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True confessions time: I love cruising because I love the life at sea, visiting foreign ports and because I believe it offers the most value for my travel dollar. What's NOT to love? Nevertheless, I know that some people are skeptical about taking a cruise. If this is you, then read on because there are some things you need to know so that you can be assured that your cruise will be

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

a success.

Cruises require some planning and exercising some common sense. Do both, and you will probably thoroughly enjoy your cruise and will want to book another one leaving ASAP. If you're not sure that you'll like the cruise ship experience, consider booking a 2-3 or 4-5 day mini-cruise. If you find that you really don't like it then you won't be out of pocket too much money, and you'

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

Examples of combination products may in

l soon be on terra firma once again. If I were concerned that I might not enjoy my first cruise, I would avoid booking anything 4 or 5 days. On the other hand, if you are certain that cruising is for you, book a week-long voyage just to be sure. After you have taken your first cruise, and have decided you love it, then you can begin making plans for your next (and longer) cruise. If

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

ou're like me, you will be anxiously awaiting your next cruise. In fact, you may not even want to get off the ship!

Inexpensive Cruising for the Novice Cruiser

Most of us work hard for our vacation dollars and don't want to waste them. If you're not sure you even want to go cruising, then it's even more important to make sure that you don't spend money unnecessarily. One way to avo

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

d paying too much for your first cruise is to bargain-hunt in newspapers or surf the net. Also, try to book early if you can because this will not only ensure a cheaper fare, but will also help you get cabin upgrades—-more value for your cruising dollar! Experienced, budget-conscious cruisers know that they can get a real bargain by cruising during the low season. However, in the Caribbean

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

Combination pro

low season just happens to be hurricane season. Consequently, if you are a novice (and skeptical) cruiser, I would recommend that you avoid hurricane season. Instead, consider one of many repositioning cruises because these also offer considerable savings over peak-season rates.

Are You An "Innie" or and "Outie"?

One of the (few?) mistakes I made on my first cruise was to allow myse

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

f to be swept away by the romance of the sea. I was convinced that I would spend a lot of time gazing out to see from behind my cabin window. I guess I would have done so if I had spent some time in my outside cabin! However, as it turned out, the only time I was in there was to sleep, wash, and change clothes. The rest of the time, I was enjoying the many amenities offered by the ship—defi

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

itely NOT in my cabin! The bottom line is this: if you're not sure about cruising AND you're on a budget, skip the outside cabin, book the inside one and SAVE your money!

Dining at Sea for the Novice Cruiser

In my opinion, one of the best things about cruising is that you can choose to be as active or as inactive as you want. No one forces you to do anything.

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

OU set your own itinerary by participating in as many (or as few) of the onboard activities as you wish.

One of those activities is—eating! You can eat from morning until night if you wish. The midnight buffet is not to be missed. However, if you're a novice cruiser, I would suggest being a little cautious about how much (and what) you eat. For the whole cruise? No way! Just wait and se

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

e how your body reacts to the motion of the sea. If you have no adverse reactions—then dive in and eat your fill! On the other hand...

Seasickness and the Novice Cruiser

Even though modern cruise ships are equipped with stabilizers that minimize the motions of ships, there are people who still do get seasick. What if you are one of them? Here's what happened to me and what I did ab

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

ut it.

I'm the sort of person who sometimes feels a little queasy while riding in cars or in certain types of seas. On the first night of my first cruise, the seas were rather rough and the motion of the ship made me feel a little uncomfortable but I took one my motion sickness pills and put on my special wrist-bands (designed to combat sea and air sickness). Another precaution I took was to

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

Following aspects would a

stay on deck and be as active as possible. Most important of all, I avoided looking down and reading. Also, I kept my eyes on the horizon. Consequently, the feeling soon subsided and I was fine. By the next day, I had my sea legs and never had to worry about it again. If you find yourself getting seasick, try doing what I did and see if it doesn't help you.

Medical Care, Travel Insuran

dd to the challenges in developing combination products:

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

e, and Novice Cruisers

Seasickness isn't the only malady that can befall the cruiser. Sometimes novice cruisers are reassured to know that onboard medical care is available if illness or injury strikes. However, many people don't realize that the medical care available on a ship is NOT free. It is NOT part of your fare. If you need medical care while on board ship, you w

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

ill have to pay extra for it. If your own medical plan doesn't provide coverage for you while you're on your cruise, you will have to pay for your own medical care from your own pocket. OUCH!!! The alternative is to have good quality travel insurance that will cover your medical, dental and other expenses in the event of illness or accident.

If you're not sure where you can get reliable, q

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

ality travel insurance, pay a visit to Travel Insurance Central (http://www.travel-insurance-central.com). That site is a source of information about travel insurance, including cruise insurance, and shows where you can get multiple quotes from a variety of reliable travel insurance companies. Once you've invested in a good travel insurance policy, you can relax on your cruise knowing that 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

accident or illness, rather than being a trip-ruining financial disaster, will instead just be an unpleasant glitch in an otherwise marvelous experience.

Visiting Foreign Ports for the Novice Cruiser

It is easy to get caught up in cruising the seas and visiting different ports of call. However, novice cruisers sometimes are not aware of this important point: while at sea, you are s

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

Professional from academic institutions, pharmaceutical industries, health care indust

bject to the rules and regulations of your cruise line, but when you hit port and go ashore, the ship has no jurisdiction over you. Neither can it offer you any protection while you're ashore. Nor can your own government! You are now in a foreign country and are subject to the laws of that nation. Consequently, it's essential to be familiar with the laws of the country you're visiting AND

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

to respect them.

A few years ago, the son of a friend of mine was not aware of that fact, and while visiting a Mexican port on a family cruise, he decided that it would be a good idea to urinate in public. Unfortunately for him, the police officers observing him didn't agree, and the chase was on!!! Since the boy was in good physical condition, he was able to outrun the cops and make it bac

.

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

onboard ship a few steps ahead of them and "disappear". This was lucky for him AND his parents, who would have had to choose between sailing away on the departing cruise liner and staying in port to bail their son out of jail! This could have been the end of a dream vacation and the beginning of a real nightmare!

Cruising is a great way to spend a vacation because once you're onboard, you

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

Companies that provide selfless information through particip

nly need to focus on one thing: having as much fun as possible. Your floating hotel takes you from one exotic destination to another, and all you have to do is be on board and leave the driving to the captain and crew! By following the suggestions I've mentioned you should enjoy a great trip, come home refreshed and relaxed, and wonder what took you so long to finally take your first cruise

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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