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Learning Objectives

By completing this worksheet, you will be able to:

  • Create frequency distribution tables from pharmaceutical data
  • Calculate measures of central tendency with step-by-step reasoning
  • Apply Excel functions for statistical analysis
  • Interpret results in pharmaceutical manufacturing context
  • Understand data organization and presentation principles
๐Ÿญ Real-World Context

You're working as a Quality Control analyst at a pharmaceutical company. Your supervisor has asked you to analyze recent batch data from tablet production to ensure compliance with USP standards and identify any trends that might affect product quality.

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Part 1: Frequency Distribution Workshop

Understanding Frequency Distributions

Let's think step-by-step about why frequency distributions matter in pharmaceutical manufacturing:

๐Ÿง  Step-by-Step Reasoning: Why Frequency Distributions?

Step 1: Raw data tells us individual values, but patterns are hidden
Step 2: Grouping data reveals distribution shape and variability
Step 3: We can identify outliers and assess process control
Step 4: Regulatory compliance requires understanding data distributions

๐Ÿ“‹ Scenario: Tablet Weight Analysis

Below is weight data (in mg) from 30 tablets of acetaminophen 500 mg from Batch #TX2024-001:

Tablet Weight Data (mg) - Batch TX2024-001
548.2552.1549.8551.3550.7549.1
550.9548.7552.8549.5551.1550.3
549.7551.8550.1548.9552.3549.4
550.6549.2551.5550.8548.5552.0
549.9551.2550.4549.6551.7550.0

๐Ÿง  Step-by-Step: Creating a Frequency Distribution

Step 1: Determine the Range
Range = Maximum value - Minimum value
Range = 552.8 - 548.2 = 4.6 mg
Step 2: Choose Number of Classes
Using Sturges' Rule: k = 1 + 3.322 ร— logโ‚โ‚€(n)
k = 1 + 3.322 ร— logโ‚โ‚€(30) = 1 + 3.322 ร— 1.477 = 5.9 โ‰ˆ 6 classes
Step 3: Calculate Class Width
Class Width = Range รท Number of Classes
Class Width = 4.6 รท 6 = 0.77 mg โ‰ˆ 0.8 mg (rounded up for convenience)
Step 4: Create Class Intervals
Starting from 548.0 mg with width 0.8 mg

๐Ÿ“ Key Formulas

Range = Maximum - Minimum
Sturges' Rule: k = 1 + 3.322 ร— logโ‚โ‚€(n)
Class Width = Range รท Number of Classes
๐Ÿ’ป Excel Implementation

Range: =MAX(data_range) - MIN(data_range)

Logโ‚โ‚€: =LOG10(COUNT(data_range))

Sturges' Rule: =1 + 3.322*LOG10(COUNT(data_range))

๐Ÿ”ฅ Exercise 1.1: Complete the Frequency Distribution

Using the tablet weight data above, complete the frequency distribution table:

Class Interval (mg) Frequency Relative Frequency (%) Cumulative Frequency
548.0 - 548.8 ? ? ?
548.8 - 549.6 ? ? ?
549.6 - 550.4 ? ? ?
550.4 - 551.2 ? ? ?
551.2 - 552.0 ? ? ?
552.0 - 552.8 ? ? ?

Your Work Space:

Show your step-by-step counting process here...

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Part 2: Central Tendency Calculations

Mean (Arithmetic Average)

๐Ÿง  Step-by-Step: Calculating the Mean

Step 1: Understand What Mean Represents
The mean is the balance point of our data - it tells us the typical tablet weight
Step 2: Add All Values
Sum = 548.2 + 552.1 + 549.8 + ... + 550.0
Sum = 16,508.7 mg
Step 3: Divide by Count
Mean = Sum รท n = 16,508.7 รท 30 = 550.29 mg
Step 4: Interpret the Result
The average tablet weight is 550.29 mg, which is close to our target of 550 mg

๐Ÿ“ Mean Formula

Mean (xฬ„) = (ฮฃx) / n

Where: ฮฃx = sum of all values, n = number of observations

๐Ÿ’ป Excel Function

=AVERAGE(A1:F5) where A1:F5 contains your tablet weight data

Alternative: =SUM(A1:F5)/COUNT(A1:F5)

Median (Middle Value)

๐Ÿง  Step-by-Step: Finding the Median

Step 1: Sort Data in Ascending Order
548.2, 548.5, 548.7, 548.9, 549.1, 549.2, 549.4, 549.5, 549.6, 549.7, 549.8, 549.9, 550.0, 550.1, 550.3, 550.4, 550.6, 550.7, 550.8, 550.9, 551.1, 551.2, 551.3, 551.5, 551.7, 551.8, 552.0, 552.1, 552.3, 552.8
Step 2: Find Middle Position
With n = 30 (even number), median position = (n+1)/2 = 15.5
So we need the average of 15th and 16th values
Step 3: Identify Middle Values
15th value = 550.3 mg
16th value = 550.4 mg
Step 4: Calculate Median
Median = (550.3 + 550.4) รท 2 = 550.35 mg
๐Ÿ’ป Excel Function

=MEDIAN(A1:F5) automatically sorts and finds the middle value

Mode (Most Frequent Value)

๐Ÿง  Step-by-Step: Finding the Mode

Step 1: Count Frequency of Each Value
Look for values that appear more than once in our dataset
Step 2: Examine Our Data
In this dataset, each weight value appears only once
Step 3: Conclusion
No mode exists (no value repeats) - this dataset is amodal
Step 4: Practical Interpretation
This suggests good manufacturing precision - weights are well-distributed
๐Ÿ’ป Excel Function

=MODE.SNGL(A1:F5) for single mode

=MODE.MULT(A1:F5) for multiple modes

Note: Returns #N/A if no mode exists

๐Ÿ”ฅ Exercise 2.1: Content Uniformity Analysis

You receive the following assay results (% of labeled claim) for 10 tablets from a different batch:

Content Uniformity Data (% of labeled claim)
98.799.8101.2100.199.3
100.798.999.8100.5101.0

Calculate (show all steps):

a) Mean:

Step 1: Sum = _____________

Step 2: Mean = Sum รท n = _____ รท 10 = _____


b) Median:

Step 1: Sorted data: _________________________

Step 2: Middle positions (5th and 6th): _____ and _____

Step 3: Median = (___ + ___) รท 2 = _____


c) Mode:

Value that appears most frequently: _____


d) Excel Formulas:

Mean: _______________

Median: _______________

Mode: _______________

Pharmaceutical Interpretation Tip: For content uniformity, we typically want mean close to 100%, low variability, and no extreme outliers. USP requires individual values between 85-115% with no more than one outside 85-105%.
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Part 3: Excel Functions Laboratory

Essential Statistical Functions

Basic Descriptive Statistics

=AVERAGE(range) - Arithmetic mean

=MEDIAN(range) - Middle value

=MODE.SNGL(range) - Most frequent value

=COUNT(range) - Count of numeric values

=MAX(range) - Largest value

=MIN(range) - Smallest value

Advanced Functions

=QUARTILE.INC(range, quartile) - Quartiles (0,1,2,3)

=PERCENTILE.INC(range, k) - kth percentile

=FREQUENCY(data_array, bins_array) - Frequency distribution

=COUNTIF(range, criteria) - Conditional counting

๐Ÿง  Step-by-Step: Using FREQUENCY Function

Step 1: Set Up Your Bins
Create bins in column C: 548.8, 549.6, 550.4, 551.2, 552.0, 552.8
Step 2: Select Output Range
Select cells D2:D7 (one more cell than bins)
Step 3: Enter Array Formula
Type: =FREQUENCY(A1:F5,C2:C7) then press Ctrl+Shift+Enter
Step 4: Interpret Results
Each cell shows count of values in that range

๐Ÿ”ฅ Exercise 3.1: Excel Mastery Challenge

Using the dissolution data below (% dissolved at 30 minutes), create a complete Excel analysis:

Dissolution Data (% dissolved at 30 min)
85.287.884.186.985.787.2
86.384.887.585.486.184.9

Task 1: Write Excel formulas for the following:

a) Mean: _______________

b) Median: _______________

c) Maximum: _______________

d) Minimum: _______________

e) Count: _______________


Task 2: Create bins for frequency analysis:

Bins (every 1%): 84, 85, 86, 87, 88

Frequency formula: _______________


Task 3: Interpretation

Based on your results, comment on the dissolution performance:

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