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Myth: Spiders are insects.

Fact: Actually, not everyone believes this. Around half of my calle

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

rs did learn in school that spiders are not insects, but I find it rather appalling that the percen

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

Examples of combination products may in

age is not higher. And how often, in mass media, we read or hear a phrase like "spiders prey on oth

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

r insects!" Anyway, spiders belong to the Class Arachnida, insects to the Class Insecta. Arachnids

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

re as distant from insects, as birds are from fish. It really is not a trivial distinction!

My

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

Combination pro

h: "Arachnid" is just a fancy name for spider.

Fact: There are eleven orders of arachnids. The

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

e include the scorpions; mites and ticks; harvestmen; pseudoscorpions; whipscorpions; solpugids; an

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

spiders. It's like the relation of beetles with insects: beetles constitute one order of insects,

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

he Coleoptera, but not all insects are beetles. Similarly, not all arachnids are spiders.

Myth

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

You can always tell a spider because it has eight legs.

Fact: Not exactly. Scorpions, harvest

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

en, ticks, and in fact all arachnids - not just spiders - have four pairs of legs. Insects have thr

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

Following aspects would a

e pairs. Also, notice that I said "four pairs" instead of "eight." The number of leg pairs (one pai

dd to the challenges in developing combination products:

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

per leg-bearing segment) is more significant than individual legs, which can be lost.

Myth: A

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

l spiders make webs.

Fact: Technically, a web is not just anything a spider makes out of silk;

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

it is a silk structure made to catch prey. Only about half of the known spider species catch prey

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

y means of webs. Others actively hunt for prey (including members of the wolf spider, jumping spide

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

Professional from academic institutions, pharmaceutical industries, health care indust

, ground spider, sac spider, lynx spider, and other spider families), or sit and wait for prey to c

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

me to them (trap door spiders, crab spiders.) others).

Hunting spiders use their silk for the

.

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

ragline (the single thread all spiders leave behind them when they walk), the egg sac, and in some

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

Companies that provide selfless information through particip

pecies, the retreat (a little silk "house" the spider rests in), all, but do not make true webs.

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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I have heard from a friend that her wedding has been postponed. It is very sad indeed to hear the news from her. There were a few exchange of emails and I learnt from her that she is a strong lady. Postponement of weddings could arise from many factors.

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