Pharmacovigilance and Pharmacoepidemiology
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Published By Edelweiss Publications Inc

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Author(s):  
Famuyiwa Toluleke Oloruntobi ◽  
Bowers Zoey ◽  
Bentley Austin ◽  
Caraballo Davian ◽  
Subtil Paulynice ◽  
...  

A major problem associated with prostate cancer treatment is the development of drug resistance. The development of drug resistance often leads to prostate cancer metastasis and prostate cancer-targeted drug delivery systems can be utilized to address this problem. Traditional drug delivery systems have many challenges, including the inability to control the drug release rate, target site inaccuracy, susceptibility to the microenvironment, poor drug solubility, and cytotoxicity of chemotherapeutics to non-malignant cells. As a result, there is an urgent need to formulate and functionalize a drug delivery system that better controls drug release. This study was designed to quantify the release of SC-514 from SC-514 Polylactic-Co-Glycolic Acid (PLGA) nanoparticles and conjugate SC-514-PLGA coated nanoparticles with the NF- κβ antibody, as well as fats. This study further explored new methods to quantify the release of SC-514 drug from the SC-514-PLGA coated nanoparticles after utilizing Liquid Chromatography–Mass Spectrometry (LC-MS) as the standard method to quantify SC-514 drug released. After quantification was completed, cell viability studies indicated that the ligand conjugated nanoparticles demonstrated a considerable ability to reduce tumor growth and SC-514 drug toxicity in the PC-3 cell line. The prepared drug delivery systems also possessed a significantly lower toxicity (P<0.05), bettered controlled-release behaviors in prostate cancer, and increased the solubility of SC-514 in comparison to free SC-514. SC-514 released from SC-514-PLGA, SC-514-PLGA-NF- κβAb, and SC-514-PLGA-Fat nanoparticles, significantly inhibited tumor growth when compared to that of free SC-514. The anti-cancer therapeutic effects of SC-514 were improved through the encapsulation of SC-514 with a PLGA polymer. The functionalized SC-514-PLGA nanoparticles can further control burst release. The new methods utilized in this study for quantifying drug release, may prove to be as effective as the current standard methods, such as LC/MS.


Author(s):  
Ampadu Clement Boateng

In they introduced the Chen distribution, and in they extended the distribution to include its “normalized version”. In this paper, we introduce a variant of the Gull Alpha Power distribution by modifying Chen-G of and show the new family is good in fitting real life data.


Author(s):  
Megna James ◽  
David Lehmann ◽  
Vishal Anugu ◽  
Maggie Lynch

Risk-benefit analysis and management is a core responsibility of physicians during the process of formulating and implementing a comprehensive and effective treatment plan. This assumes particular importance when working with individuals diagnosed with schizophrenia who are confronted with a 5% lifetime risk of completed suicide, as well as the risk of Torsades de Pointes (TdP), a lethal tachydysrhytmia, as a result of antipsychotic medication management. However, the actual risk of such an event, based upon recent epidemiologic data, is less than one-sixth that of completed suicide. Consequently, due consideration must be given to these data while constructing the medication component of a biopsychosocial treatment plan, as avoidance or under-prescribing of antipsychotics places an individual with schizophrenia at greater risk of completed suicide than that of TdP.


Author(s):  
Despoina G Alamanou ◽  
Konstantinos Giakoumidakis ◽  
Dimosthenis G Theodosiadis ◽  
Nikolaos V Fotos ◽  
Elissavet Patiraki ◽  
...  

Objective: In Greece, the old phenomenon of hiding cancer diagnosis and depriving cancer patients of their right to participate in decisionmaking remains a reality. The aim of this study was to assess the decision-making preferences of Greek cancer patients and their awareness of diagnosis. Methods: It was a cross-sectional study. The sample consisted of 229 adult Greek patients diagnosed with cancer, attending the oncology outpatient department (outpatients) or being hospitalized (inpatients), in one general hospital in Athens. Patients who were aware of cancer diagnosis (n=209) were administered at the Control Preference Scale (CPS), a tool, designed to elicit decision-making preferences. The IBM SPSS program, version 21.0 was used for statistical analysis. Results: One hundred and one patients (52.8%) were males. The mean [±standard deviation (SD)] age was 64.8 (±11.2) years. The vast majority of patients knew they suffered from cancer (n=209, 91.3%). Older patients (p=0.003), those who lived in suburbs of the city (p=0.01), those who had lower educational level (p=0.001), those with lower personal income (p=0.001) and shorter disease duration (p=0.001) stated that were unaware of cancer diagnosis. Seventy five (36.2%) patients chose the shared-decision role in decision-making procedures. Lower age (OR 1.04, 95%, CI: 1.00-1.08, p= 0.05) and higher education level (OR 2, 63, 95%, CI: 1.11-6.29, p=0.03) were significantly associated with the preference of patients to actively participate in decision-making regarding treatment. Conclusions: Although Greek cancer patients are aware of cancer diagnosis and treatment, nowadays, they still seem to hesitate in playing a more active role in the decision-making procedures, which portrays the impact of the dominating paternalistic model of doctor-patient relationship in the Greek medical encounter


Author(s):  
Elene Chikobava ◽  
Irma Beridze

The modern pharmaceutical industry is one of the main branches in the healthcare segment and is considered to be the most highly regulated industries worldwide. The regulation is provided by a specialist, named Regulatory Affairs Manager (syn.: Regulatory Affairs Executive or Regulatory Affairs Associate), involved in authorization process of pharmaceutical products. When person graduates from University with medical, pharmaceutical or even chemical diploma, he/she never thinks about professional career as a Regulatory Affairs Manager, because this specialty is new, about 40 years old. What is a Regulatory Affairs Associate’s duty? One category-Regulatory Affairs Associate inside the manufacturing office, whose duty is to prepare registration dossier based on the process of artworks and Patient Information Leaflet preparation, prior to completing Common Technical Document (CTD) format dossier; other category (national regulatory affairs Associate)-are those who are ensuring mediation between Manufacturer and Government Regulatory Authorities. Regardless of differences of each Government requirement for dossier registration, the main task of each Regulatory Affairs Associate is to prepare Dossier for submission which will pass successful registration. For this purpose, the National Regulatory Affairs Associate should ensure that manufacturer/Marketing Authorization Holder (MAH)’s dossier is complete and in line with different documentation requirements, following the national requirements and in case such requirement don’t exist-with the guidelines of the World Health Organization (WHO) and International Council for Harmonization (ICH). On the other hand, National Regulatory Affairs Associate is working with National Regulatory Affairs officers to correct and align deficiencies in documentation in accordance with the National requirements. Each drug as a living organism (innovative drugs even have birthdays), which is subject to many changes reflected in the registration dossier: whether in its pharmaceutical part (composition, production process, stability etc.,) or pharmacological (therapeutic indications, side effects and others), as a consequence the Regulatory Affairs Manager is constantly involved in registration of an infinite number of Variations. The main goal of Regulatory structures-both governmental and private-is to ensure the safety, quality and efficacy of medicines.


Author(s):  
Abdul Kader Mohiuddin

With the increasing burden of non-communicable diseases in Low-Income and Middle-Income Countries (LMICs), biological risk factors, such as hyperglycemia, are a major public health concern in Bangladesh. Optimization of diabetes management by positive lifestyle changes is urgently required for prevention of comorbidities and complications, which in turn will reduce the cost. Diabetes had 2 times more days of inpatient treatment, 1.3 times more outpatient visits, and nearly 10 times more medications than non-diabetes patients, as reported by British Medical Journal. And surprisingly, 80% of people with this so called Rich Man’s Disease live in low-and middle-income countries. According to a recent study of American Medical Association, China and India collectively are home of nearly 110 million diabetic patients. The prevalence of diabetes in this region is projected to increase by 71% by 2035. Bangladesh was ranked as the 8th highest diabetic populous country in the time period of 2010-2011. In Bangladesh, the estimated prevalence of diabetes among adults was 9.7% in 2011 and the number is projected to be 13.7 million by 2045. The cost of diabetes care is considerably high in Bangladesh, and it is primarily driven by the medicine and hospitalization costs. According to Bangladesh Bureau of Statistics, in 2017 the annual average cost per Type 2 Diabetes Mellitus (T2DM) was $864.7, which is 52% of per capita Gross Domestic Product (GDP) of Bangladesh and 9.8 times higher than the general health care cost. Medicine is the highest source of direct cost (around 85%) for patients without hospitalization. The private and public financing of diabetes treatment will be severely constrained in near future, representing a health threat for the Bangladeshi population.


Author(s):  
MC van Campen C(Linda)

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), is a chronic and often disabling disease. Although the exact pathophysiological mechanism of ME/CFS is unknown, immunological abnormalities may play an important role. Curcumin is an herb with powerful anti-oxidative and anti-inflammatory properties. Therefore, we hypothesized that curcumin would have favorable effects on symptomatology in ME/CFS patients. In an open trial among 65 ME/CFS participants, 6 stopped the use of curcumin because of side effects and 8 did not complete the end of study questionnaire. Before and 8 weeks after the use of curcumin complexed with phosphatidyl choline-, 500 mg bid, participants completed the CDC inventory for assessment of Chronic Fatigue Syndrome. The CDC questions (n=19) were scored and divided into 2 parts: the first being specific for CFS complaints (n=9), the second being scores of less specific symptoms (n=10); denoted as CDC other score. Results showed that 8 weeks of curcumin significantly decreased the CDC CFS-related symptom scores and CDC other scores, especially in patients with mild disease. Conclusion: in this open-labeled study 8 week curcumin use in a phosphatidyl choline complex reduced ME/CFS symptomatology, especially in patients with mild disease severity.


Author(s):  
Hailu Zeru ◽  
Aynalem Gemechu ◽  
Tenaw Andualem ◽  
Hayat Seid ◽  
Fikadu Mengesha

A cross-sectional study was conducted from January to March 2018 to assess the awareness of veterinary drug retail outlets on Antimicrobial Resistance (AMR) and the availability of veterinary antimicrobials in these facilities. Qualitative and quantitative data were collected using a structured questionnaire from a total of 108 retail outlets. The study revealed that there is a difficulty to treat infectious diseases of animals because of AMR which is reported by 70 (64.8%) of the respondents. 80.6% of the respondents believe that use of wrong antimicrobial is the possible cause of AMR and 79.6% use of counterfeit or poor quality antimicrobials, and 70.4% owners self-prescription of medicines for their animals. 59 (54.6%) of them also answered poor husbandry practices such as overcrowding, poor hygiene and sanitation, and poor feeding practice are the possible causes of AMR while 8 (7.4%) and 9 (8.3%) of the respondents do not know the reason for the AMR development and possible solutions for AMR containment, respectively. Only 24 (22.2%) of the dispensers have taken training on antimicrobial selection, use, resistance and resistance containment. Even though antimicrobials such as Oxytetracycline are available in around 90% of the retail outlets, only 70 (64.8%) of the retail outlets receive an average of 14 prescriptions (ranging from one to 200) per week from public and private clinics which shows a practice of antimicrobials dispensing without prescription. Therefore, strong mainstreaming strategies to prevent and control AMR should be developed and implemented. Antimicrobials prescription and dispensing practice should also be well regulated to avoid irrational prescription and dispensing practices.


Author(s):  
Ryan Francis ◽  
Perceval S Bahado-Singh ◽  
Andrew O Wheatley ◽  
Ann Marie Smith ◽  
Helen N Asemota

Background: Fruits, vegetables and legumes for their complex carbohydrates, dietary fiber and micronutrients, should form an essential part of every diet. In order to give good dietary advice to diabetic patients, it is necessary to know the glycemic index of foods commonly consumed locally. The objective of this study was to determine the Glycemic Index (GI) and Glycemic Load (GL) of commonly available and consumed Guava (Psidium guajava), Watermelon (Citrullus vulgaris), Gungo (Cajanus cajan), Papaya (Carica papaya) and tomato (Solanum lycopersicum) in Jamaica. Methods: Ten (10) healthy Jamaican subjects (5 males, 5 females) with mean age 30 ± 2 years and mean BMI 25 ± 1 kg/m2 were recruited to the study. Using a non-blind, crossover design trial, the subjects consumed 50 (or 25) grams of available carbohydrate portions of glucose (standard food) and test foods after an overnight fast and their serum glucose levels were determined at 0, 15, 30, 45, 60, 90 and 120 minutes after the consumption of each test food. Glucose was tested on three separate occasions, and the test foods once. The GI value was calculated geometrically by expressing the Incremental Area Under the Blood Glucose Curve (IAUC) for the test foods as a percentage of each subject's average IAUC for the standard food. Results: The results indicated that the IAUC for Watermelon (95 ± 11) was significantly higher (p<0.05) than that of Tomato (37 ± 12), and Gungo (58 ± 13). The differences in IAUC of Watermelon (95 ± 11), Guava (83 ± 27) and Papaya (80 ± 7) were not statistically significant. Similarly, there was no significant difference in GI among the samples studied. Conclusion: Tomato, Gungo, Papaya Watermelon and Guava were shown to have low glycemic index and glycemic load values.


Author(s):  
Rimsha Imam ◽  
Aqsa Saeed ◽  
Rana Khalid Iqbal

Stem cells have a great potential to divide and present in all multicellular organism throughout their life. It holds a wide range of applications in novel therapies for the cure of many diseases and injuries by using early embryonic cells as well as adult stem cells. In research, they provide the whole knowledge of how humans develop from a cell. Understanding the phenomena of stem cells we can use these cells for the specific purpose in treating diseases such as modeling disease, cell-based therapies or drug screening. Adult as well as embryonic stem cells collectively used to treat such problems for the benefits of society. The power of plasticity in adult stem cells has yet determined. Use of stem cells can carry various ethical impacts along with several applications.


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