scholarly journals Study of exaptation evidence in clinical research for delivering pharmaceutical innovation

Revizor ◽  
2021 ◽  
Vol 24 (94) ◽  
pp. 7-16
Author(s):  
Milorad Stamenović
Keyword(s):  
Pharmaceutical Industry ◽  
Clinical Research ◽  
Phase I ◽  
Competitive Advantage ◽  
Clinical Studies ◽  
Pharmaceutical Innovation ◽  
High Potential ◽  
Current Role ◽  
Drug Reposition

Exaptation is a process that is characterized by the evolution of characteristics, its evolution for other usages, and later coopted for their current role. In the pharmaceutical industry, innovations have high potential in terms of competitive advantage and profit but are also connected with high risks associated with costs, time, and uncertainty. To minimize risks, companies frequently choose the strategy of exaptation in terms of redeveloping compounds for use in a different disease. The intention of this research is to provide analysis and quantification (measurement) of drugs that have been exaptated through the process of drug reposition. Results indicate that on level of 6098 clinical studies Phase I, we have observed a total of 659 drugs/substances (~11%) that have been used in more than one clinical research for the same or different indication showing the level of exaptation use in clinical research.

scholarly journals Assessment of clinical trials registered at clinical trial registry of India over past decade: an audit

2016 ◽  
Vol 3 (4) ◽  
pp. 238 ◽  
Author(s):  
Shruti S Bhide ◽  
Firoz Tadvi ◽  
Mitesh Maurya ◽  
Sunil Bhojne ◽  
Pragya Chandrakar
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Clinical Research ◽  
Clinical Studies ◽  
Descriptive Statistics ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Post Graduate ◽  
The Past

<p class="abstract"><strong>Background:</strong> Clinical trial registry of India (CTRI) was launched in 2007. In this audit we attempted to assess the clinical research scenario over the past decade by looking at the information about clinical studies registered at the CTRI from 2007 to 2016.</p><p class="abstract"><strong>Methods:</strong> We accessed the official website of the CTRI i.e. www.ctri.nic.in and the required information was downloaded and descriptive statistics were used.</p><p class="abstract"><strong>Results:</strong> We found that the number of studies went on increasing from 31 in 2007 to 7060 in 2016 (as on 22<sup>nd</sup> June 2016). Majority studies were of interventional in nature as compared to observational and bioavailability and bioequivalence (BABE) studies. Pharmaceutical industry sponsored studies were comparatively higher in number than any other sponsored studies. However their number went on decreasing, while increase in registration of post graduate thesis and investigator sponsored studies was observed.</p><p><strong>Conclusions:</strong> Though a decrease in Pharmaceutical industry sponsored studies was observed the overall clinical research scenario appears to have improved due to investigator initiated studies and post graduate thesis.</p>

scholarly journals In Vitro,In Vivo, and Clinical Studies of Tedizolid To Assess the Potential for Peripheral or Central Monoamine Oxidase Interactions

2013 ◽  
Vol 57 (7) ◽  
pp. 3060-3066 ◽  
Author(s):  
S. Flanagan ◽  
K. Bartizal ◽  
S. L. Minassian ◽  
E. Fang ◽  
P. Prokocimer
Keyword(s):  
Blood Pressure ◽  
Monoamine Oxidase ◽  
Clinical Research ◽  
Systolic Blood Pressure ◽  
Clinical Studies ◽  
Geometric Mean ◽  
Interaction Study ◽  
Mao B ◽  
Mao A

ABSTRACTTedizolid phosphate is a novel oxazolidinone prodrug whose active moiety, tedizolid, has improved potency against Gram-positive pathogens and pharmacokinetics, allowing once-daily administration. Given linezolid warnings for drug-drug and drug-food interactions mediated by monoamine oxidase (MAO) inhibition, including sporadic serotonergic toxicity, these studies evaluated tedizolid for potential MAO interactions.In vitro, tedizolid and linezolid were reversible inhibitors of human MAO-A and MAO-B; the 50% inhibitory concentration (IC50) for tedizolid was 8.7 μM for MAO-A and 5.7 μM for MAO-B and 46.0 and 2.1 μM, respectively, with linezolid. Tedizolid phosphate was negative in the mouse head twitch model of serotonergic activity. Two randomized placebo-controlled crossover clinical studies assessed the potential of 200 mg/day tedizolid phosphate (at steady state) to enhance pressor responses to coadministered oral tyramine or pseudoephedrine. Sensitivity to tyramine was determined by comparing the concentration of tyramine required to elicit a ≥30-mmHg increase in systolic blood pressure (TYR30) when administered with placebo versus tedizolid phosphate. The geometric mean tyramine sensitivity ratio (placebo TYR30/tedizolid phosphate TYR30) was 1.33; a ratio of ≥2 is considered clinically relevant. In the pseudoephedrine study, mean maximum systolic blood pressure was not significantly different when pseudoephedrine was coadministered with tedizolid phosphate versus placebo. In summary, tedizolid is a weak, reversible inhibitor of MAO-A and MAO-Bin vitro. Provocative testing in humans and animal models failed to uncover significant signals that would suggest potential for hypertensive or serotonergic adverse consequences at the therapeutic dose of tedizolid phosphate. Clinical studies are registered atwww.clinicaltrials.govas NCT01539473 (tyramine interaction study conducted at Covance Clinical Research Center, Evansville, IN) and NCT01577459 (pseudoephedrine interaction study conducted at Vince and Associates Clinical Research, Overland Park, KS).

scholarly journals Determinants of Merger and Acquisition: An Indian Pharmaceutical Industry Perspective

2019 ◽  
Vol 8 (2S11) ◽  
pp. 3081-3088
Keyword(s):  
Pharmaceutical Industry ◽  
Mergers And Acquisitions ◽  
Competitive Advantage ◽  
Secondary Data ◽  
Merger And Acquisition ◽  
Company Performance ◽  
Compulsory Licensing ◽  
The Impact ◽  
Negative Factors ◽  
Indian Pharmaceutical Industry

Mergers and acquisitions (M&A) have gained prominence across the globe as a way of gaining competitive advantage and boosting the profit of the companies. The Indian pharmaceutical industry has readily embraced M&As in the recent times and has witnessed a number of profitable deals materialize, while some indeed failed. The success of M&As is contingent upon a variety of factors and eventually has a bearing on how the acquiring and target companies perform. This study intended to identify the various factors that either lead to or impede M&As and to measure their impact on company performance. The factors that motivate and discourage M&As were identified and the importance of factors such as deal size and compulsory licensing requirement in M&A success was assessed and the impact of the all these factors on the performance of the companies was assessed using both primary and secondary data. The encouraging and discouraging aspects of M&A were found to impact company performance significantly, so did the deal size and compulsory licensing requirement. The findings implied that the success of M&As depends on a variety of positive and negative factors and the participating companies need to balance these factors judiciously in order to obtain realistic profits from M&As

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