Shiny Tools for Sample Size Calculation in Process Performance Qualification of Large Molecules

2019 ◽  
pp. 71-86
Author(s):  
Qianqiu Li ◽  
Bill Pikounis
Keyword(s):  
Sample Size ◽  
Sample Size Calculation ◽  
Process Performance ◽  
Large Molecules ◽  
Performance Qualification ◽  
Process Performance Qualification

scholarly journals Stage 2 Process Performance Qualification (PPQ): a Scientific Approach to Determine the Number of PPQ Batches

2015 ◽  
Vol 17 (4) ◽  
pp. 829-833 ◽  
Author(s):  
Ajay Pazhayattil ◽  
Daniel Alsmeyer ◽  
Shu Chen ◽  
Maksuda Hye ◽  
Marzena Ingram ◽  
...  
Keyword(s):  
Process Performance ◽  
Performance Qualification ◽  
Scientific Approach ◽  
Process Performance Qualification

PQ Forum #21 - Validation Initiation Document Template

2021 ◽  
Vol 27 (4) ◽  
Author(s):  
Paul Pluta
Keyword(s):  
Pharmaceutical Manufacturing ◽  
Process Performance ◽  
Manufacturing Facility ◽  
External Review ◽  
Performance Qualification ◽  
Product Lifetime ◽  
Process Performance Qualification

Validation documents are key documents in a pharmaceutical manufacturing facility. Validation documents must be carefully written for internal and external review including audit by regulatory inspectors; they may be accessed numerous times during a product lifetime. The most frequently reviewed validation documents are Stage 2 Process Performance Qualification documents.

The most frequently asked question to a statistician: The sample size

2017 ◽  
Vol 23 (5) ◽  
pp. 644-646 ◽  
Author(s):  
Maria Pia Sormani
Keyword(s):  
Clinical Study ◽  
Sample Size ◽  
Study Design ◽  
Treatment Effect ◽  
Sample Size Calculation ◽  
Ethical Implications ◽  
Number Of Patients ◽  
Reducing Costs ◽  
Correct Size

The calculation of the sample size needed for a clinical study is the challenge most frequently put to statisticians, and it is one of the most relevant issues in the study design. The correct size of the study sample optimizes the number of patients needed to get the result, that is, to detect the minimum treatment effect that is clinically relevant. Minimizing the sample size of a study has the advantage of reducing costs, enhancing feasibility, and also has ethical implications. In this brief report, I will explore the main concepts on which the sample size calculation is based.

Sample size calculation for clinical trials in which entry criteria and outcomes are counts of events

1994 ◽  
Vol 13 (8) ◽  
pp. 859-870 ◽  
Author(s):  
Robert P. McMahon ◽  
Michael Proschan ◽  
Nancy L. Geller ◽  
Peter H. Stone ◽  
George Sopko
Keyword(s):  
Clinical Trials ◽  
Sample Size ◽  
Sample Size Calculation

scholarly journals Prevalence of Ectopic Eruption, Impaction, Retention and Agenesis of the Permanent Second Molar

2007 ◽  
Vol 77 (5) ◽  
pp. 773-778 ◽  
Author(s):  
Lars Bondemark ◽  
Jola Tsiopa
Keyword(s):  
Early Diagnosis ◽  
Sample Size ◽  
Sample Size Calculation ◽  
Optimal Time ◽  
Second Molar ◽  
Ectopic Eruption ◽  
Delayed Eruption ◽  
Dental Records ◽  
The Times ◽  
The City

Abstract Objective: To elucidate the prevalence of ectopic eruption, impaction, and primary and secondary retention as well as agenesis of the permanent second molar (M2) among adolescents. Materials and Methods: After a sample size calculation, dental records, including radiographs, of 1543 patients (722 girls and 821 boys), from three clinics in the city of Malmoe, Sweden, were retrospectively analyzed. Series of annual records and radiographs were examined for all patients from 10 to 16 years of age and were carried out during 2004–2006. The prevalence of ectopic eruption, impaction, and primary and secondary retention as well as agenesis of M2s was registered in a standardized manner and according to preset definitions. In addition, the times of emergence of the M2s were recorded. Results: The prevalence of ectopic eruption of M2 was 1.5%, the prevalence of primary retention was 0.6%, and the prevalence of impaction was 0.2%. This means that the overall prevalence of eruption disturbances was 2.3%. In addition, the prevalence of agenesis was 0.8%. The prevalence of ectopic eruption was significantly higher in the mandible. Those patients with eruption disturbances and agenesis of M2 showed significantly delayed eruption of their other M2s compared to the individuals without any eruption disturbances. Conclusions: The prevalence of eruption disturbances was higher than reported earlier, and, even if the disturbances do not occur frequently, it is important to develop an early diagnosis in order to start the treatment at the optimal time.

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