Biostatistics Worksheet

All conclusion are frivolous unless supported by statisticsAssignment 4: Do not ask anyone other than professor for help or clarification. You w
YOU must show all formulas and calculations, charts in excel
USE EXCEL and show all your calculations. Alternate methods: must be specified and all calculation with alterna
Answer includes statistical data analysis in a easy to read format, please do not data dump . Use more space as y
CONCLUSION: MUST Start with “CONCLUSION”
Analytical Method Transfer (USP 1224) Guideline – Pharma …
https://pharmabeginers.com › analytical-method-transfer…
23-Jan-21
CONFIDENCE.NORM(alpha,standard_dev,size
Q1:
3 points
Describe in 3 to 5 sentences:
What is Total Deviation
What is sum of square
What is variance
The following questions (2 to 6) use the information and data set shown below:
Pharmaceutical Analytical Method Transfer from Lab A (TU) to Lab B (RU 1) and Lab C (RU 2)
There were a total of 10 samples analyzed by 3 labs and each sample was tested in duplicate, run 1
Labs randomized samples so that there was no bias, e.g., LAB A Analyzed Sample in a Radom sequen
The assay values are shown here:
Select data from only one of runs from one of the labs and calculate Total Deviation, Sum of Squa
Lab A
Lab A
sample number
Run1
Run2
10
102
101
8
100
100
4
100
103
2
101
102
1
100
101
9
101
101
6
101
101
7
102
102
5
101
99
3
102
99
Q2
3 points
sample number
1
8
6
5
9
4
3
2
10
7
Lab B
Run 1
101
102
105
103
103
104
102
101
101
105
Lab B
Run2
101
103
105
102
103
104
102
101
101
105
sample number
1
10
4
3
6
5
8
2
7
9
Lab C
Run1
99
104
106
104
103
105
104
102
98
107
Lab C
Run2
97
105
107
105
101
106
102
102
99
108
Only one batch ANSWER:
Batch and Run:
Total Deviation
Sum of Square
Variance
For next questions:
Information
CLAIM:
The company claims that the analytical method transfer is successful from its head quarter Lab A (to) to Lab B (Ru
The company’s internal operating procedure requires 3 criteria must be met for a successful transfer.
1 ANOVA at alpha 0.05 provides acceptable p values for (1) between lab (Reproducibility) and (2) runs
2 The mean values of 10 samples be within +/- 2 % of the Transferring lab and receiving labs
3 None of the individual sample be outside +/- 5% between Transferring lab and Receiving labs
Q3
2 points
Write two separate hypothesis to evaluate the ANOVA claim.
Hypothesis 1
Ho: 1
H1: 1
2 points
Hypothesis 2
Ho: 2
H1: 2
Q 3:
Use ANOVA to test your hypothesis 1, Ho:1 and alternative hypothesis 1, H1:1
Use ANOVA to test your hypothesis 2, Ho:1 and alternative hypothesis 2, H1:1
Q 4:
8 points
Show/ describe the method you used.
Highlight:
Mean and variance
Tabulate Results:
Hypothesis 1: F test
F Critical
Alpha
P
Hypothesis 2: F test
F Critical
Alpha
P
Q5
2 points
In detail (multiple statements) to explain P values limitations in this case.
Q6
3 Points
CONCLUSION: (one liner answer gets 0)
Use ANOVA findings and criteria company uses.
Separately, discuss justification of your conclusion with statistical distribution graph
Q7
NEW DATA SET
The random sample of 12 students from Pharmaceutics were collected to determine retention of information (als
The comp exam contained four courses and score out of 25 for each course is shown in the table below.
Create a correlation matrix to compare relationship between various courses and total comp score
Pharmaceutics requires total score of > 75 to pass the exam
In addition, it also collects information on an
Student No.
10000001
10000002
10000003
10000004
10000005
10000006
10000007
10000008
10000009
10000010
10000011
10000012
Biostat
20
18
17
20
14
20
15
20
23
19
19
21
Cosmetic Lab
23
22
25
20
24
23
24
20
22
24
23
21
1 Point
Write a Claim
2 point
Show statistical correlation matrix
2 Point
CONCLUSION: (one liner answer gets 0)
Q8
NEW INFORMATION
Differential eq Reg Affairs
18
22
20
21
21
25
19
18
23
24
22
22
17
24
19
15
21
21
21
23
20
21
21
20
Total
83
81
88
77
85
87
80
74
87
87
83
83
The random sample of 12 students from Pharmaceutics were collected to determine retention of information (als
The comp exam contained four courses and score out of 25 for each course is shown in the table below.
Perform multiple regression analysis and write equation for the total score as a Function of each of the individua
Student No.
10000001
10000002
10000003
10000004
10000005
10000006
10000007
10000008
10000009
10000010
10000011
10000012
Biostat
20
18
17
20
14
20
15
20
23
19
19
21
Cosmetic Lab
23
22
25
20
24
23
24
20
22
24
23
21
Differential eq Reg Affairs
18
22
20
21
21
25
19
18
23
24
22
22
17
24
19
15
21
21
21
23
20
21
21
20
2 points
Multiple regression analysis and regression equation
2 Point
Conclusion based on ANOVA
2
Total
83
81
88
77
85
87
80
74
87
87
83
83
101
100
103
98
99
100
97
103
97
98