Multi-stage multivariate modeling of temporal patterns in prescription counts for competing drugs in a therapeutic category

2017 ◽  
Vol 34 (1) ◽  
pp. 61-78 ◽  
Author(s):  
Volodymyr Serhiyenko ◽  
Nalini Ravishanker ◽  
Rajkumar Venkatesan
Keyword(s):  
Temporal Patterns ◽  
Multivariate Modeling ◽  
Multi Stage ◽  
Therapeutic Category

Rejoinder to ‘Multi-stage multivariate modeling of temporal patterns in prescription counts for competing drugs in a therapeutic category’

2018 ◽  
Vol 34 (1) ◽  
pp. 82-83
Author(s):  
Volodymyr Serhiyenko ◽  
Nalini Ravishanker ◽  
Rajkumar Venkatesan
Keyword(s):  
Temporal Patterns ◽  
Multivariate Modeling ◽  
Multi Stage ◽  
Therapeutic Category

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.

Temporal Patterns for Pitch and Loudness

1978 ◽  
Vol 23 (11) ◽  
pp. 856-857
Author(s):  
W. LAWRENCE GULICK
Keyword(s):  
Temporal Patterns

Planning and Search in Multi-Stage Risky Decision Making

2011 ◽  
Author(s):  
Jared Hotaling ◽  
Jerry Busemeyer ◽  
Richard Shiffrin
Keyword(s):  
Decision Making ◽  
Risky Decision Making ◽  
Risky Decision ◽  
Multi Stage

Temporal patterns of flow in the workplace

2013 ◽  
Author(s):  
J. Navarro ◽  
L. Ceja ◽  
J. Poppelbaum ◽  
D. Gomes
Keyword(s):  
Temporal Patterns

SPATIO-TEMPORAL PATTERNS OF WORKFORCE IN INDIA DURING 1981-2011

2019 ◽  
Vol 38 (2) ◽  
pp. 239-254
Author(s):  
M.B. SINGH ◽  
◽  
NITIN KUMAR MISHRA ◽  
Keyword(s):  
Temporal Patterns ◽  
Spatio Temporal

Effects of Cooking Oil Subsidy Removals on Related Markets in Malaysia: A Comparative Static, Multicommodity, Multi Stage Production Approach

2011 ◽  
Author(s):  
Jamal Othman ◽  
Yaghoob Jafari
Keyword(s):  
Equilibrium Model ◽  
Comparative Statics ◽  
Partial Equilibrium ◽  
Cooking Oil ◽  
Multi Stage ◽  
Supply Factor ◽  
Partial Equilibrium Model ◽  
Factor Markets ◽  
Input Markets ◽  
Production Approach

Malaysia is contemplating removal of most of her subsidy support measures including subsidies on cooking oil which is largely palm oil based. This paper aims to examine the effects of cooking oil subsidy removals on the competitiveness of the oil palm subsector and related markets. This is done by developing and applying a comparative static, multi-commodity, partial equilibrium model with multi-stages of production function for the Malaysian perennial crops subsector which explicitly links different stages of production, primary and intermediate input markets, trade, and policy linkages. Results partly suggest that export of cooking oil will increase by 0.2 per cent due to a 10 per cent cooking oil subsidy reduction, while domestic output of cooking oil may eventually see a net decline of 1.97 per cent. The results clearly point out that the effect of reducing cooking oil subsidies is relatively small at the upstream levels and therefore it only induces minute effects on factor markets. Consequently, the market for other agricultural crops is projected to change very marginally.   Keywords: Multicomodity, comparative statics, partial equilibrium model, output supply-factor markets linkages, effects of cooking oil subsidy removals.

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