Tags |
|
|
Links |
|
|
Just Answers - Comments From A Book Reviewer
For the past several years I have been reviewing books for my own site, Bookpleasures.com, as well as many other sites. I am also a regular contribut
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
or to the Canadian Book Review Annual.
As editor of Bookpleasures.com, I would like to make a few comments about book reviewing and what to expect,
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
articularly from Bookpleasures.com.
Today, with the advent of the Internet, there has been a proliferation of book reviewers, whom I shall classify
Today, with the advent of the Internet, there has been a proliferation of book reviewers, whom I shall classify
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
as the good, the bad and the ugly.
Those falling into the last category are those that you have to be particularly on the look out for, as their onl
Those falling into the last category are those that you have to be particularly on the look out for, as their onl
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
interest is to receive complimentary books without bothering to review them, or if they do review them, their reviews are very short and without sub
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
tance.
On the other hand, there are many serious and excellent reviewers who devote a great deal of their time and energy in reading and writing a r
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
eview.
Sometimes, I admit, the reviews are not exactly very complimentary. However, it is to be noted that it is not the objective of a reviewer to
Sometimes, I admit, the reviews are not exactly very complimentary. However, it is to be noted that it is not the objective of a reviewer to
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
e a salesperson or a public relations representative for the author. If the criticism is constructive, a great deal can be learned from the review, p
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
rticularly if the reviewer is also an author.
From the point of view of a reviewer, what I find most annoying is receiving a book without first aski
From the point of view of a reviewer, what I find most annoying is receiving a book without first aski
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
ng me if I would accept to review it.
Bookpleasures receives on average about 10-15 email requests per week. Generally, I personally accept a few to
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
review, others, I forward onto Bookpleasures’ international team of reviewers.
In all probability, there is a 20%-30% chance that a request to revie
In all probability, there is a 20%-30% chance that a request to revie
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
will be accepted by a reviewer.
The reason why a book is not accepted is wide and varied. Many of our reviewers have a backlog that they would like
The reason why a book is not accepted is wide and varied. Many of our reviewers have a backlog that they would like
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
to clear before accepting new assignments, or the subject matter is not one that interests any of them.
What I like to see in a request is not “hyp
What I like to see in a request is not “hyp
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
” but rather a brief resum? of the contents of the book, who the author is, if the book is published by a main stream publisher or is it self-publish
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
d, and if the book is available on Amazon.
Bookpleasures also conducts e-interviews with some authors, and if the author is open to have himself or
Bookpleasures also conducts e-interviews with some authors, and if the author is open to have himself or
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
herself interviewed, please indicate.
If you are a publicist or publisher, don’t be afraid to put Bookpleasures as well as other book reviewing site
If you are a publicist or publisher, don’t be afraid to put Bookpleasures as well as other book reviewing site
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
on your emailing list. You never know when something catches our eyes. Sometimes you may be publicizing a particular book, and our reviewers will lo
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
k to your site and see something else that interests them.
As for the time frame, this all depends on the reviewer. Anywhere from one week to three
As for the time frame, this all depends on the reviewer. Anywhere from one week to three
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
months is the norm. You can ask the reviewer to give you some idea as to his or her time frame. You can also inquire as to his or her credentials. Bo
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
kpleasures does provide links to the reviewers’ site that should give you some idea as to their experience.
I do hope this is of help to some of you
I do hope this is of help to some of you
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.justanswers.org.ua/article/160296/justanswers-Comments-From-A-Book-Reviewer.html">Comments From A Book Reviewer</a>
BB link (for phorums):
[url=http://www.justanswers.org.ua/article/160296/justanswers-Comments-From-A-Book-Reviewer.html]Comments From A Book Reviewer[/url]
Related Articles:
Credit Card Debt Management - Make Your Future Safe
Bookmark it:
|