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Article
Peer-Review Record

Developing a System Dynamic Model for Product Life Cycle Management of Generic Pharmaceutical Products: Its Relation with Open Innovation

J. Open Innov. Technol. Mark. Complex. 2022, 8(1), 14; https://doi.org/10.3390/joitmc8010014
by Atefeh Mousavi 1, Mehdi Mohammadzadeh 1 and Hossein Zare 2,3,*
Reviewer 1: Anonymous
Reviewer 2: Anonymous
J. Open Innov. Technol. Mark. Complex. 2022, 8(1), 14; https://doi.org/10.3390/joitmc8010014
Submission received: 12 November 2021 / Revised: 4 January 2022 / Accepted: 4 January 2022 / Published: 6 January 2022

Round 1

Reviewer 1 Report

A comprehensive study that can be used as a guide to be followed in other countries and pharmaceutical companies. It gives insights that improve the sustainability of pharmaceutical companies’ products in the market. Avoiding the decline phase of PLC is an important and challengeable outcome of the study of all manufacturers and companies to avoid it and assure maintaining their market share.

The main question is: The authors studied generic product as they mentioned in their title, but they used to trade/brand product Valsartan 80 as a model drug… not one product So how we can test Loyalty of different products of Valsartan from different companies???

Is the study conducted from 2002-2019   or 2012-2019….and in other sections of the manuscript (line 233) 2012-2021? Throughout the text, there are many different dates and periods???

Figure 3 (2012- 2022)???...we are in 2021. In addition Figure 5 (2012-2020)..not matched with the text 2018 to 2019 (line 297).

Figures 3,4, 5, and 6 are not clear with low resolution….check the Y-axis titles and scale (example: Figure 3 C)…there are many typing mistakes…also revise X-axis scale.

Background of the study:

Line 94…Where are mathematical equations used ??

Line 129…reference 25….Not available…please summarize its main results and available biography link.

Also, the authors mentioned these limitations in conclusion Line 402, So are these data reliable and accurate to be used ???

Why Valsartan 80…from 527 products ???

Line 156… 10 year period…please clarify start and end dates and checkpoints to apply statistical analysis and valuable comparison.

Line 184..Were six experts enough to confirm final relationships between variables?

Figure 2… I think total consumption of drug A has a negative effect on the consumption of imported competitors ( the authors add + sign).

The authors missed the patient loop in SD model figure 2.

System boundaries black boxes…please clarify their positions…I get only 2 boxes and their location is not between systems.

Line 247 (0.15)…is that percent….in addition please revise 4% increase…I think it is about 5%???

Subsystems of demand …please match dates with original study time periods.

 

Author Response

Dear Reviewers,

We thank you for your most valuable comments and appreciate having had this wonderful opportunity to learn from you. We hope that our responses have effectively addressed your comments.

Please see the attached file.

Thank you

Author Response File: Author Response.pdf

Reviewer 2 Report

The authors used a system dynamic model to identify the behaviors of demand, supply, and competition as three major subsystems of PLC in generic pharmaceutical products to observe the factors and impact of whole system. However, there are some parts needed to revise or explain as follow.

  1. The purpose of establishing the system dynamic architecture is unclear. The main purpose of the research needs to be clearly defined, and what kind of problems are hoped to be solved through the system dynamics. 
  2. The Background part should be merged into Introduction. At the same time, the steps and instructions of SD are not part of the background, they should be explained before the analysis. 
  3. The actual literature discussion is quite scarce, and it is not enough to compare with the previous articles and cite the differences. 
  4. In the Materials and Methods section, please explain the detailed steps and reasons for the establishment of system dynamics. Each factor and relevance of system dynamics needs to be supported by literature and reasons, otherwise it is difficult to verify. 
  5. The background description of the PLC is more like the background and description of the problem, and the placement position should be adjusted. 
  6. Almost every picture in this article is unclear and unrecognizable and needs to be significantly improved. 
  7. The results of system dynamic simulation need to clearly explain the relationship between each other, this part is completely unclear. 

On the whole, this article lacks the core of the problem. I don't know the purpose of the system dynamics and the problem it wants to solve? The rewriting of the overall article structure should be considered to strengthen the core of the problem. 

Author Response

Dear Reviewer,

We thank you for your most valuable comments and appreciate having had this wonderful opportunity to learn from you. We hope that our responses have effectively addressed your comments.

Please see the attached file.

Thank you

Author Response File: Author Response.pdf

Round 2

Reviewer 1 Report

Many thanks for the author's response and detailed information....

Author Response

Dear Reviewer,

 

We thank you for the opportunity to review the manuscript and for your most valuable comments and appreciate having had this excellent opportunity to learn from you. We hope that our responses have effectively addressed your comments.

 

Reviewer 1

Comment 1: Many thanks for the author's response and detailed information.

 

Response 1: We thank the reviewer for the nice words and the valuable comments that helped improve our work quality. We have edited the manuscript one more time to address the reviewer's statement regarding the English language. Please see the manuscript's track changes (TC) version for our modifications.

Author Response File: Author Response.pdf

Reviewer 2 Report

Compared with the previous version, the explanation of the problem has been significantly improved. Although I think there is still room for improvement in the interpretation of the results and methods. However, I still hope that the authors can revise the description again and give a clear explanation of the source of establishment of the system dynamic. If possible, the research has contributed. 

Author Response

Dear Reviewer,

 

We thank you for the opportunity to review the manuscript and for your most valuable comments and appreciate having had this excellent opportunity to learn from you. We hope that our responses have effectively addressed your comments.

  

Reviewer 2

Comment 1: Compared with the previous version, the explanation of the problem has been significantly improved. Although I think there is still room for improvement in the interpretation of the results and methods. However, I still hope that the authors can revise the description again and give a clear explanation of the source of the establishment of the system dynamic. If possible, the research has contributed. 

Response 1We thank the reviewer for the valuable comments on the first and 2nd rounds of the review that helped us improve our work quality. Here are the main modifications to this new revision.

Introduction: We have modified the introduction to emphasize the importance of the SD. Please see pages two and three.

Method: We have added a new appendix to describe the steps we have followed in this study, please Appendix 1 on page 17. We also organized the method section and modified that slightly to address the reviewers' comments. You will find our changes in the manuscript's track changes (TC) version.

Results. We added a few sentences and edited the text, and you will find the new add paragraph on page 6. Kindly see the TC version for more details.

 

Discussion and conclusion: We slightly modified the discussion section; please see changes on pages 11, 12, and 13.

English language: We edited the entire manuscript to improve the English language; please see the TC version of the manuscript for our modifications.

Author Response File: Author Response.pdf

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