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Items needed to prepare your salmon and steelhead for smoking: rock salt, pepper, white sugar, paper towels, newspaper, non-stick spray, large plastic tray or plastic bucket, smoker and Alder chips.

1. Filet the salmon or steelhead on

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

both sides of backbone from the head to the tail, then cut the filet into chunks about 3 to 4 inches wide.

2. Wash the chunks in cold water and place a layer of the washed chunks in the bottom of the large plastic tray or plastic buc

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

Examples of combination products may in

et. Cover this layer with rock salt, add another layer of the fish chunks and cover this layer with rock salt. Continue doing this with the rest of your salmon or steelhead chunks.

3. Let the chunks remain in the rock salt for about

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

60 to 90 minutes, the thinner pieces for 60 minutes, and the thicker pieces 90 minutes. After the salting time is up remove the chunks from tray or bucket and thoroughly wash off the salt in cold running water.

4. On a table or count

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

er top spread out newspaper 4 or 5 sheets thick and then cover with a layer of white paper towels. Place the washed fish chunks on the paper towels skin side down. Sprinkle with small amounts of pepper and sugar. Allow the chunks to

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

Combination pro

sit about 4 hours. Spray the smoker racks with non-stick to prevent sticking during the smoking process. Place all the thicker chunks on one or two racks and the thinner chunks on the other racks and place the racks back on the paper

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

to remain drying over night. This allows a glaze to form on the fish that is necessary for proper smoking.

5. Place the smoker on a cement pad or patio blocks in an outside location where it is not affected by cold temperatures, wind

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

or rain. Do not place smoker on any type of a wooden base. Preheat the smoker with a pan of Alder chips for about one hour and then load the smoker. Place the racks with the thicker chunks in the bottom slots of the smoker and the

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

acks with thinner chunks on the top slots of the smoker. Leave a small space between the fish chunks to allow the smoke to pass and smoke all sides of the chunks.

6. Add fresh Alder chips. After one hour remove the chip pan discard

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

shes and add more chips. This will need to be done every hour, four or five times during the smoking process.

7. After 4 or 5 hours, check the fish to see how it is doing. The chunks should be drying out on top and turning a golden

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

ark red color. If not, add another pan of Alder chips and smoke for another hour. You can check for complete smoking by using a fork to open up one of the thicker fish chunks, the meat should be the same lighter color all the way thr

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

Following aspects would a

ough and the outside should have a nice golden red color. On warmer days you may only need about 4 to 5 pan of chips to complete the smoking process. During colder weather it may take up to 7 hours or longer to complete the smoking p

dd to the challenges in developing combination products:

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

ocess but try to only use 6 pans of Alder chips. If you use too many pans of Alder chips the fish tends to get a very smokey taste

8. Tips and tricks on hot smoking: (1) To get a good hot smoke cure of the fish, the temperature insid

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

the smoker needs to reach approximately 125 degrees Fahrenheit. Use a meat thermometer inside the smoker to check the temperature. Use gloves or a hot pad to remove the hot top lid of the smoker. If you find that your smoker is not r

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

eaching the proper temperature, you can easily make a box to enclose the smoker that will hold in the heat and raise the temperature. Go to a building supply store and purchase a piece of 4x8x1/2 inch thick styrofoam insulation board

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

ith aluminum foil on both sides. The insulation board is inexpensive, lightweight and easy to cut with a sharp knife.

The sides of the box can be held together with duct tape. Allow 2” spacing between smoker and the sides and the to

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

Professional from academic institutions, pharmaceutical industries, health care indust

of the styrofoam box. Cut out an opening at the bottom of the box for the smoker chip pan. The top piece of the box can be held in place with a small rock or brick. (2) Always use approved electrical extension cords when using the s

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

moker. (3) The fish on the bottom racks will smoke faster than the fish on the top racks, so you may need to remove the fish on the bottom if they are ready. Continue smoking the fish on the top racks. (4) When you first take the fish

.

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

out of the smoker, do a taste test with some white wine, cheese and crackers; this is when smoked salmon is at its best. (5) If you want to freeze your smoked fish use a vacuum packer. Place two or three of the chunks in vacuum packer

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

Companies that provide selfless information through particip

bags while they are still warm and vacuum seal. Place in the refrigerator for 3 or 4 days, this will help the oils and moister in the fish to permeate the meat with the smoke flavor. Freeze the bags and try to consume within 6 months

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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