Magic Dust 1 Drug Development Plan Case Study

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Description

Utilize the following case study to evaluate and communicate your thinking on developing a regulatory submission for a new drug product in Common Technical Document format:

Imagine that you, as a regulatory science expert, go camping in a remote area of the world and find an isolated tribe of people that has not yet communicated with the rest of the world. You discover that this tribe uses several types of "magic dust" to treat a wide variety of human ailments, each with varying safety profiles and degrees of efficacy. For example, the tribe uses "magic dust #1" to treat headaches, nausea, fever and mild systemic pain, "magic dust #2" to treat cuts and bruises, and "magic dust #3" to treat insect bites. In fact, you observe that the tribe has isolated or developed at least 12 different kinds of "magic dust" and your observations suggest that the "magic dust" category as a whole seems to have a novel mechanism of action. You ask the tribe if you can have samples of each magic dust type to bring back with you for analysis and they agree. When you get home, you give these samples to the medical community, which discovers that indeed, these "magic dusts" might possibly be used effectively in the US to treat the conditions for which they are utilized by the tribe, and that their mechanism of action is, indeed, unique.

As a regulatory expert, you are charged with developing a plan to support an NDA submission to FDA for the first magic dust of your choosing. As you know, as of May 2017, all NDA’s must be submitted to FDA using the Common Technical Document (CTD) format. Your plan should address the following "magic dust" associated questions and/or issues:

1) What pre-clinical requirements should be included and summarized and in what CTD Module?

2) How can the indications for use for each "magic dust" be isolated and refined? Why is it important to do this?

3) What clinical requirements should govern their approval for general use in study populations and where should this information be incorporated into the CTD?

4) How can the risk vs. benefit profile associated with utilization of the "magic dust" for clinical purposes be established and where should this be described in the CTD submission?

5) What types of quality associated documentation should be incorporated into the submission and where should this information be included in the CTD?

6) What are the components of the study including inclusion and exclusion criteria in each phase of clinical evaluation?

7) What is the general overall structure/outline of the appropriate CTD submission and what would the outline look like?

Note that you can make as many assumptions as you need to here, but these assumptions should be clearly explained and/or defined.

Important point :- Out of 12 magic dust just focus on any one throughout the paper. Since the indications for the magic dust #1, #2 and #3 is mentioned you need to choose any 1 magic dust with given indications out of 3 and just focus on that one magic dust throught the paper to answer all the 7 questions.

pages :- 12

Do include tables or pictures wherever possible.

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Explanation & Answer

Hey buddy, the question is finally complete. Below, I have attached 4 files. They are as follows;1. The answers meeting the prompt's requirements in line with the structure provided above. Answers are labelled 😇2. An outline for the report3. A word count document without the cover page, reference page, headings, tables and figures. Evidence the report is 12 full pages. 4. A Turn it in Report that proves that ALL ANSWERS are original. 😇

Running head: MAGIC DUST 1 DRUG DEVELOPMENT PLAN

Magic Dust 1 Drug Development Plan
Student’s Name
Institutional Affiliation

1

MAGIC DUST 1 DRUG DEVELOPMENT PLAN

Magic Dust 1 Drug Development Plan
Introduction
Drug development controls in the USA are a mandate for the FDA. The control body
provides guidelines for the new drug application (NDA) formats and structure, which should be
prepared following the CTD structure. The structure has five modules, namely Modules 1,2,3,4
and 5. The FDA provides specific standard guides for each Module to ensure uniformity in the
NDA submissions, hence easy tracking of compliance. This paper focuses on the preclinical
requirements for the NDA compliance for Magic dust 1 with the FDA guidelines. The preclinical
guidelines are provided and summarized in Module 2 of the CTD. However, module 4 provides
preclinical reports. Secondly, the paper discusses how #Magic dust 1 drug indications were
isolated and refined based on usage and administration, age, special interest groups, and dosages.
The FDA's clinical requirements for inclusion in CTD, such as clinical summary, clinical
overviews, and clinical reports, are also discussed. Each clinical requirement is contained in
specific modules of the CTD. The paper also provides the #Magic dust1 drug's risk-benefit
analysis as guided by the CTD module 2. Besides, the quality controls of the #Magic dust 1 as
guided by the overall quality summaries (QOS) of module 2 and the drug’s quality reports such
as chemical analysis results are discussed. Additionally, the paper outlines the components of the
#Magic dust one clinical studies contained in the four phases and the inclusion and exclusion
criteria for selecting the participants. Lastly, the paper provides the #Magic dust CTD's overall
structure submitted to the FDA for approval.
1.
Preclinical requirements

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MAGIC DUST 1 DRUG DEVELOPMENT PLAN

Preclinical requirements involve laboratory drug tests on animals done before actual tests
are performed on humans. The animal trials provide preliminary safety information of the drug
necessary to establish drug characteristics such as toxicity, which guides the dosage prescriptions
for first human trials. Therefore, the FDA provides guidelines for the preclinical studies before
approving the drug development to proceed for the clinical stage. For instance, #Magic dust drug
development was subjected to the FDA's preclinical research requirements outlined in the CTD
Module.
Preclinical overview
First, the preclinical overview of the drug should be indicated in the CTD submission.
FDA provides guidelines for preclinical overview in the CTD module 2 (FDA 2017) (4). The
preclinical overview summarizes studies such as pharmacology and toxicology studies done on
animals. For example, the preclinical overview of #Magic dust 1 indicates that the toxicology
studies on pregnant rants showed high toxicity of the drug; hence reduced dosage was
recommended. The CTDs laboratory study and test systems should follow the laid down
protocols. The laboratory studies for FDA drug approval applications should adhere to the
quality system approaches such as acceptable laboratory practices (FDA 2020) (2). For example,
the #Magic dust 1 drug applications forwarded to the FDA contained toxicity and safety
preclinical results that supported the application.
Preclinical summary
Also, the preclinical summary of animal trials for #Magic dust was indicated in the CTD
module 2. The #Magic dust preclinical summary followed the FDA requirement for the
preclinical research identification, data filings, and the specimen's recording criteria during the
laboratory study. The specimen information is indicated in the container, while data recordings

3

MAGIC DUST 1 DRUG DEVELOPMENT PLAN

during the laboratory research should be done promptly, written in ink, and dated (FDA 2016,
(3); FDA, 2019 (6). The laboratory toxicity test results for #Magic dust were signed by the
clinician who did the trials. The identification of the #Magic dust drug specimens was made
within the requirements of the FDA.
Preclinical report
A proper review of the preclinical reports is another essential requirement for the NDA
applications whereby any changes in the recorded initial findings should indicate the reason for
the change. For example, the #Magic dust1 preclinical study indicated that the researcher
reviewed the data on the impact of #Magic dust1 drug on pregnant rats. Initially, the results
indicated that the drug caused premature births. However, further studies showed that the
pregnant rat that reported premature birth had preexisting conditions since other trials showed no
adverse effect. Therefore, the earlier findings were amended on the automated report and
preclinical reports of the Magic dust drug were indicated in CTD module 4.
The preclinical results are forwarded to the FDA using the CTD format. Preclinical
research of drug development such as toxicology, pharmacology, and pharmacokinetics are
documented in the CTD module 3. The drug's recommended safety and effectiveness are
indicated in the Module as guided by the animal trials findings. For example, the toxicolo...


Anonymous
Really great stuff, couldn't ask for more.

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