Just Answers - Real Estate

If you are planning on building a home in Central Texas, do you know what to look for when looking for a lot? The cost of the lot may be more than you think it is. I’m not talking

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

about the actual cost to purchase the lot, but what additional costs there may be when building. You need to know what to look for when buying a lot.

The first things to look for i

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

Examples of combination products may in

terms of buying a lot should be fairly obvious, but they are not to people who have not built before. Does the lot have a source of water and sewer? If the lot does not have these

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

things, the home may need a water well and septic system, both of which can be expensive. If there is water, but not sewer, a septic system will be needed. If a septic system is ne

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

ded, what kind of footprint is available for the house when you consider the septic tank and drain field location. Or if you know where you want to place the house, how expensive wi

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

Combination pro

l it be to install the septic system in the space that is left?

Another thing that may be obvious is the slope of the lot. In the Hill Country it is rare to find a lot with a perfe

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

tly level area on which to build. There may be significant excavation and or fill to do in order to prepare the land for the foundation. Concrete pours are generally charged by the

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

square foot. Usually, any thickness over three feet will incur an additional cost per foot of height. The slope might not look like much, but even a gentle slope can add up.

One

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

f the less obvious things to look for is the elevation of the lot compared to the road if sewer is available. If the house will be below the grade of the road, a grinder pump will b

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

needed in order to lift the waste water and sewage material to the level of the pipes at the street. A grinder can add to the cost of building.

Another thing to look for, that you

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

can’t really see, is the plasticity index (PI) of the soil. The PI is a measure of ground expansion and contraction when the soil is wet or dry. Much of the Central Texas Hill Coun

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

Following aspects would a

ry is made up of limestone and generally has a low PI, but there are areas of clay and sand that have a much higher PI. Land with a high PI will require additional reinforcing of th

dd to the challenges in developing combination products:

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

foundation, meaning additional steel rebar or extra thick steel. This can add to the cost of the foundation.

What about water drainage on the land? Any water that flows toward th

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

house will need to be diverted away from the foundation. Depending on the topography of the lot and the location of the house, this can add some costs. If you have the money and c

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

reativity, consider turning challenge this into a water feature.

Look at the trees on the lot. Most people love oak trees. They are slow-growing, last a long time, don’t easily sp

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

it or have branches fall in strong storms and provide great shade. You generally don’t want to remove many oaks, especially if they are large. If there are some good oaks, you may

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

Professional from academic institutions, pharmaceutical industries, health care indust

ant to build the house around them. This can present design challenges and construction challenges that translate into additional costs. The other thing about trees is that you wil

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

want to clear anything you don’t want to keep. Some lot owners clear most of the unwanted trees in order to show prospective buyers what the lot really looks like. If not, there w

.

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

ll be another small cost.

Of course there is more comparing lot cost to build cost, but this is a good start. The best thing to do when you see a lot you like is to have your REALT

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

Companies that provide selfless information through particip

R find a good builder to come out and look over the lot. A builder should be able to tell you what kind of costs you may incur when looking at the lot and the home you want to build

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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He who asks questions is attempting to be in control. That fact can be observed in any dialog. Asking questions directs the responses, and directs the dialog. Questioning can take one of three forms:

As both the European Union and the Office of the United States Trade Representative have urged that Article 39.3 of the TRIPS Agreement established an exclusivity obligation for member countries and all that is left to member countries is the determination of the duration thereof, what are the implications for India and its pharmaceutical industry which, over the years, has provided access to affordable drugs and medicine for its populace

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