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Now we know about adding and multiplying, and have touched on dividing (see History of the Computer - Flip-Flops a basic counter) what about subtra

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

cting and negative numbers? Once again we take the simple way.

To form a negative number, we simply invert the positive number, in binary, and add

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

Examples of combination products may in

1. For example

0000 0110 - (6) inverted becomes
1111 1001 - now add 1 to get
1111 1010 - (-6)

This is how a compu

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

er records -6. The Most Significant Bit - in this case bit 7 or bit value 128 decimal is used as the Sign Bit. If this bit is a zero, the n

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

umber is positive, if it is a one, the number is negative. This notation is known as 'Twos Complement'.

(There is also 'Ones Compleme

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

Combination pro

t', without the added 1, which was used in some proprietary systems, but it required more complicated logic to get around problems like having + and

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

- zero. It is not necessary to go into the detail of this notation for an understanding of the logic.)

The Sign bit uses one of the bit pos

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

tions, meaning that our range of numbers is reduced. For example 0111 1111 is the highest positive 8-bit number (127 decimal). The next number, 12

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

8 decimal would be 1000 0000, however the bit value 128 in bit 7 cannot be used as it is now the sign bit.

SUBTRACTION

Now we can have a ne

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

ative number it will be easy to subtract. We can use an adder, which we already have. This is possible because 9-3 is the same as 9+(-3). For ins

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

tance 9-3 decimal is 00001001-00000011 in 8 bit binary. We take the 9 and add it to the twos complement of 3, thus we can use our adder with a bit

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

Following aspects would a

of extra logic to invert the negative number and add 1 to it. The twos complement of 3 (decimal) or in binary
of 0000 0011
is 1

dd to the challenges in developing combination products:

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

11 1100
add 1 + 0001
is 1111 1101

Now add to the 9 (decimal) using an 8 bit adder:-
7654 3210 - bit #

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

0000 1001 - (9)
1111 1101 - (-3)

Remember your binary addition?

Least significant bit (bit 0), 1+1 is 0 and a carry.

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

Next bit (bit 1) is 0+0+carry = 1 no carry.
Next bit (bit 2) is 1+0 = 1 no carry.
Next bit (bit 3) is 1+1 = 0 and a

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

carry.
Next bit (bit 4) is 1+0+carry = 0 and a carry.
Next 3 bits (5,6,7) are the same as 4 - 1+0+carry = 0. The last carry

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

Professional from academic institutions, pharmaceutical industries, health care indust

falls off the end.*

So we get:-

0000 0110 (6 Decimal - 9-3=6)

Which, fortunately, if you followed it, is the right answer! Are th

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

ese computers smart or what? This system works with negative results as well, for instance try 3-9. You should end up with the twos complement of

.

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

. This is not a compulsory exercise!

* The carry from the most significant bit, in this example bit 7, but could be bit 31 or 63 in some co

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

Companies that provide selfless information through particip

mputers, is ignored in this case. However it is used in some functions, for instance a circular bit shift, which we will look at in a later article

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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