References - Travel and Leisure

Before we take a look at whale watching, we should take a moment to get to know these magnificent animals ...

What's a Cetacean?

Cetaceans are mammals that live their entire lives in the water and

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

include whales, dolphins and porpoises. They have hair, breathe air, are warm-blooded and bear live young that drink their mother's milk.

There are two types of cetaceans: the toothed whales, whic

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

Examples of combination products may in

h (obviously) have teeth and include all porpoises and dolphins. (Dolphins and porpoises have different types of teeth: dolphins' teeth are sharp, while porpoises have flatter, shovel-shaped teeth.)

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

And the baleen whales, which have giant comb-like structures on their jaws that are used to sift food, such as shrimp-like krill, from the water. Humpbacks (that pass by my neighbourhood) and Blue

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

whales are baleen whales.

Baleen whales can eat up to 9,000 pounds of fish and krill daily. This hearty appetite is due to the fact that they don't eat all year round, usually feeding about half th

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

Combination pro

e year in the cold, nutrient-rich waters of their summer feeding grounds. They store huge amounts of fat or blubber to get them through the breeding season.

The largest whale is the Blue whale, whi

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

ch can grow up to 100 feet long and weigh up to 190 tons, and the deep-diving Sperm whale can go down 5,000 feet and stay down for more than an hour.

Whale Songs

In the late 1960s, whale biologist

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

Roger Payne discovered that humpback whales "sing" to each other and themselves. After researching this phenomenon, scientists now know that while both male and female humpbacks can produce sounds,

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

only the males appear to produce organised songs with distinct themes and melodies, and almost always on breeding grounds.

Apparently the males often sing while suspended deep below the surface, th

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

eir long front flippers jutting rigidly from their sides. The songs can last up to 20 minutes and can be heard more than 20 miles away. The male may repeat the same song dozens of times over several

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

hours and whales in the same geographic area sing in very similar "dialects." Song patterns can change gradually over time, so new songs emerge every few years.

Researchers still aren't sure exact

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

Following aspects would a

ly how the whales produce the sounds and since whales don't have vocal cords, they probably sing by circulating air through the tubes and chambers of their respiratory system. But no air escapes dur

dd to the challenges in developing combination products:

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

ng the concerts -- and their mouths don't move!

There are some theories about why the whales sing, and while scientists originally believed they were a mating call, used to advertise the male's ava

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

ilability to passing females, they've since come up with another theory. Some researchers now believe that the singing humpbacks are actually issuing threats, not singing love songs, because many of

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

the whales approaching singers were other males and the meeting would often end in a tussle.

We may never know exactly why these whales produce their songs of creaks, groans and moans.

This is an

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

excellent place to begin your acquaintance with whales and has links to sites around the globe: http://www.physics.helsinki.fi/whale/

The south-east coast of New South Wales provides one of the be

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

Professional from academic institutions, pharmaceutical industries, health care indust

t places to observe whales during their northern migration: http://www.sapphirecoast.com.au/whales/default.htm This region was once the centre of whaling operations that took hundreds of mammals e

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

ach season to be turned into oil, perfume and corsets for rich ladies! (Read about ambergris and perfume here: http://www.write101.com/W.Tips374.htm )

Queensland (the north-east coast of Australia)

.

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

has information on the behaviour and habitat of the Humpback whale (the most common whale in this part of the world): http://www.dkd.net/whales/

You can subscribe to a free newsletter that gives y

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

Companies that provide selfless information through particip

ou weekly updates of the movement of whales around the world: http://www.whales-online.org/ You'll also discover all the ways our modern way of life threatens the survival of these wonderful mammals

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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