scholarly journals Common deficiencies found in generic Finished Pharmaceutical Product (FPP) applications submitted for registration to the South African Health Products Regulatory Authority (SAHPRA)

2022 ◽  
Vol 15 (1) ◽  
Author(s):  
Lerato Moeti ◽  
Madira Litedu ◽  
Jacques Joubert
Keyword(s):  
Sample Size ◽  
Sample Size Calculation ◽  
Pharmaceutical Product ◽  
Systematic Sampling ◽  
Multi Stage ◽  
African Health ◽  
Therapeutic Category ◽  
Health Products ◽  
Container Closure ◽  
Selection Of

Abstract Background The aim of the study was to investigate the common deficiencies observed in the Finished Pharmaceutical Product (FPP) section of generic product applications submitted to SAHPRA. The study was conducted retrospectively over a 7-year period (2011–2017) for products that were finalised by the Pharmaceutical and Analytical pre-registration Unit. Methods There were 3148 finalised products in 2011–2017, 667 of which were sterile while 2089 were non-sterile. In order to attain a representative sample for the study, statistical sampling was conducted. Sample size was obtained using the statistical tables found in literature and confirmed by a sample size calculation with a 95% confidence level. The selection of the products was according to the therapeutic category using the multi-stage sampling method called stratified-systematic sampling. This resulted in the selection of 325 applications for non-sterile products and 244 applications for sterile products. Subsequently, all the deficiencies were collected and categorised according to Common Technical Document (CTD) subsections of the FPP section (3.2.P). Results A total of 3253 deficiencies were collected from 325 non-sterile applications while 2742 deficiencies were collected from 244 sterile applications. The most common deficiencies in the FPP section for non-sterile products were on the following sections: Specifications (15%), Description and Composition (14%), Description of the Manufacturing Process (13%), Stability Data (7.6%) and the Container Closure System (7.3%). The deficiencies applicable to the sterile products were quantified and the subsection, Validation and/or Evaluation (18%) has the most deficiencies. Comparison of the deficiencies with those reported by other agencies such as the USFDA, EMA, TFDA and WHOPQTm are discussed with similarities outlined. Conclusions The overall top five most common deficiencies observed by SAHPRA were extensively discussed for the generic products. The findings provide an overview on the submissions and regulatory considerations for generic applications in South Africa, which is useful for FPP manufacturers in the compilation of their dossiers and will assist in accelerating the registration process.

scholarly journals Uncertainty Analysis in Population-Based Disease Microsimulation Models

2012 ◽  
Vol 2012 ◽  
pp. 1-14 ◽  
Author(s):  
Behnam Sharif ◽  
Jacek A. Kopec ◽  
Hubert Wong ◽  
Philippe Finès ◽  
Eric C. Sayre ◽  
...  
Keyword(s):  
Uncertainty Analysis ◽  
Sample Size ◽  
Sample Size Calculation ◽  
Population Based ◽  
Computational Time ◽  
Microsimulation Model ◽  
Simulated Population ◽  
Expository Paper ◽  
Microsimulation Models ◽  
Selection Of

Objective. Uncertainty analysis (UA) is an important part of simulation model validation. However, literature is imprecise as to how UA should be performed in the context of population-based microsimulation (PMS) models. In this expository paper, we discuss a practical approach to UA for such models. Methods. By adapting common concepts from published UA guidelines, we developed a comprehensive, step-by-step approach to UA in PMS models, including sample size calculation to reduce the computational time. As an illustration, we performed UA for POHEM-OA, a microsimulation model of osteoarthritis (OA) in Canada. Results. The resulting sample size of the simulated population was 500,000 and the number of Monte Carlo (MC) runs was 785 for 12-hour computational time. The estimated 95% uncertainty intervals for the prevalence of OA in Canada in 2021 were 0.09 to 0.18 for men and 0.15 to 0.23 for women. The uncertainty surrounding the sex-specific prevalence of OA increased over time. Conclusion. The proposed approach to UA considers the challenges specific to PMS models, such as selection of parameters and calculation of MC runs and population size to reduce computational burden. Our example of UA shows that the proposed approach is feasible. Estimation of uncertainty intervals should become a standard practice in the reporting of results from PMS models.

scholarly journals How should a clinician interpret results of randomized controlled trials?

2010 ◽  
Vol 17 (1-2) ◽  
pp. 30-34
Author(s):  
Virginijus ŠAPOKA ◽  
Vytautas KASIULEVIČIUS ◽  
Janina DIDŽIAPETRIENĖ
Keyword(s):  
Randomized Controlled Trials ◽  
Sample Size ◽  
Controlled Trial ◽  
Sample Size Calculation ◽  
Study Groups ◽  
Controlled Trials ◽  
Random Allocation ◽  
Equivalence Testing ◽  
Randomized Controlled ◽  
Selection Of

Randomized controlled trials (RCTs) and systematic reviews are the most reliable methods of determining the effects of treatment. The randomization procedure gives a randomized controlled trial its strength. Random allocation means that all participants have the same chance of being assigned to each of the study groups. The choice of which end point(s) to select is critical to any study design. Intention-to-treat is the preferred approach to the analysis of clinical trials. Sample size calculations and data analyses have an important impact on the planning, interpretation, and conclusions of randomized trials. In this article, we discuss the problematic areas that can affect the outcome of a trial, such as blinding, sample size calculation, randomization; concealment allocation; intention of treating the analysis; selection of end points; selection of traditional versus equivalence testing, early stopped trials, selective publications. Keywords: randomized controlled trials, sample size, outcomes, type of analyses

scholarly journals A Study on Constraints Faced by Tribals in Availing Benefits from Different Tribal Development Schemes in Jammu and Kashmir State

2020 ◽  
pp. 1-4
Author(s):  
Tariq Iqbal ◽  
Rakesh Nanda ◽  
Rajinder Peshin ◽  
Shazia Paswal
Keyword(s):  
Sample Size ◽  
Government Intervention ◽  
Sampling Technique ◽  
Total Sample ◽  
Interview Schedule ◽  
Jammu And Kashmir ◽  
Total Sample Size ◽  
Multi Stage ◽  
Selection Of ◽  
Lack Of Knowledge

The study was conducted to find out the constraints faced by gujjars and bakerwals in availing the benefits of tribal developmental schemes in Jammu division of Jammu and Kashmir State. Multi-stage sampling technique was employed for the selection of districts, blocks, villages and ultimate respondents. The total sample size was 112. Pretested interview schedule was used for the collection of data. The major finding of the study revealed that lack of proper awareness followed by lack of knowledge of government intervention (66%), adequacy of funds (41%), High illiteracy rate among the respondents and living in the far-flung area are the major constraints which are faced by tribal in availing the benefits from Tribals developmental schemes.

Modified Sieve Sampling: A Method for Single- and Multi-Stage Probability- Proportional-to-Size Sampling

2010 ◽  
Vol 29 (1) ◽  
pp. 125-148 ◽  
Author(s):  
Lucas A. Hoogduin ◽  
Thomas W. Hall ◽  
Jeffrey J. Tsay
Keyword(s):  
Sample Size ◽  
Single Stage ◽  
New Method ◽  
Systematic Sampling ◽  
Reliable Control ◽  
Selection Methods ◽  
Sample Sizes ◽  
Precise Control ◽  
Multi Stage ◽  
Efficiency Measures

SUMMARY: Widely used probability-proportional-to-size (PPS) selection methods are not well adapted to circumstances requiring sample augmentation. Limitations include: (1) an inability to augment selections while maintaining PPS properties, (2) a failure to recognize changes in census stratum membership which result from sample augmentation, and (3) imprecise control over line item sample size. This paper presents a new method of PPS selection, a modified version of sieve sampling which overcomes these limitations. Simulations indicate the new method effectively maintains sampling stratum PPS properties in single- and multi-stage samples, appropriately recognizes changes in census stratum membership which result from sample augmentation, and provides precise control over line item sample sizes. In single-stage applications the method provides reliable control of sampling risk over varied tainting levels and error bunching patterns. Tightness and efficiency measures are comparable to randomized systematic sampling and superior to sieve sampling.

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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