Abstract:

Background: Accurate diagnosis and appropriate treatment of malaria with the recommended antimalarials are crucial in the fight against malaria. This study evaluated the availability and sources of ACT and RDT kits among the Over-The-Counter (OTC) medicine sellers in the Pru, Sene and Atebubu-Amantin Districts of Ghana.

Method: A cross-sectional descriptive study was conducted using a structured questionnaire. Sixty-two OTC medicine sellers were randomly selected, informed consent sought and interviewed on access to RDT kit, ACT and Training in malaria diagnosis. Data entry, editing and analysis was done using SPSS Ver 22.

Results: The study revealed that 26.2% of respondents use the RDT kits to diagnosis and confirm suspected malaria. 94.1% respondents who had malaria RDT kits at their shop purchased them from the NMCP and Pharmacy shops. 95% of respondents had in stock at least one of the 3 recommended ACT - artesunate amodiaquine, artemether lumefantrine, and/or dihydroartemisinin piperaquine.65.6% of respondents often recommend artemether lumefantrine to patients to treat uncomplicated malaria.. The average wholesale and retail prices of the Affordable Medicine Facility malaria (AMFm) branded ACT were higher than the approved suggested retail prices.

Conclusion: Most OTC medicine sellers do not comply with the national antimalarial drug treatment policy. 85% of OTC medicine sellers purchase their AMFm branded ACT from second-line buyers at relatively higher price.

Recommendation: Regular training of OTC medicine sellers on malaria control and easier access to quality and affordable malaria RDT kits and ACT would help improve malaria control at the community level.

Keywords: Malaria, ACT, RDT, OTC medicine seller, Pru, Sene and Atebubu-Amantin.

References:

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[7]. Danquah D.A ,Evaluating Access to Anti-Malaria medicine and quality of Service delivery by Community Pharmacies and Licensed Chemical Shops in Ashanti Region, Ghana 2010

[8]. FHI 360, OTC medicine sellers identification and selection exercise, Pru, Sene and Atebubu-Amantin districts, 2015, Ghana

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Abstract:

Biologics development represents a substantial advancement in the pharmaceutical industry because of their promise and huge success in the oncology, immunoscience, and cardiovascular disease areas. Prior to entering the marketed product development phase, each biopharmaceutical needs to go through series of stages that will allow or disallow the biologics asset to become a commercialized product. Each of those phases includes development planning and designing of studies to test relevant hypotheses to support the drug label if approved.

The current thesis will focus on the principles, assumptions, and processes that are established to designate an asset (biologics) as a targeted first-in-human program. First-in-human studies are included under phase 1 trials, where initial human exposure is initiated to the investigational new drug (IND). Phase 1 is critical since it affirms if a compound’s mechanisms of action in humans and its development can result in a potentially new drug entity.

Subsequently, step by step initiatives and processes from the perspective of different functional groups within the pharma will be revised to outline the staged procedures, methods, critical, and non-critical paths taken when a molecule is nominated as a clinical candidate. Overall alignment of deliverables will be presented between the different functional areas that partake in the first-in-human development.

Strategic changes to the biologics development process, cell line development with multiple candidate sequences, initial platform fit assessment for a process, analytical and formulation will be acknowledged. Platform strategy for drug substance production, as well as, drug product composition will be outlined along with boilerplates for analytical method development to fit or not fit the platform approach. The functional groups that will be reviewed will be; Discovery, Cell line development, Drug Substance process development, Formulation development, Toxicology, Quality, Drug Substance manufacturing, Drug Product manufacturing, Stability and regulatory.

Keywords: Fast to First in Human, Biologics, Development, Clinical.

References:

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Abstract:

Background: Anti-retroviral therapy was introduced in 1997 to manage people living with the Human Immune-deficiency virus (HIV). The success of treatment is dependent optimal levels of 95% or more adherence. A 2015 study conducted at the Rimuka Integrated HIV and TB Centre, revealed a sub-optimal adherence rate 0f 87% by self-report and 65% by pill counts. We set out to investigate the efficacy of cell phone short message service on adherence among clients on ART at the center.

Methodology: KAMPS was a parallel design randomized controlled trial of HIV clients receiving ART at Kadoma (Zimbabwe). Respondents were randomised 1:1. Respondents in the intervention group received a weekly motivational SMS in addition to standard HIV care whilst those in the non-intervention arm received standard care alone. The primary outcome was adherence measured using a composite scale. Secondary outcomes were weight, CD4+; and, viral load, measured at baseline and 26 weeks. The primary analysis was by intention to treat. The trial was registered PACT20161001858240.

Results: Of the 552 assessed respondents, 470 were eligible and were randomized into the study. However, analysis was done for 449 respondents. At 26 weeks, 180 (76.9%) respondents in the intervention group were considered adherent compared to 127(59%) in the non-intervention group (p=0.65). The mean CD4+ cell count at six months was 554 cells mm^-3 among those in the non-intervention group compared to 619 cells per mm^-3 among those in the intervention group. Mean viral load was 392 copies ml^-1 of blood in the intervention group compared to 2859 copies ml^-1 in the non-intervention arm. Among those in the intervention group 140(60%) had viral suppression compared to 93 (43%) in the non-intervention arm.

Conclusion: We conclude that weekly motivational short message influenced adherence and ultimately CD4+ cell count, viral loads and viral suppression.

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Abstract:

The Food and Drug Administration (FDA) is a federal agency of the United States that is responsible for protecting the health of the public by ensuring the security, efficacy, and safety of both the veterinary and human drugs. The agency is also responsible for ensuring the safety of the food supply, radioactive materials, and cosmetics in the United States. The FDA has a statutory duty of ensuring that manufacturers of various products, including pharmaceuticals, comply with their respective established Good Manufacturer Practice (GMP).

ELISA (enzyme-linked Immunosorbent analysis) is an important bioanalytical assay format that pharmaceutical companies particularly use to validate in order to achieve a robust method suitable for the purpose of development of drugs and biologics in FDA regulated environment.

The analytical laboratories carrying out all toxicology or pharmacology as well as other pre-clinical studies for the purposes of making regulatory submissions are expected to comply with FDA’s Good Laboratory Practices (GLPs) and sound quality assurance principles throughout the validation of appropriate ELISA methods and/or testing process. As long as pharmaceutical companies evaluate analytical methods before and during regular use, they are not under any statutory obligation to comply with the FDA guidelines on method validation, including bioanalytical methods such as ELISA methods.

Keywords: FDA, GxP, Impurity ELISA, sandwich ELISA, validation. Basic Principles and Applied GxP Regulations for ELISA Analytical Method Validation of Drugs and Biologics in FDA Driven Environment.

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Abstract:

The objective of the study is to evaluate the effect of labour strikes patient satisfaction in secondary Health Institutions in Cross River State, Nigeria. The study is cross-sectional descriptive study of 508 respondents form outpatient department, laboratory department, pharmacy department, Ante-Natal and Post-Natal clinic and ART clinic at the 7 secondary health institutions in CRS spread across 3 senatorial districts in the state between January and February 2018 using semi structured; self-administered, closed- and open-ended questionnaires that were divided into different sections each. Raw data were entered EpiData™ and exported for analysis using the SPSS software version 20. The data were cleaned and validated for use. Frequency tables were produced and associations between categorical variables were determined using chi squared test at a significance level of P<0.05.

Meanwhile, the negative effects of strikes are generally highly felt among all patients with no statistical significant difference whether employed, unemployed or retired (P>0.05). One of the effects of health workers’ strike is that strikes increase death rates and the result showed that regardless of patient’s education level, patients are fully aware that one of the effects of frequent strikes is increase in death rate (P>0.05). The result indicates that there is statistical significant difference in respondents’ responses between those without formal education, non-graduates and graduates. i.e. the higher the level of education, the higher the awareness that labour strikes affect the duty of health workers and have effect on patient’s attendance, poor healthcare performance and cause patients’ dissatisfaction (P<0.05).

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Abstract:

Introduction: Globally every day, about 830 women die due to complications of pregnancy and child birth. Of these deaths, 99% occur in low-resource settings, and most could be prevented. Use of Modified Early Obstetric Warning System (MEOWS) would be appropriate. MEOWS is a monitoring chart intended to identify mothers at risk and initiate the right action, at right time by the appropriately skilled clinicians, at a time when treatment might make a difference to reduce maternal mortality and morbidity.

Objectives: To determine the sensitivity, specificity and predictive values of Modified Early Obstetric Warning System (MEOWS) in correctly identifying women at risk of developing obstetric morbidity in St. Francis Hospital_Nsambya between January and February, 2016

Methods: The study was a prospective cohort study conducted at St. Francis Hospital Nsambya, maternity ward, from January to February 2016. MEOWS monitoring tool was used alongside with questionnaires.

Result: 502 respondent mothers were enrolled in the study. 160patients (31.9%) triggered and of which: 11.5% of them had obstetric morbidity which included postpartum haemorrhage-35.5%, preeclampsia-26.3%, suspected infection-22.4%, third degree perineum tear-5.3%, anaesthetic complications-4% and prolong hospital stay-7%. MEOWS was 81.7% sensitive (95% CI 80-94%), 76.3% specific (95% CI 74-81%), with a positive predictive value 36.3% (95% CI 31-44%) and negative predictive value of 96.2% (95% CI 94-99%).

Conclusion: MEOWS chart is even effective for use in low resource setting, like Uganda.

Keywords: Modified Early Obstetric Warning System (MEOWS). Sensitivity. Validity. Predictive values. Maternal Morbidity. Maternal Mortality.

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Abstract:

The focus of this research is to evaluate the method validation processes in ELISA (enzyme-linked Immunosorbent assay), particularly in the development of drugs and biologics and subsequent method validations following strictly regulated rules in GxP controlled environment.

In an effort to bolster the existing formal system of controls at pharmaceutical companies through the CGMP regulations, the Food and Drug Administration (2011) has established general principles and practices for the validation process. These general principles and practices are suitable elements that pharmaceutical companies should use in process validation for the manufacture of animal and human biological and drug products, including the active pharmaceutical ingredients (APIs).

Keywords: ELISA, validation, GxP, FDA, critical reagents, regulations.

References:

The focus of this research is to evaluate the method validation processes in ELISA (enzyme-linked Immunosorbent assay), particularly in the development of drugs and biologics and subsequent method validations following strictly regulated rules in GxP controlled environment.

In an effort to bolster the existing formal system of controls at pharmaceutical companies through the CGMP regulations, the Food and Drug Administration (2011) has established general principles and practices for the validation process. These general principles and practices are suitable elements that pharmaceutical companies should use in process validation for the manufacture of animal and human biological and drug products, including the active pharmaceutical ingredients (APIs).

Keywords: ELISA, validation, GxP, FDA, critical reagents, regulations.

Abstract:

Biologics development represents a substantial advancement in the pharmaceutical industry because of their promise and huge success in the oncology, immunoscience, and cardiovascular disease areas. Prior to entering the marketed product development phase, each biopharmaceutical needs to go through series of stages that will allow or disallow the biologics asset to become a commercialized product. Each of those phases includes development planning and designing of studies to test relevant hypotheses to support the drug label if approved.

In this study, the findings from the survey that was conducted previously as planned. It is organized into various sections, which include a summary of the study approach, the original research questions and hypotheses, the actual number of interviewed participants and response rate, and the general quantitative results of the survey in terms of gender, age, department, and experience. The chapter then presents qualitative results from content analysis and then finally, an in-depth discussion of the implication of these findings.

Keywords: Fast to First in Human, Biologics, study approach, survey.

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