Pharmaceuticals technology: Drug development and clinical trials
Order ID |
53563633773 |
Type |
Essay |
Writer Level |
Masters |
Style |
APA |
Sources/References |
4 |
Perfect Number of Pages to Order |
5-10 Pages |
Description/Paper Instructions
Pharmaceuticals technology: Drug development and clinical trials
Drug development is a complex and lengthy process that involves multiple stages of research and testing before a drug can be approved for use in patients. One of the critical stages in drug development is clinical trials, where the drug is tested in humans to determine its safety and effectiveness. In this essay, we will discuss the drug development process and the different phases of clinical trials.
Drug Development Process
The drug development process typically begins with the discovery of a new drug compound through basic research. The compound is then further developed and tested in preclinical studies to determine its safety and efficacy in animal models. If the preclinical studies show promising results, the drug can proceed to clinical trials.
Clinical Trials
Clinical trials are divided into three main phases, each with a specific objective.
Phase I Trials: Phase I trials are the first stage of clinical trials, and they involve testing the drug in a small group of healthy volunteers to determine its safety, tolerability, and pharmacokinetics (how the drug is absorbed, distributed, metabolized, and excreted in the body). Phase I trials typically involve fewer than 100 participants and can last several months.
Phase II Trials: If the drug is found to be safe and well-tolerated in Phase I trials, it can proceed to Phase II trials. Phase II trials are designed to determine the drug’s efficacy and optimal dosing regimen in a larger group of patients with the target disease. Phase II trials typically involve several hundred participants and can last up to two years.
Phase III Trials: If the drug shows promising results in Phase II trials, it can proceed to Phase III trials. Phase III trials are designed to confirm the drug’s safety and efficacy in a large group of patients with the target disease. Phase III trials typically involve several thousand participants and can last several years. The results of Phase III trials are used to support the drug’s regulatory approval by government agencies such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA).
After completing Phase III trials, the drug developer submits a New Drug Application (NDA) to the regulatory agency for approval. The regulatory agency reviews the drug’s safety, efficacy, and manufacturing processes to determine if it can be approved for use in patients. If approved, the drug can be marketed and sold to patients.
Conclusion
Drug development is a complex and lengthy process that requires significant investments of time and resources. Clinical trials are a critical part of the drug development process, allowing researchers to determine the drug’s safety and efficacy in humans. The three main phases of clinical trials have specific objectives, ranging from determining the drug’s safety and tolerability to confirming its efficacy in a large group of patients. If the drug is found to be safe and effective, it can be approved for use in patients and provide significant benefits to those who need it.
RUBRIC
QUALITY OF RESPONSE |
NO RESPONSE |
POOR / UNSATISFACTORY |
SATISFACTORY |
GOOD |
EXCELLENT |
Content (worth a maximum of 50% of the total points) |
Zero points: Student failed to submit the final paper. |
20 points out of 50: The essay illustrates poor understanding of the relevant material by failing to address or incorrectly addressing the relevant content; failing to identify or inaccurately explaining/defining key concepts/ideas; ignoring or incorrectly explaining key points/claims and the reasoning behind them; and/or incorrectly or inappropriately using terminology; and elements of the response are lacking. |
30 points out of 50: The essay illustrates a rudimentary understanding of the relevant material by mentioning but not full explaining the relevant content; identifying some of the key concepts/ideas though failing to fully or accurately explain many of them; using terminology, though sometimes inaccurately or inappropriately; and/or incorporating some key claims/points but failing to explain the reasoning behind them or doing so inaccurately. Elements of the required response may also be lacking. |
40 points out of 50: The essay illustrates solid understanding of the relevant material by correctly addressing most of the relevant content; identifying and explaining most of the key concepts/ideas; using correct terminology; explaining the reasoning behind most of the key points/claims; and/or where necessary or useful, substantiating some points with accurate examples. The answer is complete. |
50 points: The essay illustrates exemplary understanding of the relevant material by thoroughly and correctly addressing the relevant content; identifying and explaining all of the key concepts/ideas; using correct terminology explaining the reasoning behind key points/claims and substantiating, as necessary/useful, points with several accurate and illuminating examples. No aspects of the required answer are missing. |
Use of Sources (worth a maximum of 20% of the total points). |
Zero points: Student failed to include citations and/or references. Or the student failed to submit a final paper. |
5 out 20 points: Sources are seldom cited to support statements and/or format of citations are not recognizable as APA 6th Edition format. There are major errors in the formation of the references and citations. And/or there is a major reliance on highly questionable. The Student fails to provide an adequate synthesis of research collected for the paper. |
10 out 20 points: References to scholarly sources are occasionally given; many statements seem unsubstantiated. Frequent errors in APA 6th Edition format, leaving the reader confused about the source of the information. There are significant errors of the formation in the references and citations. And/or there is a significant use of highly questionable sources. |
15 out 20 points: Credible Scholarly sources are used effectively support claims and are, for the most part, clear and fairly represented. APA 6th Edition is used with only a few minor errors. There are minor errors in reference and/or citations. And/or there is some use of questionable sources. |
20 points: Credible scholarly sources are used to give compelling evidence to support claims and are clearly and fairly represented. APA 6th Edition format is used accurately and consistently. The student uses above the maximum required references in the development of the assignment. |
Grammar (worth maximum of 20% of total points) |
Zero points: Student failed to submit the final paper. |
5 points out of 20: The paper does not communicate ideas/points clearly due to inappropriate use of terminology and vague language; thoughts and sentences are disjointed or incomprehensible; organization lacking; and/or numerous grammatical, spelling/punctuation errors |
10 points out 20: The paper is often unclear and difficult to follow due to some inappropriate terminology and/or vague language; ideas may be fragmented, wandering and/or repetitive; poor organization; and/or some grammatical, spelling, punctuation errors |
15 points out of 20: The paper is mostly clear as a result of appropriate use of terminology and minimal vagueness; no tangents and no repetition; fairly good organization; almost perfect grammar, spelling, punctuation, and word usage. |
20 points: The paper is clear, concise, and a pleasure to read as a result of appropriate and precise use of terminology; total coherence of thoughts and presentation and logical organization; and the essay is error free. |
Structure of the Paper (worth 10% of total points) |
Zero points: Student failed to submit the final paper. |
3 points out of 10: Student needs to develop better formatting skills. The paper omits significant structural elements required for and APA 6th edition paper. Formatting of the paper has major flaws. The paper does not conform to APA 6th edition requirements whatsoever. |
5 points out of 10: Appearance of final paper demonstrates the student’s limited ability to format the paper. There are significant errors in formatting and/or the total omission of major components of an APA 6th edition paper. They can include the omission of the cover page, abstract, and page numbers. Additionally the page has major formatting issues with spacing or paragraph formation. Font size might not conform to size requirements. The student also significantly writes too large or too short of and paper |
7 points out of 10: Research paper presents an above-average use of formatting skills. The paper has slight errors within the paper. This can include small errors or omissions with the cover page, abstract, page number, and headers. There could be also slight formatting issues with the document spacing or the font Additionally the paper might slightly exceed or undershoot the specific number of required written pages for the assignment. |
10 points: Student provides a high-caliber, formatted paper. This includes an APA 6th edition cover page, abstract, page number, headers and is double spaced in 12’ Times Roman Font. Additionally, the paper conforms to the specific number of required written pages and neither goes over or under the specified length of the paper. |
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Pharmaceuticals technology: Drug development and clinical trials
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