Pharmacokinetic and pharmacodynamic studies

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Reference no: EM132901983

Introduction
Proposals are the essential first step to any research study. This research proposal will be viewed by various groups and committees for their approval. You must have approval and funding to perform a study! A research proposal can often take months to construct in the real world. The research proposal is submitted as a Letter of Intent. In this module, you will practice this process by writing a proposal using existing studies as ideas, and then summarizing how the studies were relevant by completing a Literature Review.

Directions
1. Read the Learning Units and textbook chapters and watch the video to prepare yourself for the assignment.
2. Review the Research Requests for Proposals (RFP) from the National Institutes of Health, listed below.
3. Select one RFP for your assignment, to complete a Research Proposal/Letter of Intent.
4. Use the Letter of Intent template downloadto complete your Research Proposal/Letter of Intent for your selected RFP.
5. For your Research Proposal/Letter of Intent, use the FSCJ Library and Learning Commons (must come from the library-not the web) and complete a literature review that is relevant to the proposal.
6. Use PICO to input your Literature Review on the Research Proposal/Letter of Intent.
Format
1. Use the Letter of Intent Template download. You must include:
a. Principal Investigator
b. Affiliation/Institution
c. Name of Study
d. Abstract (250 words)
e. Proposal (1 to 2 pages without references)
f. Literature (1 to 2 pages without references)
g. References in APA format. (Minimum of 3 references)
2. Proposal documentation should be in Arial, 10-point font, double spaced
3. Do your resources meet the CRAAP test
4. Use professional language.
5. Include a reference page using APA style.

Research Requests for Proposals

1. Pharmacokinetic and Pharmacodynamic Studies for Medications Development
The medications development program of the National Institute on Drug Abuse intends to solicit proposals to carry out clinical studies to determine the pharmacokinetics (PK) and pharmacodynamics (PD) of new medications for the treatment of substance use disorders. As medications are often taken with other treatment drugs or drugs of abuse (such as cocaine, methamphetamine, etc), information on the extent and nature of the interaction between the medications and other treatment drugs/drugs of abuse will also be a focus of this contract.

2. Transmission of Human Immunodeficiency Virus (HIV) In Semen
This research program will increase the basic and clinical knowledge of the biology of HIV in semen. Direct exposure to semen of HIV seropositive men is a major route for transmission of HIV type I. This Funding Opportunity Announcement (FOA) focuses on studies that will elucidate the factors that determine HIV shedding in the male genital tract. This includes studies that elucidate the infectivity of HIV in semen fractions, the effect of antiretroviral therapy on HIV infectivity in semen fractions, the relationship between the immunobiology of the male genital tract and HIV replication and infectivity, and factors such as genital tract inflammation which influence HIV transmission through semen.

3. Getting from Genes to Function in Lung Disease
Recent genetics studies of asthma, chronic obstructive pulmonary disease (COPD), sarcoidosis, idiopathic pulmonary fibrosis (IPF), and other lung-relevant phenotypes have clearly shown the usefulness of genome-wide association studies (GWAS) for gene discovery. Many genes or chromosomal regions have already been associated with lung dysfunction, and the number of related genes is expected to increase markedly over the next year as the results of ongoing meta-analyses and resequencing studies are published. In addition to genes already considered as candidates (e.g., RAD50, which is in the same linkage block as IL13, FcERA, TSLP), GWAS results have suggested involvement of many novel genes about which little is known. The identification of novel genes is especially significant because these may point to pathways and mechanisms not previously recognized in lung diseases. The purpose of this initiative is to accelerate research in functional genetics of lung diseases by supporting follow-up functional studies of particular genetic variants that have been linked to pulmonary conditions.

4. Developmental Mechanisms of Human Structural Birth Defects
Annually, almost five percent of all live births in the United States (more than 180,000 babies) involve babies born with birth defects, as broadly defined to include both structural and functional/metabolic abnormalities. Next to accidents, birth defects are the leading cause of death in children; they account for half of all pediatric hospitalizations. In terms of economic costs, billions of dollars are spent over the lifetimes of children born with any of 17 major, severe, nonfatal birth defects. In sum, structural birth defects have a great impact on public health, socioeconomics, and family life. A high priority goal of NICHD's strategic plan is to address the problem of structural birth defects.

5. The Eunice Kennedy Shriver National Institute of Child Health and Human Development
(NICHD) and Office of Dietary Supplements (ODS), National Institutes of Health (NIH) encourages innovative, multidisciplinary, interactive, and synergistic program project (P01) grant applications from institutes/organizations that propose to integrate basic, translational, and clinical approaches to understanding the developmental biology and genetic basis of congenital structural human malformations. To contain costs, each P01 will consist of only three component projects and associated cores. At least one project must propose basic research in an animal model system and at least one project must be clinical or translational in nature. The component projects must share a common central theme, focus, or objective on a specific developmental structural malformation or class of anomalies that is genotypically, mechanistically, biologically, or phenotypically analogous or homologous in both animal models and humans.

6. Nanoscience and Nanotechnology in Biology and Medicine
This initiative, issued by the National Institutes of Health, encourages applications from institutions/organizations that apply nanoscience and nanotechnology approaches to address problems in biology and medicine. The purpose of this FOA is to provide support for cutting-edge nanoscience and nanotechnology research that can lead to biomedical breakthroughs and new investigations into the diagnosis, treatment and management of an array of diseases and traumatic injuries. Nanoscience and nanotechnology have the capacity to drive a new wave of medical innovation through the engineering of bioactive nanoscale structures, processes and systems based on the advancement of our understanding of biology at the nanoscale. Therefore, this FOA will also support research projects that develop new or improved nanotechnology and nanoscience-based tools, methods, concepts, and devices that lead to a better understanding of basic biology in addition to conducting translational biomedical studies.

Attachment:- Letter of Intent.rar

Reference no: EM132901983

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