Into the Market : Launch

2014 ◽  
pp. 316-353
Keyword(s):  
Market Launch

505(b) (2) - A smart pathway to differentiate from competitive, low margin environment of generics

2021 ◽  
pp. 174113432098786
Author(s):  
Pooja Rathee ◽  
Swagat Tripathy ◽  
Sahil Khatter ◽  
BP Patra ◽  
PN Murthy ◽  
...  
Keyword(s):  
Clinical Studies ◽  
Lower Cost ◽  
Development Program ◽  
New Product ◽  
Potential Productivity ◽  
Defense Strategies ◽  
Market Launch ◽  
Regulatory Strategy ◽  
Limited Change ◽  
Early Market

Purpose 505(b) (2) application is one of the advantageous ways of regulatory submission. This submission approach can lead to fast-track approval for wide-ranging products, exclusively for those that exemplify a limited change from formerly approved drug. Safety and efficacy evidence in terms of non-clinical and clinical portion of the Reference Listed Drug (RLD), are trusted upon. Additionally, supplementary data essentially required to establish comparability with the RLD, are presented in the dossier. Methods This retrospective analysis is to understand the FDA's expectations and avoid errors in terms of data support approval for a new product submitted under the 505 (b) (2) route. The current script is an analysis on how to architect 505(b) (2) regulatory strategy by developing a different set of documents/information. Results The ultimate goal of this review is to allow drug developers to easily navigate through various 505 (b) (2) submissions and defense strategies for registration processes available to the new drug manufacturers and to understand an effective, safer filing route by facilitating early market launch with a prospect of lower cost. Conclusion Before considering option 505 (b) (2), general companies should have a good understanding of product’s potential productivity, scalability, patent infringement, expensive clinical studies and/or non-clinical studies to appropriately strategize scientific and commercial opportunities. This leverage will potentially quicken the development program and will definitely lower the clinical and regulatory risk of new product entrants.

scholarly journals A Cross-Cultural Comparison Of Factors Influencing Self-Scan Checkout Use

2010 ◽  
Vol 8 (10) ◽  
Author(s):  
Jana Schliewe ◽  
Kerstin Pezoldt
Keyword(s):  
Self Efficacy ◽  
Transition Economy ◽  
Social Pressure ◽  
Cross Cultural ◽  
Cultural Comparison ◽  
East European ◽  
Cross Cultural Comparison ◽  
Factors Influencing ◽  
Market Launch ◽  
Technology Anxiety

<p class="MsoNormal" style="text-align: justify; line-height: normal; margin: 0in 0.5in 0pt; mso-pagination: none;"><span style="font-family: &quot;Times New Roman&quot;,&quot;serif&quot;; color: black; font-size: 10pt; mso-ansi-language: EN-GB; mso-themecolor: text1;" lang="EN-GB">The purpose of this paper is to study the factors influencing the acceptance of self-scan checkouts in Russia, an emerging East European transition economy, and Germany, an established Western European market. In particular, the paper seeks to examine the potential effects of social pressure, self-efficacy and technology anxiety on the self-scan checkout usage decision. Additionally, the article attempts to find out whether firms need to adapt their strategies of market launch to the special needs of the different countries. The design of this study was empirical. Data were collected from students in two universities in Germany and Russia. The findings of the study clearly show the differences between the two countries. The German participants have a lower level of social pressure and technology anxiety whereas the Russian participants have a lower level of self-efficacy. </span></p>

Market Launch of Smart Services

2020 ◽  
pp. 89-105
Author(s):  
Tobias Leiting ◽  
Maximilian Schacht ◽  
Jana Frank
Keyword(s):  
Smart Services ◽  
Market Launch

scholarly journals Sustainable drug prices at market launch: Policy proposals and their empirical evidence

2019 ◽  
Vol 30 ◽  
pp. v680
Author(s):  
N. Fanzen ◽  
W. van Harten ◽  
V. Retel ◽  
W. Schats
Keyword(s):  
Empirical Evidence ◽  
Drug Prices ◽  
Market Launch ◽  
Policy Proposals

Deliberate Product Definition: Customizing the Product Definition Process

1997 ◽  
Vol 34 (2) ◽  
pp. 276-285 ◽  
Author(s):  
G. Kalyanaram ◽  
V. Krishnan
Keyword(s):  
Simple Model ◽  
Product Development ◽  
Development Process ◽  
Product Development Process ◽  
Just In Time ◽  
Customer Preferences ◽  
Market Launch ◽  
Alternative Approach ◽  
Product Specifications ◽  
Product Definition

The process of product definition, during which a firm establishes the product specifications, has a vital influence on the success of a product but has attracted little attention from researchers. Conventional wisdom stipulates that a firm should finalize its specifications early in the product development process. However, in industries facing rapid technological change, stiff competition, and uncertain customer needs, specifications set too early could become outdated by the time of market launch, thereby decreasing the product's benefits to the customer. The authors discuss an alternative approach, in which a firm delays commitment to product specifications and finalizes them just in time for the market launch after careful deliberation, thereby benefiting from the evolution of core technologies and customer preferences. Because such an approach introduces new managerial challenges, it would be appropriate only under certain circumstances. The authors develop a simple model of the product definition process that offers insights about how a firm should customize the process to suit its needs. They capture these insights as a managerial framework and illustrate them with industry examples involving the development process for laser printers and network test kits.

The Research on Computer Aided Design Combined with Product Design

2014 ◽  
Vol 494-495 ◽  
pp. 358-364
Author(s):  
Wei Tian
Keyword(s):  
Product Design ◽  
Data Reduction ◽  
Computer Aided Design ◽  
Market Research ◽  
Industrial Design ◽  
Market Launch ◽  
Computer Aided ◽  
Aided Design

Industrial design is an emerging edge science, which intersperses throughout the development, production and sales of product. From market research to data reduction and then to the final market launch, every segment permeates computer aided design, which will develop towards to digitization, networked, virtualization, intelligent inevitably.

scholarly journals Verifying dynamic Kano’s model to support new product/service development

2018 ◽  
Vol 11 (3) ◽  
pp. 569 ◽  
Author(s):  
Yuri Borgianni
Keyword(s):  
Customer Satisfaction ◽  
Product Development ◽  
Service Development ◽  
Customer Preferences ◽  
Empirically Supported ◽  
Market Launch ◽  
Product Service ◽  
Kano’S Model ◽  
Definition Of ◽  
Quantitative Indicators

Purpose: Although firms try to shorten time-to-market, the duration of product development projects might anyway jeopardize the assumptions made at the beginning of the design process. This includes the definition of product attributes for ensuring customer satisfaction, thus forecasting techniques could be worthwhile. Within Kano’s method, trajectories of quality attributes have been identified and they can be potentially useful to the scope, but they have not been carefully verified.Design/methodology/approach: The paper takes on the above verification challenge by exploring studies of customer satisfaction conducted by means of Kano’s model regarding manifold industrial fields. The paper focuses on changes in the relevance of customer requirements reported in different contributions and analyses data statistically.Findings: The dynamic trajectories outlined in Kano’s model are partially confirmed and they are valuable in the mid-term to predict changes in customer preferences. The use of quantitative indicators portraying the extent of customer satisfaction and dissatisfaction leads to more reliable predictions.Research limitations/implications: In order to use as many data as possible, information has been used from different industrial fields, which can exhibit different paces in changes of customer preferences.Practical implications: The results benefit firms willing to have a clearer picture of customer main drivers for customer satisfaction at the time of market launch, although customer surveys are conducted at the beginning of product development projects.Originality/value: The paper puts into question previous assumptions about modifications of customer preferences, which, however are just empirically supported and assesses how these can be exploited in a reliable way.

scholarly journals Steady Increase In Prices For Oral Anticancer Drugs After Market Launch Suggests A Lack Of Competitive Pressure

2016 ◽  
Vol 35 (5) ◽  
pp. 805-812 ◽  
Author(s):  
Caroline S. Bennette ◽  
Catherine Richards ◽  
Sean D. Sullivan ◽  
Scott D. Ramsey
Keyword(s):  
Anticancer Drugs ◽  
Steady Increase ◽  
Competitive Pressure ◽  
Market Launch
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