I Suggest - Automotive

What you’ll need:

Tools Required
-Axle Stands (?20 approx per set)
-Socket Set (?50 for an adequate set)
-Oil Funnel (Any motor-factors, ?8)
-Rag cloths
-M

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

etal Oil Drain Pan (Again any motor factors, ensure you have this placed accurately before draining the oil)
-Fresh Oil (?16, will vary with quantity and quality of oil)
-So

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

Examples of combination products may in

e Common Sense in relation to car mechanics!

Prior to attempting an oil change, you must ensure that you have the appropriate tools (as listed above), which prove essential for pe

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

rforming the task successfully. You will need to invest in a set of Axle Stands, a socket set and oil drain pan.

Preparation and Safety:

• Starting your cars engine before d

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

aining oil is advisable. Warm oil will drain faster than cold oil, so let the engine run for ten minutes before progressing to drain the old oil.
• Make sure you have placed the

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

Combination pro

car on a level surface. Engage the handbrake and get to work!
• When parked, ensure the car is supported securely, prior to crawling beneath the chassis. Do not attempt to start

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

n oil change without secure support. After jacking the car up, place two Axle stands at the front to prevent the car moving.
• Make sure to consult your owner's manual or an autom

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

otive parts specialist to find out the weight of oil which caters to your cars requirements. Quantity of oil required will vary with differing cars and engines. Quality will rely on yo

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

; do you want to buy fully or semi-synthetic oil? Obviously expect to pay more for fully synthetic popular brand names.
• Always handle hot automotive oil with extreme caution, (

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

wear appropriate gloves to remove plugs and basins by hand).
Draining old oil:
• Locate the oil plug for draining oil on the underside of the engine, which is usually to the

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

ront centre of your car. If you cannot find its location, consult your owner’s manual. Once found place your oil pan/basin underneath the plug. Loosen the plug anticlockwise with a soc

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

Following aspects would a

et wrench, and remove by hand.
• The oil will drain into the basin, whilst this is happening hold onto the oil plug.
• Once the oil finishes draining, wipe off the oil plug

dd to the challenges in developing combination products:

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

with a cloth and the surrounding area before replacing the drain plug gasket. You can opt to replace the old gasket, though we advise you change it every time you perform an oil change

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

br> • Once fitted reinstall the drain plug slowly.
• Tighten with a wrench or socket. Be careful not to over tighten the plug, which may result in threading of the bolt head.

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

>

Replacing with fresh oil:
• Remove the oil filler cap on top of the engine (underneath the bonnet).
• Now place a funnel where the opening lies and pour in your new oil (3

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

litres approx, again check your workshop manual which will of course vary with engine size and type!). Once finished put the cap back on.
• Having poured in the new oil, start you

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

Professional from academic institutions, pharmaceutical industries, health care indust

r car and let the engine run for around one minute. Stop the engine, check your oil dipstick (in close proximity to the oil filler cap) and add more oil if necessary.
• Once leve

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

is perfect, check around the oil drain plug for leaks. Wipe away excess oil with old cloths and take one last run around the oil drain plug area.
• Dispose of the old oil by pla

.

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

cing in a plastic container and bringing to an appropriate disposal location (Motor garage, recycling area), do not just throw away!

Make sure to record the mileage at which you

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

Companies that provide selfless information through particip

hanged the oil, so for future reference you will know when the car is due another change. The universal figure for recommended change of oil is around ten thousand miles. Safe motoring

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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