Summary - Relationships

"It will not do to leave a live dragon out of your plans if you live near one." The H

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

obbit ~ J.R.R. Tolkien

We have a very bad habit. Most often than not we make plans w

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

thout considering our men’s opinions. We assume they are attached to us when this is

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

o far from the truth. We make plans without consulting them, and then we expect them

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

o follow us. It doesn’t occur to us that they might have other plans.

The reality is

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

that we should appreciate their individuality. They may not have anything else to do

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

and may be happy to join us in our activities, or perhaps, they may have nothing to d

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

for the simple reason that they simply want to stay home and relax. So, before we ma

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

e any plans, let’s consult them first, if we want them to go along.

My friend Sue li

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

ed to be in charge of the family activities; however, she used to be disappointed bec

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

use every plan she had was never realized and she was not having any fun in life. One

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

day, she realized her husband was the culprit of that chronic disappointment because

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

he rarely wanted to join her in her plans. He always had something else to do. After

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

confronting" him, he finally told her that, as much as her ideas were good, he resent

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

d that she never once considered his likes and wants, so, unlike other men who do wha

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

the women say and then resent it forever, he decided not to accompany her. Luckily t

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

hat problem was easily resolved. Communication is certainly a blessing.

A Word of Ad

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ice Ladies: Let’s remember to ask our men whether they want to join us before we mak

.

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

any plans. It is only considerate.

Gents: If you don’t want to follow plans about w

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ich you haven’t been consulted, be nice but firm and refuse to go, if it is your wish

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.summary.org.ua/article/200245/summary-Know-Your-Man-Making-Plans.html">Know Your Man: Making Plans</a>

BB link (for phorums):
[url=http://www.summary.org.ua/article/200245/summary-Know-Your-Man-Making-Plans.html]Know Your Man: Making Plans[/url]

When you are getting started it's so hard to understand the integral role packaging has to play in marketing and selling your product. Put simply, it’s one of the most important product decisions you will have to make. There is a universe of packaging suppliers, materials and even regulations. Not to be overwhelmed, it is easy to navigate if you take it one step at a time. It is a process just like any other component in product development. They key is to know which packaging factors will influence your product’s success --or failure.

What are the bid and ask, and what do those numbers mean? One, the bid, is what you need to know when you are selling a stock. The other, the ask (or offer) is what you need to know when you're buying. But you also need to know those numbers. Here's how it works

Tags

Links

Summary - Know Your Man: Making Plans

Related Articles: