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For those who have limited knowledge of DSP FIR and IIR terms may seem little bit tricky. Well FIR

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

stands for Finite Impulse Response and IIR stands for Infinite Impulse Response. Lets see what do

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

Examples of combination products may in

s it mean in popular manner.

All filters have their own characteristics. Characteristic are a res

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

ponse to a pulse applied to filters input. If we know filters response, we can easily calculate fi

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

ters amplitude and phase behaviour. So filter can be imagined as a transfer function, which gives

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

Combination pro

a certain response to input signal. In digital systems signal is sampled and each sample is cons

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

dered as a pulse. Calculation filter response becomes quite easy task.

Lets see what filter respo

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

nses can be. A pulse in filters input may cause finite number of output pulses, but can cause thou

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

ands (theoretically – infinite number of response pulses). Here we fase two therms – FIR and IIR.

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

IIR as we mentioned is finite impulse response filter, this means that such filter gives finite n

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

mber of pulses on output of filter ant filter function generally can be described as:

y[n]=x[n]*c

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

Following aspects would a

0+x[n-1]*c1...x[n-N]*cN

where y[n] is output signal at instant n, x[n] input signal at instant n,

dd to the challenges in developing combination products:

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

ck – the impulse response from 0 to N instants, N- number of samples in the pulse response. Lets

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

see what IIR response look like:

y[n]=a1*y[n-1]+a2*y[n-2]...ak*y[n-k]+b0*x[n]+b1*x[n-1]...bk*x[n

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

k]

We see, that IIR filter is a bit harder to read, because it has a feedback -what means that ou

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

tput signal y[n] is fed back to input. Naturally there is a question, so why use IIR filter if sim

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

Professional from academic institutions, pharmaceutical industries, health care indust

ler is to use FIR? One of obvious answers are, that IIR filter response can be created with few co

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

efficients comparing to FIR. So IIR requires less computing power than FIR. But in other hand FIR

.

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

ilter is easier to design, but gives flat phase response. FIR filters are also unconditionally sta

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

Companies that provide selfless information through particip

ble while IIR can be unstable if designed poorly. And in side effect can oscillation process start

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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