scholarly journals Longitudinal study of the impact of three major regulations on the Korean pharmaceutical industry in the last 30 years

2022 ◽  
Vol 20 (1) ◽  
Author(s):  
Seung In Um ◽  
Uy Dong Sohn ◽  
Sun-Young Jung ◽  
Seung-Hun You ◽  
Changone Kim ◽  
...  
Keyword(s):  
Pharmaceutical Industry ◽  
Patent System ◽  
Sustainable Growth ◽  
New Drugs ◽  
Regulatory Policies ◽  
Study Results ◽  
Short Period ◽  
Before And After ◽  
The Impact

Abstract Background The pharmaceutical industry is heavily regulated. Partly for this reason, new drugs generally take over 10 years from the product development stage to market entry. Although regulations affect the pharmaceutical industry over a long period, previous studies investigating the impact of new regulatory policies have usually focused on the short period before and after implementing that policy. Therefore, the purpose of this study is to examine whether and how significantly regulatory policies affect long-term innovation in the pharmaceutical industry in Korea. Methods This study focused on three significant regulatory policies: the introduction of the product patent system, changes in the Good Manufacturing Practice (GMP) system, and the Drug Expenditure Rationalization Plan (DERP). The study used interrupted time series (ITS) analysis to investigate the long-term impacts of the policies before and after implementation. Results Our results show that introducing the product patent system in 1987 significantly increased the number of Korean patent applications. The effect of the revised GMP policies was also statistically significant, both before and after implementation and between pre-emptive companies and non-pre-emptive ones. However, due to the companies' negotiations with the regulatory authorities or the regulatory system that links drug approval and price evaluation, the DERP did not significantly delay new drug registration in Korea. Conclusion This study showed that the policies of the product patent system, GMP policies, and DERP regulations have significantly encouraged pharmaceutical companies to strive to meet regulatory requirements and promote innovation in Korea. The study suggests that it is necessary for companies to pre-emptively respond to systemic changes in development and production strategies to deal with regulatory changes and achieve sustainable growth. Also, our study results indicate that since government policies motivate the innovative system of the pharmaceutical industry, governmental authorities, when formulating pharmaceutical policies, need to consider the impact on the long-term innovation of the industry.

scholarly journals Longitudinal Study on the Impact of Three Major Regulations on the Korean Pharmaceutical Industry in the Last 30 Years

2021 ◽  
Author(s):  
Seung In Um ◽  
Uy Dong Sohn ◽  
Sun-Young Jung ◽  
Seung-Hun You ◽  
Changone Kim ◽  
...  
Keyword(s):  
Pharmaceutical Industry ◽  
Regulatory Policy ◽  
Patent System ◽  
Sustainable Growth ◽  
New Drugs ◽  
Regulatory Policies ◽  
Short Period ◽  
Before And After ◽  
The Impact

Abstract Background: The pharmaceutical industry is heavily regulated. Partly for this reason, new drugs generally take over ten years to reach market entry from the product development stage. Although regulations affect the pharmaceutical industry over a long time, extant studies have usually focused on the short period before and after implementing a new regulatory policy to determine the impact of that policy. The purpose of this study is to examine whether and how significant regulatory policies affect long-term innovation in the pharmaceutical industry in Korea.Methods: This study focused on three significant regulatory policies: the product patent system, changes in the Good Manufacturing Practice (GMP) system, and the Drug Expenditure Rationalization Plan (DERP). This study used Interrupted Time Series (ITS) analysis to investigate the policies' long-term impacts before and after their implementation.Results: Our results show that the introduction of the product patent system in 1987 significantly increased the number of Korean patent applications. The revised GMP policies' effect was also statistically significant, both before and after implementation and between preemptive companies and non-preemptive ones. The DERP, however, did not significantly delay new drug registration in Korea due to companies' negotiations with the regulatory authorities or the system that links drug approval and price evaluation.Conclusion: This study showed that the policies of the product patent system, GMP policies, and DERP regulations have significantly altered the course of the pharmaceutical industry in Korea. This study suggests that it is necessary for companies to preemptively respond to systemic changes in development and production strategies to deal with regulatory changes and achieve sustainable growth. Also, this study implies that the governmental authorities need to develop a regulatory policy that links innovation and competitiveness in domestic pharmaceutical companies.

scholarly journals The Demerger Impact upon Sustainable Development of Economic Entities: Evidence from Romania

2021 ◽  
Vol 13 (15) ◽  
pp. 8316
Author(s):  
Camelia Mirela Baba ◽  
Constantin Duguleană ◽  
Marius Sorin Dincă ◽  
Liliana Duguleană ◽  
Gheorghița Dincă
Keyword(s):  
Sustainable Development ◽  
Business Strategies ◽  
The Sustainable Development ◽  
Ex Post ◽  
Before And After ◽  
Almost All ◽  
The Impact ◽  
Profitability Ratios ◽  
Positive Effect

The Covid-19 induced economic crisis has significantly affected almost all businesses from nearly every sector, causing severe financial problems, lack of cash assets, and decrease of revenues. In this context, the economic entities were forced to look for adjustment and rescue solutions of their activities. One possible solution for the recovery and reorganization of economic entities’ activities is demerger. This paper evaluates the impact of demerger upon the sustainable development of economic entities in terms of economic efficiency and financial performances. To achieve this goal, a statistical analysis of profitability ratios before and after the demerger, as well as a structural analysis of 268 demerger projects for the April 2012–April 2021 period, were performed. The results attest there are no significant differences between the ex-ante and ex-post financial performances. However, demerger seems to have a positive effect upon analyzed companies helping them to overcome economic hardships, rethink their business strategies, and continue their activity in the medium and long-term time horizon.

Impact of inquiry-based English teaching through digital applications on primary schoolchildren's reading comprehension and autonomy in pandemic situation

2021 ◽  
Vol 5 (S3) ◽  
Author(s):  
Ekaterine Pipia ◽  
Irina Chikovani
Keyword(s):  
Academic Performance ◽  
Reading Comprehension ◽  
English Language ◽  
Language Teaching ◽  
English Language Teaching ◽  
Autonomy Development ◽  
Study Results ◽  
Before And After ◽  
Quantitative Manner ◽  
The Impact

Considering the urgency of integrating technologies in the contemporary classrooms, the aim of the presented study has been shaped to outline the impact of inquiry-based English language teaching through digital applications on primary learners’ reading comprehension and autonomy development during a pandemic outbreak of COVID-19. The research context has been designed in a quantitative manner to analyze experiment results and compare control and treatment group learners’ reading comprehension and academic achievement levels as well as to measure primary schoolchildren’s level of autonomy before and after the treatment. The subjects’ autonomy level, curiosity and interest in reading through digital applications before and after the experiment have been evaluated through pre and post-experimental questionnaires. Learning processes of two experimental and two control groups were compared to create four research contexts for the study. Discrepancy between inquiry-based teaching through a digital library and a traditional way of teaching reading has been emphasized in the study results. The obtained data has been analyzed using SPSS to compare the academic performance results. The study revealed that inquiry-based English language teaching through digital applications highly enhanced the primary learners’ academic performance in reading and increased their motivation level to study independently.

scholarly journals Surgical Results of Retrograde Mastoidectomy with Primary Reconstruction of the Ear Canal and Mastoid Cavity

2015 ◽  
Vol 2015 ◽  
pp. 1-12 ◽  
Author(s):  
Chao-Yin Kuo ◽  
Bor-Rong Huang ◽  
Hsin-Chien Chen ◽  
Cheng-Ping Shih ◽  
Wei-Kang Chang ◽  
...  
Keyword(s):  
Adverse Events ◽  
Mastoid Cavity ◽  
Surgical Results ◽  
Ear Canal ◽  
Hearing Results ◽  
Hearing Gain ◽  
Before And After ◽  
Hearing Outcomes ◽  
The Impact

The aim of this study was to retrospectively review the long-term hearing results and the impact of mastoid exclusion/obliteration in patients with cholesteatoma (102 ears) who underwent retrograde tympanomastoidectomy and in whom bone chips/paté were applied as the sole materials during the procedure. In 79 ears, this was combined with ossiculoplasty in a single-stage procedure. In >71% of ears, the results of audiometric testing were monitored for more than 2 years. The results suggested there was a significant gain in hearing following surgery, with respect to the postoperative change in both air-conduction thresholds and air-bone gaps (P<0.001). Linear regression analyses of pure-tone averages at different frequencies, before and after surgery, demonstrated that patients benefitted from a postoperative hearing gain at low and middle frequencies, but their hearing often deteriorated at frequencies of 8000 Hz. As for the impact of the type of tympanoplasty on hearing outcomes, type III-interposition markedly increased hearing gain. The overall rate of postoperative adverse events was 8.8%. We conclude that reconstruction of the ear canal and mastoid via mastoid exclusion/obliteration using bone chips/paté can be considered as an alternative procedure following retrograde mastoidectomy. It gives excellent surgical results and has fewer postoperative adverse events.

New drugs for hypertension – variations on old themes

1991 ◽  
Vol 29 (6) ◽  
pp. 21-22
Keyword(s):  
Calcium Antagonists ◽  
Plasma Lipids ◽  
Arterial Disease ◽  
New Drugs ◽  
Converting Enzyme ◽  
First Line ◽  
Treatment Of Hypertension ◽  
Adrenergic Blockers ◽  
The Impact

Alpha-adrenergic blockers, calcium antagonists and some angiotensin-converting enzyme (ACE) inhibitors are now promoted as first-line drugs for the treatment of hypertension, competing with the traditional choices of β-adrenergic blockers and diuretics. The older drugs have established long-term benefits, but have some theoretical disadvantages and sometimes unwanted effects. No trials have looked at the impact of these new drugs on cardiovascular disease; studies of their efficacy have examined only immediate outcome measures such as blood pressure, and their effects on other risk factors for arterial disease such as plasma lipids. Choosing a drug for the initial treatment of hypertension has therefore become more difficult. We discuss here a new α-blocker and three recently marketed calcium antagonists.

Accrual management and the decision to sell or hold shares acquired from the exercise of employee stock options

2020 ◽  
pp. 0000-0000
Author(s):  
Thomas Smith ◽  
G. Ryan Huston ◽  
Richard M. Morton
Keyword(s):  
Stock Option ◽  
Employee Stock Options ◽  
Short Term ◽  
Post Exercise ◽  
Employee Stock Option ◽  
Holding Period ◽  
Before And After ◽  
Accrual Management ◽  
The Impact

This study extends the employee stock option literature by examining the impact of accrual management, before and after stock option exercise, on the timing of sales of shares acquired at exercise. We find evidence that accrual management prior to exercise is positively associated with the decision to quickly sell shares after exercise, facilitating a short-term exercise-and-sell strategy. Alternatively, we find that, among executives initially choosing to hold at exercise, tax incentives appear to drive both post-exercise accrual management and the timing of sale transactions. Specifically, our results suggest that executives use income-increasing accruals during the holding period to bolster their stock option gains sand then sell immediately after satisfying the minimum (twelve month) holding period for long-term capital gain treatment. These results provide context for prior research that found evidence of earnings management leading up to option exercise on the expectation of an immediate sale.

scholarly journals An introductory report on the effect of use of dextranase-containing mouthwash on oral health status of human volunteers

2020 ◽  
Vol 11 (1) ◽  
pp. 22-25
Author(s):  
Nucharee Juntarachot ◽  
Bhagavathi Sundaram Sivamaruthi ◽  
Sasithorn Sirilun ◽  
Piyachat Tongpong ◽  
Phakkharawat Sittiprapaporn ◽  
...  
Keyword(s):  
Oral Health ◽  
Sensory Evaluation ◽  
Dental Plaque ◽  
Oral Health Status ◽  
Plaque Index ◽  
Oral Diseases ◽  
Beneficial Effects ◽  
Study Results ◽  
Before And After ◽  
The Impact

Background: Dextran is a branched polysaccharide and one of the polymers, present in the biofilm matrix. The dextran plays a perilous role in dental plaque formation, which is involved in the development of some common oral diseases like dental caries. The dextran-hydrolyzing enzymes are under investigation to treat and manage the dental plaques. Aims and Objective: The present study reporting the preliminary observations on the effect of the use of dextranase-containing mouthwash (DMW) on dental plaque and oral health. Materials and Methods: DMW was prepared with food-grade dextranase, preservatives, gellingagents, and water as detailed. Four weeks of experimental design was employed in fourteen healthy volunteers. The selected volunteers were recommended to use DMW for at least twice a day. The plaque index (PI), probing depth (PD), gingival index (GI) and bleeding on probing (BOP) of the volunteer's teeth have been assessed before and after four weeks of DMW use. Results:The volunteers were insisted to use a DMW solution twice a day for four weeks. The PI, PD, GI, and BOP was measured before and after the treatment. The plaque index of the subject at baseline and after treatment was 2.22 ± 0.48, and 1.88 ± 0.50, respectively. PI was significantly reduced after the use of DMW solution for four weeks. The value of PD was 2.00 and 2.00 at baseline and after the use of DMW, respectively. The value of PD was not changed when compared to the baseline values. The sensory evaluation of DMW was performed using questionnaires. Conclusion: The preliminary study results suggested that the use of DMW solution for four weeks (twice a day) notably reduced the PI without any change in PD. However, GI and BOP values were not affected after the use of DMW. The participants, based on the sensory evaluation, accepted the prepared DMW solution. Additional detailed research on the impact of DMW on oral hygiene is needed to confirm the beneficial effects of DMW.

scholarly journals Prospective Evaluation of the Strategy of Functionally Optimized Coronary Intervention

2020 ◽  
Vol 9 (3) ◽  
Author(s):  
Barry F. Uretsky ◽  
Shiv K Agarwal ◽  
Srikanth Vallurupalli ◽  
Malek Al‐Hawwas ◽  
Rimsha Hasan ◽  
...  
Keyword(s):  
Coronary Intervention ◽  
Interquartile Range ◽  
Fractional Flow ◽  
Long Term Outcomes ◽  
Flow Reserve ◽  
Pressure Wire ◽  
Percutaneous Coronary ◽  
Before And After ◽  
The Impact

Background Long‐term outcomes after percutaneous coronary intervention (PCI) relate in part to residual ischemia in the treated vessel, as reflected by post‐PCI fractional flow reserve (FFR). The strategy of FFR after PCI and treatment of residual ischemia—known as functionally optimized coronary intervention (FCI)—may be feasible and capable of improving outcomes. Methods and Results Feasibility and results of FCI using an optical‐sensor pressure wire were prospectively evaluated in an all‐comer population with 50% to 99% lesions and ischemic FFR (≤0.80; ClinicalTrials.gov identifier NCT03227588). FCI was attempted in 250 vessels in 226 consecutive patients. The PCI success rate was 99.6% (249/250 vessels). FCI technical success—that is, FFR before and after PCI and PCI itself using the FFR wire—was 92% (230/250 vessels). Incidence of residual ischemia in the treated vessel was 36.5%. Approximately a third of these vessels (34.5%, n=29) were considered appropriate for further intervention, with FFR increasing from 0.71±0.07 to 0.81±0.06 ( P <0.001). Pressure wire pullback showed FFR ≤0.8 at distal stent edge was 7.9% and 0.7% proximal to the stent. FFR increase across the stent was larger in the ischemic than in the nonischemic group (0.06 [interquartile range: 0.04–0.08] versus 0.03 [interquartile range: 0.01–0.05]; P <0.0001) compatible with stent underexpansion as a contributor to residual ischemia. Conclusions FCI is a feasible and safe clinical strategy that identifies residual ischemia in a large proportion of patients undergoing angiographically successful PCI. Further intervention can improve ischemia. The impact of this strategy on long‐term outcomes needs further study.

scholarly journals A májfunkció romlásának rizikófaktorai sikeres vesetranszplantációt követően

2019 ◽  
Vol 160 (5) ◽  
pp. 186-190
Author(s):  
Bernadett Borda ◽  
Attila Nemes ◽  
Csaba Lengyel ◽  
Tamás Várkonyi ◽  
Ferenc Rárosi ◽  
...  
Keyword(s):  
Liver Function ◽  
Immunosuppressive Therapy ◽  
Liver Enzymes ◽  
Graft Loss ◽  
Study Results ◽  
Allograft Function ◽  
The Difference ◽  
The Impact ◽  
The Relationship

Abstract: Introduction: Increase of liver function is one of the most common complications after kidney transplantation due to the use of immunosuppressive therapy and hyperlipidemia in addition to hepatitis C virus (HCV) infection. Method: Following the selection criteria (n = 59), the study is based on applied immunosuppressive therapy, baseline data of patients, further correlation between HCV and liver function deterioration. Patients were subjected to fasting laboratory examination to monitor serum electrolytes, uric acid and albumin levels. We looked at the effects of immunosuppressive therapy on the lipids (TG, TC, HDL, LDL) and liver enzymes (GOT, GPT, ALP, GGT). The analysis of the relationship between lipids and liver enzymes was also included in our study. Results: The data basics were not significantly different between the tacrolimus and the cyclosporine groups. In the laboratory results, Mg levels were significantly different between the two groups (p = 0.044). The impact of HCV on the liver function was significantly different on GGT (p = 0.008). We examed the lipids and liver function level between the tacrolimus and the patients receiving cyclosporine-based immunosuppression and the total cholesterol (p = 0.005) and GOT (p = 0.05) were significantly different between the two groups. Hyperlipidemia was associated with 26% of patients taking tacrolimus-based immunosuppression, and 89% of those receiving cyclosporine; the difference was significant (p = 0.002). Regarding the effect of hyperlipidemia on liver enzymes, ALP (p = 0.006) and GGT (p = 0.0001) were significantly higher. Conclusion: Increases in hepatic enzymes, ALT and GGT indicate the damage to hepatocytes. Beside the increase of liver function, which is the main risk factor in hepatitis on HCV soil, the applied immunosuppressive therapy and hyperlipidemia lead to degradation of allograft function and long-term graft loss. Orv hetil. 2019; 160(5): 186–190.

Impact of Extracorporeal Photochemotherapy on the Clinical and Economical Management of Patients Affected with GVHD.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 5293-5293
Author(s):  
Cesare Perotti ◽  
Paola Isernia ◽  
Claudia Del Fante ◽  
Gianluca Viarengo ◽  
Daniela Bressan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Cost Analysis ◽  
Short Form ◽  
Extracorporeal Photochemotherapy ◽  
Short Period ◽  
The Impact ◽  
Economical Advantage

Abstract Extracorporeal photochemotherapy (ECP) is an effective, relatively new technique, FDA approved for cutaneous T-cell lymphoma, employed as second-third line treatment in patients affected with GVHD not or poorely responsive to standard immunosuppressive drugs. Both aGVHD and cGVHD are the major complications after stem cell transplantation (till to 50% and 80% of the patients, respectively). Corticosteroids, cyclosporine, micofenolate, tacrolimus and various experimental monoclonal antibodies (anti CD40 ligand, anti TNFα etc) are the drugs employed to control GVHD and are burdened with important short and long term side effects. Recently we revised our data about 102 pts (children and adults) treated by ECP in our Institution. The overall response was 75%, permitting to taper or suspend the immunosuppressive therapy (IST) in 67.6% of the pts. The economical and social impact (cost analysis and quality of life) of ECP vs standard IST was calculated basing on the National Price List and on Short Form Quality of Life (QoL) Scoring System. The cost of ECP comprehensive of the leukapheresis procedure, waste matherials and dedicated personnel was estimated as 684.51 Euro/procedure. On the other side, when the solely costs of the most common IST drugs (corticosteroids, cyclosporine) were considered for 5 months of treatment, an evident and obvious economical advantage emerged (120,3 E). On the contrary, when the costs of hospitalisation and day hospital regimen derived from the most common side effects related to the solely use of IST were included in our cost analysis studies, an economical advantage for long term ECP treatment (calculated on 16 procedures) was demonstrated (14952.16 E vs 17553 E). Moreover, when the “real life implication” calculated on the QoL parameters were considered, the advantages were more evident. In conclusion, the tie of respecting strictly an imposed program of budget calculated on the short period may exert an inhibitory effect in introducing new diagnostic or therapeutic procedures ignoring that the improvement or the cure of the patient has always a positive economical counterpart, expecially when the impact of a new technology is considered in a long term view.

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