Discussion Post 3 HCR 577
Discussion Post 3 HCR 577
Due Apr 5 11:59pm
Available from Mar 15 until Apr 6
40 points possible
2 Replies, 2 Unread
2 Replies, 2 Unread
Discussion Topic: Module 3: Discussion Post Module 3: Discussion Post
Quality Testing of New Drugs
Discussion this week is two parts:
List and explain 2 quality control tests required for IND and new drug product submissions.
To earn full points your posts must be submitted on time. In your initial post you must list and explain two quality control tests for new drug product. In your Peer response you must pick 2 quality control tests from two different students, explain the purpose of these quality control tests and discuss if these are sufficient to demonstrate drug manufacturing is controlled.
BACKGROUND
- Identity
- Strength
- Purity
Pharmaceutical Chemistry
Just let me know if you can open the links. thanks, Marisol
- Stability Storage and Testing and Accelerated Ageing StudiesLinks to an external site.
- Extractables and LeachablesLinks to an external site.
- Method Development and ValidationLinks to an external site.
- QC (batch release) and Raw Materials TestingLinks to an external site.
- Residual Solvent TestingLinks to an external site.
- Water AnalysisLinks to an external site.
- Heavy Metals TestingLinks to an external site.
- Cleaning and Sterilization Validation of Reusable Medical DevicesLinks to an external site..
Pharmaceutical Microbiology
- Sterility TestingLinks to an external site.
- Antimicrobial Efficacy Testing (AET)Links to an external site.
- Microbial Limits TestingLinks to an external site.
- Bioburden DeterminationLinks to an external site.
- Endotoxin TestingLinks to an external site.
- Environmental Monitoring and IdentificationLinks to an external site.
- Water AnalysisLinks to an external site..
Wednesday by 11:59 p.m.
The initial post is worth up to 20 points. Initial posts should be at least 2 paragraphs, with each paragraph being at least 4-5 sentences in length.
Peer Responses
Respond to posts by two of your peers with additional ideas, questions, or thoughts. There is no length requirement, however responses should contribute substantially to the discussion. Make sure posts are engaging by asking questions, challenging each other in a professional manner, and providing new information for others to review and think about. You are expected to communicate respectfully and practice good netiquette in all course interactions. Remember that APA-style citations/references for any work or thoughts that are not your own are required.
Due on Sunday by 11:59pm.
Grading
Initial posts are worth up to a total of 20 points, and peer responses are worth up to an additional 20 points. See the grading rubric for a better understanding of how to get your best grade. To access the rubric, click on the three vertical lines at the top of the page and select “show rubric.”
Module 3 Discussion Rubric
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Criteria
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Ratings
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Pts
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This criterion is linked to a Learning OutcomeInitial Post
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20 ptsExcellentThe post is comprehensive and fully answers the discussion prompt. Student used complete sentences, appropriate tone, and clear language.
10 ptsGoodThe post is comprehensive, but does not fully answer the discussion prompt. Student used complete sentences, appropriate tone, and mostly clear language.
0 ptsNeeds Significant ImprovementThe posting is not comprehensive and does not answer the discussion prompt. Student used Incomplete sentences, inappropriate tone, and/or unclear language.
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20 pts
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This criterion is linked to a Learning OutcomeReply Post
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20 ptsExcellentStudent posted the required number of relevant peer responses, meeting all requirements.
10 ptsGoodStudent posted a response or responses but it was not relevant or did not significantly contribute to the discussion.
0 ptsNeeds Significant ImprovementStudent did not post a reply, or reply contained incomplete sentences, inappropriate tone, and/ or unclear language.
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20 pts
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Total Points: 40
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