APR Sept/Oct 2023 - 58

» FORMULATION AND DEVELOPMENT
»
When the sample dissolution results are normally distributed with
mean (µ) and standard deviation (σ). The probability of passing USP
dissolution test is given by:
(2)
(8)
For certain range of µ and σ P(T1
) and P(T1
T2
T3) are small when
compared to other probabilities in Eq (2). So, the probability of passing
USP dissolution test can be approximated by:
(3)
The probability of passing dissolution test is given by the following
equation:
Results and Discussions
(4)
Where:
(5)
The accuracy of the above method was tested by comparing the
results obtained from this code with reported values
a) Mean of dissolution was 75, Q was 75
b) Mean of dissolution was 80, Q was 75.
The results obtained using R code were comparable to reported results
from the Wang method.5
(6)
Φ = cumulative distribution function of standard normal distribution.
The probability of P(T2
T3.) can be approximated by P(D22
event D22 D33 is given by:
(7)
D33). The
SD
3
4
5
6
7
8
9
10
Table 2. Comparison probabilities, reported vs using R code.
From R code
0.625
0.625
0.625
0.625
0.625
0.625
0.625
0.625
Reported
0.625
0.625
0.625
0.625
0.625
0.625
0.625
0.625
The code can be used to estimate probability
The estimated probability using this method was calculated by using
Mathematica software.5
This paper aims to estimate the probability
from this method using a custom written code in R. R is an opensource
programming language and has distinct advantages over other
statistical software like being platform-independent. It is well suited
for performing statistical analysis.
x1 and x2 are independent and identically random variables from
normal distribution with mean (µ) and standard deviation (σ/√12).
The probability of P(T2
T3) is given by:
Figure 1. Probability of passing USP dissolution test with mean (75) and standard deviation (3 to 10 with increments of 0.5)
58 |
| September/October 2023
С
С
С
С
С
С

APR Sept/Oct 2023

Table of Contents for the Digital Edition of APR Sept/Oct 2023

INSIDER INSIGHT - From Guidelines to Standards: Why Comprehensive AI Regulation is Essential to Spurring Innovation
BIOPHARMACEUTICAL - Aseptic Process Simulation: Cell and Gene Therapy Manufacture
FORMULATION & DEVELOPMENT - Challenges of Analytical Validation for ATMPs
QC Corner - The Intricacies of Testing for Mycoplasmas in Cell Culture Systems
MICROBIOLOGY - Standardized, Scalable And Efficient: Producing Recombinant Factor C to Quality Standards
FORMULATION AND DEVELOPMENT - R Code to Estimate Probability of Passing USP Dissolution Test
FORMULATION AND DEVELOPMENT - Cloud Computing for Drug Discovery: The Time is Now
CGT CIRCUIT - Navigating the Complex Testing Strategies for Viral Vector-based Gene Therapies
MANUFACTURING - Simplifying Finished Product Manufacturer Site Transfer Variations
FORMULATION AND DEVELOPMENT - Advancing Regulatory Compliance with Natural Language Processing
DRUG DELIVERY - Finding a Greater Vantage Point for Creating Green Therapies
WHITEPAPER - Microbial Testing for the Pharmaceutical Industry
Facility Tour - Eurofins BioPharma Product Testing
ROUNDTABLE - Drug Delivery
MANUFACTURING - Accelerating Biologics R&D with Unified Software and Data Flows
An Interview with Jason Downing, Senior Product Manager, TriLink BioTechnologies®
FORMULATION AND DEVELOPMENT - The Role of Data in the Pharmaceutical Lifecycle
BIOPHARMACEUTICAL - Uniting Quality Expectations on Reinvigorated Biopharma Campuses
WHITEPAPER - VITAMIN C – Tableting with LUBRITAB® RBW Lubricant
WHITEPAPER - Leveraging Analytical Technology Process for CMC
BIOPHARMACEUTICAL - Maximizing the Commercialization Potential of Cell and Gene Therapies
MICROBIOLOGY - Comments on Aseptic Process Simulation (APS) in the New EU GMP Annex 1
VENDOR VIEWPOINT - Continuous & Intervention-Free Microbial Monitoring
APR Sept/Oct 2023 - Cover1
APR Sept/Oct 2023 - Cover2
APR Sept/Oct 2023 - 1
APR Sept/Oct 2023 - 2
APR Sept/Oct 2023 - 3
APR Sept/Oct 2023 - 4
APR Sept/Oct 2023 - 5
APR Sept/Oct 2023 - 6
APR Sept/Oct 2023 - 7
APR Sept/Oct 2023 - 8
APR Sept/Oct 2023 - 9
APR Sept/Oct 2023 - 10
APR Sept/Oct 2023 - 11
APR Sept/Oct 2023 - 12
APR Sept/Oct 2023 - 13
APR Sept/Oct 2023 - 14
APR Sept/Oct 2023 - 15
APR Sept/Oct 2023 - 16
APR Sept/Oct 2023 - 17
APR Sept/Oct 2023 - 18
APR Sept/Oct 2023 - 19
APR Sept/Oct 2023 - 20
APR Sept/Oct 2023 - 21
APR Sept/Oct 2023 - 22
APR Sept/Oct 2023 - 23
APR Sept/Oct 2023 - 24
APR Sept/Oct 2023 - 25
APR Sept/Oct 2023 - 26
APR Sept/Oct 2023 - 27
APR Sept/Oct 2023 - 28
APR Sept/Oct 2023 - 29
APR Sept/Oct 2023 - 30
APR Sept/Oct 2023 - INSIDER INSIGHT - From Guidelines to Standards: Why Comprehensive AI Regulation is Essential to Spurring Innovation
APR Sept/Oct 2023 - 32
APR Sept/Oct 2023 - 33
APR Sept/Oct 2023 - BIOPHARMACEUTICAL - Aseptic Process Simulation: Cell and Gene Therapy Manufacture
APR Sept/Oct 2023 - 35
APR Sept/Oct 2023 - 36
APR Sept/Oct 2023 - 37
APR Sept/Oct 2023 - 38
APR Sept/Oct 2023 - 39
APR Sept/Oct 2023 - 40
APR Sept/Oct 2023 - 41
APR Sept/Oct 2023 - 42
APR Sept/Oct 2023 - 43
APR Sept/Oct 2023 - FORMULATION & DEVELOPMENT - Challenges of Analytical Validation for ATMPs
APR Sept/Oct 2023 - 45
APR Sept/Oct 2023 - 46
APR Sept/Oct 2023 - 47
APR Sept/Oct 2023 - 48
APR Sept/Oct 2023 - 49
APR Sept/Oct 2023 - QC Corner - The Intricacies of Testing for Mycoplasmas in Cell Culture Systems
APR Sept/Oct 2023 - 51
APR Sept/Oct 2023 - MICROBIOLOGY - Standardized, Scalable And Efficient: Producing Recombinant Factor C to Quality Standards
APR Sept/Oct 2023 - 53
APR Sept/Oct 2023 - 54
APR Sept/Oct 2023 - 55
APR Sept/Oct 2023 - FORMULATION AND DEVELOPMENT - R Code to Estimate Probability of Passing USP Dissolution Test
APR Sept/Oct 2023 - 57
APR Sept/Oct 2023 - 58
APR Sept/Oct 2023 - 59
APR Sept/Oct 2023 - 60
APR Sept/Oct 2023 - 61
APR Sept/Oct 2023 - FORMULATION AND DEVELOPMENT - Cloud Computing for Drug Discovery: The Time is Now
APR Sept/Oct 2023 - 63
APR Sept/Oct 2023 - 64
APR Sept/Oct 2023 - 65
APR Sept/Oct 2023 - 66
APR Sept/Oct 2023 - 67
APR Sept/Oct 2023 - CGT CIRCUIT - Navigating the Complex Testing Strategies for Viral Vector-based Gene Therapies
APR Sept/Oct 2023 - 69
APR Sept/Oct 2023 - MANUFACTURING - Simplifying Finished Product Manufacturer Site Transfer Variations
APR Sept/Oct 2023 - 71
APR Sept/Oct 2023 - 72
APR Sept/Oct 2023 - 73
APR Sept/Oct 2023 - FORMULATION AND DEVELOPMENT - Advancing Regulatory Compliance with Natural Language Processing
APR Sept/Oct 2023 - 75
APR Sept/Oct 2023 - 76
APR Sept/Oct 2023 - 77
APR Sept/Oct 2023 - DRUG DELIVERY - Finding a Greater Vantage Point for Creating Green Therapies
APR Sept/Oct 2023 - 79
APR Sept/Oct 2023 - 80
APR Sept/Oct 2023 - 81
APR Sept/Oct 2023 - WHITEPAPER - Microbial Testing for the Pharmaceutical Industry
APR Sept/Oct 2023 - 83
APR Sept/Oct 2023 - 84
APR Sept/Oct 2023 - 85
APR Sept/Oct 2023 - Facility Tour - Eurofins BioPharma Product Testing
APR Sept/Oct 2023 - 87
APR Sept/Oct 2023 - 88
APR Sept/Oct 2023 - ROUNDTABLE - Drug Delivery
APR Sept/Oct 2023 - 90
APR Sept/Oct 2023 - 91
APR Sept/Oct 2023 - MANUFACTURING - Accelerating Biologics R&D with Unified Software and Data Flows
APR Sept/Oct 2023 - 93
APR Sept/Oct 2023 - An Interview with Jason Downing, Senior Product Manager, TriLink BioTechnologies®
APR Sept/Oct 2023 - 95
APR Sept/Oct 2023 - FORMULATION AND DEVELOPMENT - The Role of Data in the Pharmaceutical Lifecycle
APR Sept/Oct 2023 - 97
APR Sept/Oct 2023 - 98
APR Sept/Oct 2023 - BIOPHARMACEUTICAL - Uniting Quality Expectations on Reinvigorated Biopharma Campuses
APR Sept/Oct 2023 - 100
APR Sept/Oct 2023 - 101
APR Sept/Oct 2023 - WHITEPAPER - VITAMIN C – Tableting with LUBRITAB® RBW Lubricant
APR Sept/Oct 2023 - 103
APR Sept/Oct 2023 - WHITEPAPER - Leveraging Analytical Technology Process for CMC
APR Sept/Oct 2023 - 105
APR Sept/Oct 2023 - 106
APR Sept/Oct 2023 - BIOPHARMACEUTICAL - Maximizing the Commercialization Potential of Cell and Gene Therapies
APR Sept/Oct 2023 - 108
APR Sept/Oct 2023 - 109
APR Sept/Oct 2023 - MICROBIOLOGY - Comments on Aseptic Process Simulation (APS) in the New EU GMP Annex 1
APR Sept/Oct 2023 - 111
APR Sept/Oct 2023 - 112
APR Sept/Oct 2023 - 113
APR Sept/Oct 2023 - VENDOR VIEWPOINT - Continuous & Intervention-Free Microbial Monitoring
APR Sept/Oct 2023 - 115
APR Sept/Oct 2023 - 116
APR Sept/Oct 2023 - 117
APR Sept/Oct 2023 - 118
APR Sept/Oct 2023 - 119
APR Sept/Oct 2023 - 120
APR Sept/Oct 2023 - Cover3
APR Sept/Oct 2023 - Cover4
https://www.nxtbookmedia.com