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Advice Pool - Are You A Mardy Bum? (Part 1)
Do you find that you have times when you are being irritable with everyone around you? You know you're doing it, but f
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
ind it almost impossible to stop yourself? A lot of people in the music industry (and me too!) tell me that have days
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
when no matter how much they try to stop themselves, they are almost biting the heads off everyone around them! You to
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
o huh?
If you are not familiar with the term, 'mardy bum' - it has now been immortalised by the fantastic Arctic Monke
If you are not familiar with the term, 'mardy bum' - it has now been immortalised by the fantastic Arctic Monke
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ys' song "Mardy Bum" from their first album "Whatever People Say I Am, That's What I'm Not".
But what is a mardy bum?
But what is a mardy bum?
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
Do you display 'mardy bumness' within your music career? And how can you stop being one?
Mardy is a word that describ
Mardy is a word that describ
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
es someone who is: sulky, in a bad mood, being stroppy, grumpy, tetchy, irritable etc. They usually look as bad as 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
y feel and people will often say, "What's up with him? - he's got a right face on!" meaning that he looks really mardy.
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
Most of my clients tell me that they either display 'mardy bumness' themselves or they certainly come across others w
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
ho do! How does this manifest? Artist Managers will tell me that the artists they represent are 'difficult' and becom
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
'mardy' leading up to a live gig or before an interview, for example. Artists themselves have said they become mardy
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
before going into a studio to record or when they just feel the pressure of a huge music schedule. Unfortunately the i
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
mpact of you being mardy is that everyone around you finds it hard to talk to you and feel like they are walking on egg
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
shells around you.
Of course mardy bumness isn't confined to just artists, but extends to everyone involved in the mus
Of course mardy bumness isn't confined to just artists, but extends to everyone involved in the mus
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ic industry - managers, producers, A & R personnel, studio managers, publishers, promoters, booking agents - you name t
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
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
em, they get mardy!
However, most people don't get mardy just for the sake of it - there is usually an underlying reas
However, most people don't get mardy just for the sake of it - there is usually an underlying reas
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
on for it. So what is this mardy bumness all about? It's about your stress, your pressure, your loss of confidence, y
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ou lack of self-belief, your feelings of insecurity. The problem is, is that most people don't realise what is happeni
.
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
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
ng to them and certainly don't know how to communicate their feelings of stress etc and so it inevitably comes out thro
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ugh being mardy.
In part 2 of this article, you can see a worked example of how to work through your own mardy bumness
In part 2 of this article, you can see a worked example of how to work through your own mardy bumness
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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BB link (for phorums):
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