the curated literature, and is assigned a level of evidence (LOE) to indicate the strength of support for that association. Evidence from the pharmacogenomic literature is curated into PharmGKB as variant annotations, which can be used to create new clinical annotations or added to existing clinical annotations. This means that the same clinical annotation can be worked on by multiple curators over time. As more evidence is curated into PharmGKB, the task of maintaining consistency when assessing all the available evidence and assigning an LOE becomes increasingly difficult. To remedy this, a scoring system has been developed to automate LOE assignment to clinical annotations. Variant annotations are scored according to certain attributes, including study size, reported P value, and whether the variant annotation supports or fails to find an association. Clinical guidelines or US Food and Drug Administration (FDA)-approved drug labels which give variant-specific prescribing guidance are also scored. The scores of all annotations attached to a clinical annotation are summed together to give a total score for the clinical annotation, which is used to calculate an LOE. Overall, the system increases transparency, consistency, and reproducibility in LOE assignment to clinical annotations. In combination with increased standardization of how clinical annotations are written, use of this scoring system helps to ensure that PharmGKB clinical annotations continue to be a robust source of pharmacogenomic information.


Assuntos
Farmacogenética/normas , Medicina de Precisão/normas , Bases de Dados Genéticas/normas , Rotulagem de Medicamentos/normas , Prescrições de Medicamentos/normas , Humanos , Bases de Conhecimento , Medicamentos sob Prescrição/normas , Reprodutibilidade dos Testes
6.
PLoS One ; 16(5): e0250238, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34010291

RESUMO

INTRODUCTION: Correct interpretation of drug labels instructions (DLIs) is needed for safe use and better adherence to prescribed drugs. DLIs are often too difficult for patients, especially for those with limited health literacy. What is yet unknown, is how specific textual elements in DLIs (e.g., the presentation of numbers, or use of medical jargon) and patients' health literacy skills are related to the comprehension of DLIs. In order to provide concrete directions for health professionals on how to optimize drug prescriptions, we performed a systematic review to summarize the available research findings on which textual elements facilitate or hinder the correct interpretation of DLIs in relation to patients' health literacy. METHOD: A systematic search was performed in PubMed, EMBASE, PsychINFO, and Smartcat (until April 2019) to identify studies investigating textual elements that facilitate or hinder the correct interpretation of DLIs in relation to patients' health literacy. RESULTS: A total of 434 studies were identified of which 28 studies met our inclusion criteria. We found that textual elements contributing to the correct interpretation of DLIs were: using explicit time periods in dosage instructions, using plain language, presenting numbers in a numerical format, and providing DLIs in patients' native language. Multistep instructions per instruction line, using abbreviations and medical jargon seem to hinder the correct interpretation of DLIs. Although health literacy was taken into account in a majority of the studies, none of them assessed the effectiveness of specific textual elements on patients' comprehensibility of DLIs. CONCLUSION: Based on our findings, we provide an overview of textual elements that contribute to the correct interpretation of DLIs. Optimizing the textual instruction on drug labels may increase the safety and adherence to prescribed drugs, taking into account that a significant proportion of patients has low health literacy.


Assuntos
Rotulagem de Medicamentos/normas , Letramento em Saúde , Escrita Médica/normas , Compreensão , Humanos
7.
Am J Nurs ; 121(5): 25, 2021 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-33872259

RESUMO

The labeling for vinca alkaloid chemotherapy drugs is being revised to remove instructions for their administration with use of a syringe. This revision is in response to inadvertent intrathecal administration of vinca alkaloids, which is normally fatal.


Assuntos
Antineoplásicos/administração & dosagem , Rotulagem de Medicamentos/normas , Alcaloides de Vinca/administração & dosagem , Sistemas de Liberação de Medicamentos , Humanos , Neoplasias/tratamento farmacológico , Estados Unidos , United States Food and Drug Administration
8.
J Child Adolesc Psychopharmacol ; 31(4): 294-309, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33601936

RESUMO

Objectives: To determine the differences in information between prescribing guidelines and drug labeling, as well as to compare the approval of psychotropic medicines for major depression in pediatric patients ("pediatric depression") across countries. Methods: The recommendations of The Maudsley Prescribing Guidelines in Psychiatry (MPGP) for the treatment of pediatric depression (<18 years) were compared against the regulatory-approved drug-labeling documents from the United Kingdom, Australia, New Zealand, Canada, and the United States. The use of medicines outside of their regulatory approval is defined as off-label use, so differences between the drug labeling and MPGP were characterized according to unapproved age, indication, dosage, or route of administration. Information in the drug labeling was also compared across countries. Results: MPGP provides recommendations for 6 medicines for the treatment of pediatric depression, for which, 30 drug labeling were retrieved. Three of 30 drug labeling were consistent with MPGP recommendations (fluoxetine in the United Kingdom, fluoxetine and escitalopram in the United States). Differences in information between MPGP and the drug labeling were identified in 26 of 30 drug labeling analyzed, most often due to age (24/26) followed by indication (2/26). No differences pertaining to dosage or route of administration information were identified. The number of approved psychotropic medicines varied across the studied countries and we found cross-country discrepancies in information in the drug labeling. Conclusion: Significant differences in information exists between MPGP and the drug labeling for psychotropic medicines for pediatric depression, due to unapproved ages or indications. Additionally, approval information in the drug labeling are not consistent across countries. Further research into reasons for variability and impact on practice may be warranted.


Assuntos
Depressão/tratamento farmacológico , Aprovação de Drogas , Rotulagem de Medicamentos/normas , Guias como Assunto , Internacionalidade , Uso Off-Label , Psicotrópicos/uso terapêutico , Fatores Etários , Austrália , Criança , Humanos , América do Norte , Padrões de Prática Médica , Reino Unido
10.
Clin Pharmacol Ther ; 109(1): 65-72, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32453862

RESUMO

Most drug labels do not contain dosing recommendations for a significant portion of real-world patients for whom the drug is prescribed. Current label recommendations predominately reflect the population studied in pivotal trials that typically exclude patients who are very young or old, emaciated or morbidly obese, pregnant, or have multiple characteristics likely to influence dosing. As a result, physicians may need to guess the correct dose and regimen for these patients. It is now feasible to provide dose and regimen recommendations for these patients by integrating available scientific knowledge and by utilizing or modifying current regulatory agency-industry practices. The purpose of this commentary is to explore several factors that should be considered in creating a process that will provide more effective, safe, and timely drug dosing recommendations for most, if not all, patients. These factors include the availability of real-world data, development of predictive models, experience with the US Food and Drug Administration (FDA)'s pediatric exclusivity program, development of clinical decision software, funding mechanisms like the Prescription Drug Users Fee Act (PDUFA), and harmonization of global regulatory policies. From an examination of these factors, we recommend a relatively simple, efficient expansion of current practices designed to predict, confirm, and continuously improve drug dosing for more patients. We believe implementing these recommendations will benefit patients, payers, industry, and regulatory agencies.


Assuntos
Preparações Farmacêuticas/administração & dosagem , Preparações Farmacêuticas/normas , Relação Dose-Resposta a Droga , Cálculos da Dosagem de Medicamento , Rotulagem de Medicamentos/normas , Humanos , Estados Unidos , United States Food and Drug Administration/normas
11.
Eur J Clin Pharmacol ; 77(2): 251-260, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32989529

RESUMO

PURPOSE: Medicines regulatory authorities advise that patient information leaflets (PILs) should provide specific advice on what actions to take if one or more doses are missed. We aimed to assess the content in this regard, of PILs and Summaries of Product Characteristics (SmPCs) of prescription only medicines (POMs) marketed in the UK. METHODS: PILs and SmPCs were accessed via the electronic Medicines Compendium. The following terms were used in the advanced search facility: miss(ed), omit(ted), adhere(d), delay(ed), forgot, forget, lapse. Identified documents were screened for instructions on missed doses which were categorised according to level of specificity, and cross-referenced to the National Patient Safety Agency (NPSA) grading of risk of harm from omitted and delayed medicines. Any supporting clinical or pharmacological evidence was identified from SmPCs. RESULTS: Two thousand two hundred eighty-four documents were identified from 7248 PILs and SmPCs relating to 1501 POMs. Seven hundred eighty-three (52%) POMs had SmPCs or PILs with no instructions on missed doses; 487 POMs (32%) included non-specific advice (e.g. "take as soon as possible"); 138 (9%) provided specific instructions; and 93 (6%) referred patients to seek medical advice. SmPCs for only 13/138 (9%) of those which included specific instructions provided any supporting clinical or pharmacological evidence. Instructions were absent for several medicines where the NPSA assessed that dose omissions may result in significant risk of harm. CONCLUSIONS: Advice on missed doses is generally inadequate. Pharmaceutical companies and regulatory authorities should produce clear and concise instructions on what patients should do if they miss doses, with supporting evidence where necessary.


Assuntos
Rotulagem de Medicamentos/estatística & dados numéricos , Adesão à Medicação , Medicamentos sob Prescrição/administração & dosagem , Esquema de Medicação , Rotulagem de Medicamentos/normas , Humanos , Medicamentos sob Prescrição/normas , Reino Unido
12.
Ann Pharmacother ; 55(4): 459-465, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-32885981

RESUMO

BACKGROUND: Drug information resources are commonly used by health-care providers answering pregnancy-related medication questions. In 2015, the United States Food and Drug Administration approved a new pregnancy and lactation medication labeling content and format, removing the pregnancy category, and using a narrative. Despite labeling requirements changing, it is unknown if drug information resources updated monographs to reflect these changes. OBJECTIVE: The primary objective was to evaluate if commonly used drug information resources provide pregnancy information listed similar to the requirements of the Pregnancy and Lactation Labeling Rule (PLLR). Secondary analyses included evaluating the references and inclusion of the pregnancy category rating. METHODS: Pregnancy recommendations for 23 medications were evaluated in 9 drug information resources (Clinical Pharmacology, Drugs in Pregnancy and Lactation, Epocrates®, First Databank, LexiComp® Online, LexiComp® Online Pregnancy & Lactation, In-Depth, Medi-Span®, Micromedex®, and Multum®). The number of references per drug monograph and most recent reference publication year was obtained. RESULTS: LexiComp® Online Pregnancy & Lactation, In-Depth mimics the new PLLR structure and consistently had the highest number of and most recent references when the medication was included. Drugs in Pregnancy and Lactation was the next most similar in content with the PLLR and second in most references per monograph; however, the most recent reference was the textbook publication year. CONCLUSION AND RELEVANCE: LexiComp® Online Pregnancy & Lactation, In-Depth and Drugs in Pregnancy and Lactation provided pregnancy information in a format most similar to the PLLR. However, several drug information resources contained pregnancy categories ratings that were to be removed from medication labeling per the PLLR.


Assuntos
Rotulagem de Medicamentos/normas , Lactação/efeitos dos fármacos , Preparações Farmacêuticas/normas , Gravidez/efeitos dos fármacos , United States Food and Drug Administration/normas , Animais , Aleitamento Materno/tendências , Rotulagem de Medicamentos/tendências , Feminino , Humanos , Lactação/fisiologia , Gravidez/fisiologia , Estados Unidos/epidemiologia , United States Food and Drug Administration/tendências
13.
J Healthc Qual ; 43(1): 39-47, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-32544140

RESUMO

BACKGROUND: Recording vaccine data accurately can be problematic in medical documentation, including blank and inaccurate records. Vaccine two-dimensional (2D) barcode scanning has shown promise, yet scanner use to record vaccine data is limited. We sought to identify strategies to improve scanning rates and assess changes in accuracy. METHODS: Between January and June 2017, 27 pilot sites within a large health system were assigned to one of four groups to test strategies to maximize scanner use: training only, commitment card, scanning report, or combination. Seventy-two thousand vaccine records were assessed for completeness, accuracy, and scanning. RESULTS: Significant increases in vaccinator scanning rates found with commitment card and scanning report inclusion (alone and paired) compared with the training-only group. Record completeness and accuracy significantly improved with use of scanning. When manually entered, about 1 in 9 records had a missing or inaccurate expiration date; when scanned, this dropped to 1 in 5,000. CONCLUSIONS: Pilot findings indicate 2D scanning has the potential to eliminate most omissions and inaccuracies in vaccine records. Such data are critical during a recall or need to trace specific vaccines or patients. IMPLICATIONS: Consistent use and expanded adoption of 2D scanning can meaningfully improve the quality of vaccine records and clinical practices.


Assuntos
Confiabilidade dos Dados , Documentação/normas , Rotulagem de Medicamentos/normas , Processamento Eletrônico de Dados/normas , Registros Eletrônicos de Saúde/normas , Vacinação/normas , Vacinas , Humanos , Projetos Piloto , Estados Unidos
14.
J Diet Suppl ; 18(1): 44-56, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-31809613

RESUMO

The objective of this study was to analyze labeling practices and compliance with regulatory standards for shark cartilage supplements sold in the United States. The product labels of 29 commercial shark cartilage supplements were assessed for compliance with U.S. regulations. Claims, including nutrient content, prohibited disease, and nutritional support statements, were examined for compliance and substantiation. Overall, 48.3% of the samples had at least one instance of noncompliance with labeling regulations. The most common labeling violations observed were: missing a domestic address/phone number, non-compliant nutrient content claim, missing/incomplete disclaimer, missing statement of identity, prohibited disease claims, and incomplete "Supplement Facts" label. The use of prohibited disease claims and nutritional support statements without the required disclaimer is concerning from a public health standpoint because consumers may delay seeking professional treatment for a disease. The results of this study indicate a need for improved labeling compliance among shark cartilage supplements.


Assuntos
Cartilagem , Suplementos Nutricionais , Rotulagem de Medicamentos/legislação & jurisprudência , Tubarões , United States Food and Drug Administration/legislação & jurisprudência , Animais , Suplementos Nutricionais/normas , Rotulagem de Medicamentos/normas , Regulamentação Governamental , Fidelidade a Diretrizes/legislação & jurisprudência , Estados Unidos
16.
J Clin Pharmacol ; 60 Suppl 2: S18-S25, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33274508

RESUMO

Pregnant women have historically been an understudied population and have been excluded from clinical trials. Recent efforts by stakeholders have raised awareness of the importance of clinical research in pregnant women to inform prescribing decisions. The Food and Drug Administration continues working to improve the format and content of prescription drug labeling for pregnant and lactating women, as demonstrated with the Pregnancy and Lactation Labeling Rule (PLLR), effective in 2015. The pregnancy labeling subsection now includes a subheading dedicated to the inclusion of pharmacokinetic (PK) data that inform the need for dose adjustments during pregnancy and the postpartum period. In addition, the PLLR also requires prescription drug labeling to be updated when important pregnancy information becomes available. Although PLLR improved the presentation of pregnancy-related information in labeling, there is a need to increase the quality and quantity of human data on the use of prescription drugs during pregnancy. PK studies in pregnant women should be incorporated into drug development programs and prioritized to obtain important information about safe and appropriate doses of a drug when used during pregnancy. In addition, opportunistic PK studies, postapproval pregnancy safety studies, ex vivo studies, and in silico modeling can be leveraged to better inform the risks and benefits of using a drug during pregnancy to inform study design and to further understand various mechanisms impacting pharmacokinetic/pharmacodynamic of drugs during pregnancy. It is important to address the significant existing data gaps and better inform the safety and dosing of prescription drugs for pregnant women.


Assuntos
Rotulagem de Medicamentos/normas , Medicamentos sob Prescrição/efeitos adversos , Animais , Aleitamento Materno , Rotulagem de Medicamentos/tendências , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Feminino , Humanos , Lactação , Camundongos , Segurança do Paciente , Período Pós-Parto , Gravidez , Gestantes , Medicamentos sob Prescrição/farmacocinética , Coelhos , Estados Unidos , United States Food and Drug Administration
18.
Vaccine ; 38(52): 8318-8325, 2020 12 14.
Artigo em Inglês | MEDLINE | ID: mdl-33199075

RESUMO

The counterfeiting of vaccines is an increasing problem globally with the safety of persons vaccinated, the trust in vaccines generally and the associated reputation of vaccine manufacturers and regulatory agencies at risk. This risk is especially critical with the on-going development of COVID-19 vaccines. The ability to track and trace vaccines through the vaccine supply chain down to persons vaccinated has to be enhanced. In this context of traceability, the global immunization community has recently set the barcoding of the primary packaging of vaccines, specifically vaccine vials and pre-filled syringes, as a top priority. Emerging vaccine manufacturers are already engaged in investigating ways to incorporate barcoding in their labelling and packaging using GS1 international standards. A specific pilot taking place in Indonesia by the national vaccine manufacturer, Bio Farma, shows the innovation of barcoding on primary packaging already underway with a relatively modest level of investment and success at this stage. This article highlights the efforts of industry and governments on the value of traceability and introduction to 2D barcodes. Access to financial resources and support from the international immunization community would accelerate such innovations leading to enhanced security of the vaccine supply chain.


Assuntos
Medicamentos Falsificados , Indústria Farmacêutica/normas , Rotulagem de Medicamentos/normas , Processamento Eletrônico de Dados , Vacinas/normas , Vacinas contra COVID-19/normas , Indústria Farmacêutica/economia , Indústria Farmacêutica/métodos , Rotulagem de Medicamentos/métodos , Humanos , Indonésia , Cooperação Internacional , Invenções , Investimentos em Saúde , Inovação Organizacional , Projetos Piloto
19.
JAMA Netw Open ; 3(8): e2015094, 2020 08 03.
Artigo em Inglês | MEDLINE | ID: mdl-32865574

RESUMO

Importance: The US Food and Drug Administration (FDA) Pregnancy and Lactation Labeling Rule (PLLR), implemented in 2015, includes information on pregnancy, lactation, and women and men with reproductive potential. Objectives: To identify the drugs that have adhered to the new PLLR format; to shed light on the continued need for implementation of pregnancy, lactation, and reproduction into clinical studies; and to evaluate how many new therapeutic products have human and animal data specific to pregnancy and lactation. Design, Setting, and Participants: This cross-sectional study of 290 new therapeutic drugs reviewed labeling data for newly FDA-approved therapeutic products from January 2010 to December 2019. Therapeutic products submitted on or after June 30, 2015, were required to be in PLLR format; those approved from June 30, 2007, to June 29, 2015, had until June 30, 2019, to be in PLLR format. Approval data and subsequent labeling revision were evaluated for pregnancy and lactation data (human and animal), pregnancy registry, black-box warnings, and inclusion of PLLR labeling format. Exposures: Date of new drug approval by FDA. Main Outcomes and Measures: Compliance with PLLR; presence of animal or human data; presence of pregnancy registries; and presence of information regarding female and male reproductive potential. Results: A total of 290 new molecular entities or therapeutic products were approved by the FDA between 2010 and 2019 in 19 categories. Black-box warnings occurred in 89 drugs (30.7%; 95% CI, 25.4%-36.3%), with 3 (3.4%; 95% CI, 0.7%-9.5%) involving pregnancy. All products submitted after June 30, 2015, were in PLLR format; however, of the 138 submitted between 2010 and that date, 45 (32.6%; 95% CI, 24.9%-41.1%) were not in PLLR format by June 30, 2019. During the 10 years of data analyzed, significantly more were in PLLR format (P for trend < .001). Most approved therapeutic products have pregnancy data derived from animal studies (260 products; 89.7%; 95% CI, 85.6%-92.9%) but only 31 (10.7%; 95% CI, 7.4%-14.8%) derived data from human studies. Only 148 therapeutic products (51.0%; 95% CI, 45.1%-56.9%) had any data associated with lactation, 143 (49.3%; 95% CI, 43.4%-55.2%) originating from animal studies and 8 (2.8%; 95% CI, 1.2%-5.4%) from human studies. Conclusions and Relevance: The results of this study show that with the implementation of PLLR in the last decade, new therapeutic products were in compliance with the new rules; however, more than one-third of labels remain out of PLLR compliance. Human data on pregnancy and lactation are available in less than 20% of new product labeling.


Assuntos
Rotulagem de Medicamentos/legislação & jurisprudência , Rotulagem de Medicamentos/normas , Lactação/fisiologia , Gravidez/fisiologia , Animais , Aleitamento Materno , Estudos Transversais , Aprovação de Drogas , Feminino , Fidelidade a Diretrizes , Humanos , Segurança do Paciente
20.
CPT Pharmacometrics Syst Pharmacol ; 9(11): 639-648, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32945631

RESUMO

Elagolix is a novel oral gonadotropin releasing hormone receptor antagonist, that can suppress estradiol in a dose-dependent manner. It is indicated for management of moderate-to-severe pain associated with endometriosis. A population exposure-response model describing the relationship between elagolix exposure and changes in bone mineral density (BMD) was developed using data from four phase III studies in premenopausal women with endometriosis-associated pain. Elagolix pharmacokinetic exposure-dependent changes in BMD were described by an indirect-response maximum effect (Emax ) model through stimulation of bone resorption. African American race, higher body mass index (BMI), and lower type-I collagen C-telopeptide concentrations were significantly associated with higher baseline BMD. Higher BMI was significantly associated with higher bone formation rates. Simulations using the final model demonstrated that elagolix 150 mg q.d. dosing for 24 months is predicted to result in -1.45% (-2.04 to -0.814) decrease from baseline in BMD and were used to support corresponding dosing recommendations in the label.


Assuntos
Densidade Óssea/efeitos dos fármacos , Hidrocarbonetos Fluorados/efeitos adversos , Hidrocarbonetos Fluorados/farmacocinética , Dor/tratamento farmacológico , Pirimidinas/efeitos adversos , Pirimidinas/farmacocinética , Receptores LHRH/antagonistas & inibidores , Absorciometria de Fóton/métodos , Administração Oral , Adulto , Afro-Americanos/etnologia , Variação Biológica da População , Índice de Massa Corporal , Estudos de Casos e Controles , Colágeno Tipo I/análise , Simulação por Computador , Rotulagem de Medicamentos/normas , Endometriose/complicações , Feminino , Humanos , Hidrocarbonetos Fluorados/administração & dosagem , Hidrocarbonetos Fluorados/uso terapêutico , Pessoa de Meia-Idade , Dor/etiologia , Peptídeos/análise , Valor Preditivo dos Testes , Pirimidinas/administração & dosagem , Pirimidinas/uso terapêutico , Segurança
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