E-Articles - Health and Fitness

The richness of our language in synonyms for depression may be taken as an indication of its frequency. It is an emotional experience, though sometimes it i

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

s described as an 'emptiness' or 'flatness', seemingly a loss rather than a lowering of mood.

Depression, like anxiety, is a universal experience and we reg

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

Examples of combination products may in

ard it as abnormal only if it appears without reason or if it seems excessive in its degree or duration in relation to the cause. Not surprisingly, such a c

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

ommon feeling may be associated with any psychiatric syndrome; the depressive orders are those in which the depressed effect appears to be the primary phenom

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

enon or at any rate one of the more prominent of the clinical features.

Broadly, there are two depressive entities - endogenous depression, which is a varia

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

Combination pro

t of manic-depressive illness and neurotic depression. In practice, the differentiation between these two conditions is often difficult, but this is not sur

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

prising when we recall that any primary psychiatric disturbance may be associated with secondary or reactive features and of these, depression is one of 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

more common. To simplify matters this relationship suggests that in any individual case, the patient is regarded as having 40 per cent endogenous and 60 per

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

cent reactive or neurotic depression. Forgetting the figures for a moment, it is the endogenous component that is important, for the remainder is a reactio

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

n to it.

Successful treatment of endogenous depression is likely to lead to total recovery, whereas treatment directed only at the reactive component can ha

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

dly be more that partly successful. The term 'atypical depression' has been applied to some of these cases. It is only in the last 15 odd years that we hav

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

Following aspects would a

e come to appreciate how common depressive illness is. It is estimated that in general practise one could expect that of every 1000 patients, 12 would prese

dd to the challenges in developing combination products:

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

nt as new cases each year. Older figures, largely hospital derived and therefore making little allowance for milder cases, suggest that the incidence of end

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

ogenous depression alone is 1% in males and 2% in females. It would be unwise to suggest that depressive illness has become more common in the last 10 years

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

; the much larger number of cases seen reflects the fact that we have learned to recognise its milder forms.

When the diagnosis of depression is made, three

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

interrelated decisions have to be made: can the patient be treated by a general practitioner or should the case be referred for specialist care, is hospital

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

Professional from academic institutions, pharmaceutical industries, health care indust

administration required or is the patient suicidal.

The great majority of cases can be treated by a general practitioner and indeed their numbers are such t

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

hat there is no alternative. Immediate referral to a consultant psychiatrist or even a psychiatric hospital is generally advisable if the patient has strong

.

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

suicidal ideas or has made a suicide attempt. Severe agitation, obvious retardation, delusionary ideas of guilt or unworthiness and severe loss of weight a

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

Companies that provide selfless information through particip

re other indications. Failure to respond to adequate doses of one of the antidepressant drugs over a period of say three weeks also makes referral advisable

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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