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Kipungani Bay

Kipungani Bay is situated at the southerly tip of Lamu Island on the opposite side from busy Lamu Town. It is private, secluded, and extremely low key-perfect for a relaxin

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

g and romantic getaway.

A sprawling beach lounge and bar is the heart of Kipungani, It lures you with colorful cushions, low tables and swinging beds. There is a grass matting underfoot,

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

Examples of combination products may in

thatch above and wide open views of sand and water and distant green.

A freeform salt water swimming pool overlooks the ocean. As you swim you can watch dhows sail past and flocks of bi

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

rds skimming the water. The spillover weir gives the feeling that the pool and ocean are connected-especially dramatic when the sunset is reflected in both.

Fifteen spacious grass cottag

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

es rest casually under palm trees. Most are perched just above the beach with marvelous uninterrupted views. Behind these a few slightly smaller cottages have been built up on stilts. The

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

Combination pro

guest’s cottages have walls and floor made from local grass matting and a high pitched thatch roof. There are 12 king bedded rooms and three twins.

All ground level cottages have a priv

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

ate veranda facing the ocean and you can lounge here on local Funzi beds and chairs soft with colorful cushions. Behind the bedroom is a dressing area with hand wash basin and separate ro

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

oms for flush toilet and fresh water shower. The water is unheated and there is the romance of paraffin lamps at night. Most of the cottages also have electric lights serviced by a genera

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

tor.

Kipungani is an ideal place to get away from it all, to slow down and relax, to imagine you are on a deserted island. If you want to do something more active than lying on out sized

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

cushions, or watching the sunset, you have many choices. There is windsurfing, sailing and snorkeling. You can also go creek fishing or simply enjoy the parade of waders and water birder

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

and at certain times of year are treated to the spectacular Carmine Bee-eater migration. A visit to the nearby village provides an interesting perspective on local life and culture. Dhow

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

Following aspects would a

safaris to Lamu town or deep sea fishing can also be arranged

Kipungani Bay has a fleet of three boats; a fiberglass speedboat, a motor boat for snorkeling trips and creek fishing, and

dd to the challenges in developing combination products:

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

a “Cesse” canoe. A motorized Dhow can be hired. Kipungani Bay closes after Easter and reopens around beginning of July.

Munira Safari Camp

Munira safari camp is on the small and beautif

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

ul Kiwayu Island in the Lamu archipelago. It is a rustic and romantic spot. There is no electricity and water is brought to camp by donkey from fresh –water well on the island.

The views

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

are superb-as is the beach, the goggling and the food. There is a six mile almost deserted beach and spectacular coral reefs close to shore. You dine mainly on seafood-lots of fresh crab

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

and lobster.

There are four bandas to take a maximum of 15 people. The bandas are spacious and simple and made from local materials. There are makuti roofs overhead and almost everythin

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

Professional from academic institutions, pharmaceutical industries, health care indust

g else is made from palm matting. Each Banda has an ensuite shower, and there are long-drop toilets with a view.

You arrive through mangrove waterways to the Munira jetty from which you

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

can swim. It is a steep climb up to camp. On the other side there are lovely paths through sand dunes bringing you to the beach. There are dhows for “explorative” fishing expeditions, and

.

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

serious fishermen can arrange to charter a fully equipped deep-sea fishing boat.

The camp is run by Mike Kennedy and his sister, Caroline.

Getting to Munira Safari Camp

Fly to Kiwayu

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

Companies that provide selfless information through particip

mainland and you will be transferred by a cesse canoe. If one of the camp dhows is in Lamu for supplies, clients can be picked up and enjoy a picnic on the five hour trip to Kiwayu Island

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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