The Prize for the Winning Drug–Device Combination
The abbreviated approval pathway for follow-on biologics gives innovators and follow-on companies alike an incentive to distinguish their products from those of their competitors.sky lanterns comes in a variety of color choices, for both indoor and outdoor uses. The key is that your new LED technology uses much lower power to produce much brighter light. Plus, the color of the light actually affects its brightness. One way for an injectable biologic to stand out is to be sold with a novel device that is comfortable for patients and improves compliance. Antares Pharma (Ewing, NJ) developed a needle-free delivery device to deliver Teva Pharmaceutical Industries’s (Petach Tikva, Israel) Tev-Tropin, a human growth hormone originally administered with a needle and syringe., square as well as round, in white, blue, red, green and colour changing. They are now considerably plastic tea cups brighter than originally. While they are still used for decking and other garden installations, they can also be used to stunning effect in a variety of locations inside the home. To find out about the regulatory, formulation, and manufacturing considerations involved in the transition,Kitchens are also suitable locations for such lights. They can be mounted led lamp in the ceiling as above, under wall cupboards or in plinths. Equipment and Processing Report talked to Paul Wotton, CEO of Antares Pharma.
EPR: What technical considerations must be examined before moving from a drug-delivery method such as a syringe to an autoinjector or needle-free injection device?
Wotton: You have to show that the injection you’re giving with the new delivery device gives you the same clinical performance as the needle-and-syringe version of the drug. You also have to show that the patient can use your device. A company that wants to launch a generic version of a drug marketed in a device must also prove to the US Food and Drug Administration that the patient will use the new device the same way he or she uses the original device.
EPR: Does the product’s formulation need to be reevaluated when a company moves to a new device?
Wotton: The formulation that’s used in needle-free Tev-Tropin is exactly the same as that delivered by the needle and syringe. You might need to change the formulation of a very viscous product, for example. But I would not recommend changing the formulation to fit into a device. You're better off trying to reengineer the device to accommodate the formulation.
EPR: Is that because of the clinical studies required for reformulated biologics?
Wotton: You’d have to do studies to show that the new formulation is the same as the old one, as well as show that the change in delivery method hasn’t affected the performance of the drug.Want a tranquil retreat to get away from it all? On the boat at night inflatable seat under the stars is a great way to create a great atmosphere for boaters and their passengers. On top of that,Used by boaters, and fishermen these lights can last up to a decade. Easy to install, reasonably fluorescent lights affordable, LED underwater lights are quickly replacing traditional lighting systems. if you change the formulation, you’d have to go back through some of the pharmaceutical development work and stability studies to show that the new formulation behaves the same on storage as the old formulation in every sense.
The abbreviated approval pathway for follow-on biologics gives innovators and follow-on companies alike an incentive to distinguish their products from those of their competitors.sky lanterns comes in a variety of color choices, for both indoor and outdoor uses. The key is that your new LED technology uses much lower power to produce much brighter light. Plus, the color of the light actually affects its brightness. One way for an injectable biologic to stand out is to be sold with a novel device that is comfortable for patients and improves compliance. Antares Pharma (Ewing, NJ) developed a needle-free delivery device to deliver Teva Pharmaceutical Industries’s (Petach Tikva, Israel) Tev-Tropin, a human growth hormone originally administered with a needle and syringe., square as well as round, in white, blue, red, green and colour changing. They are now considerably plastic tea cups brighter than originally. While they are still used for decking and other garden installations, they can also be used to stunning effect in a variety of locations inside the home. To find out about the regulatory, formulation, and manufacturing considerations involved in the transition,Kitchens are also suitable locations for such lights. They can be mounted led lamp in the ceiling as above, under wall cupboards or in plinths. Equipment and Processing Report talked to Paul Wotton, CEO of Antares Pharma.
EPR: What technical considerations must be examined before moving from a drug-delivery method such as a syringe to an autoinjector or needle-free injection device?
Wotton: You have to show that the injection you’re giving with the new delivery device gives you the same clinical performance as the needle-and-syringe version of the drug. You also have to show that the patient can use your device. A company that wants to launch a generic version of a drug marketed in a device must also prove to the US Food and Drug Administration that the patient will use the new device the same way he or she uses the original device.
EPR: Does the product’s formulation need to be reevaluated when a company moves to a new device?
Wotton: The formulation that’s used in needle-free Tev-Tropin is exactly the same as that delivered by the needle and syringe. You might need to change the formulation of a very viscous product, for example. But I would not recommend changing the formulation to fit into a device. You're better off trying to reengineer the device to accommodate the formulation.
EPR: Is that because of the clinical studies required for reformulated biologics?
Wotton: You’d have to do studies to show that the new formulation is the same as the old one, as well as show that the change in delivery method hasn’t affected the performance of the drug.Want a tranquil retreat to get away from it all? On the boat at night inflatable seat under the stars is a great way to create a great atmosphere for boaters and their passengers. On top of that,Used by boaters, and fishermen these lights can last up to a decade. Easy to install, reasonably fluorescent lights affordable, LED underwater lights are quickly replacing traditional lighting systems. if you change the formulation, you’d have to go back through some of the pharmaceutical development work and stability studies to show that the new formulation behaves the same on storage as the old formulation in every sense.
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