Recent comments in /f/askscience

aphilsphan t1_j2l2xuq wrote

To answer your question in the simplest way, every difference in dosage form is a separate New Drug Application (NDA) in the USA. The process is usually called a license application or Marketing Authorization elsewhere, but the processes are broadly similar. In one NDA, you could say, “we are going to offer this in 5, 10 and 20 mg capsules…” and you’d need to justify why those are the sizes.

You can reference information from one application in another. If the same impurities were in a capsule and oral liquid for a drug, and both hit the bloodstream the same way, you don’t have to repeat the tox study on the impurities.

I should point out that in the days when everything sent to an agency was on paper, forests trembled at the size of these filings. Now they are electronic and are even bigger.

6

slashdave t1_j2l1bxu wrote

Every method? No, that just wastes money.

Standard practice is to have a "target product profile" which guides development. The mode of delivery is typically established in advance. Since clinical studies are very expensive, it is normal to initially focus on one method of delivery. After initial market introduction, additional methods could be added to expand the market.

12

sciguy52 t1_j2l0fao wrote

No. If at all possible the oral route is preferable. Patients prefer this, easier to sell more etc. But the drug itself will determine the delivery route other wise. If the drug cannot be absorbed through the gut it may require injection. If this is not a life saving drug, say it is an antihistamine for example people are not going to be willing to take the time and expense for an injectable drug like that unless for some specific reason someone really needed it.

7

mcgato t1_j2kzuqp wrote

In that case, I think that pharmokinetic and pharmodynamic information is used to determine how the drug interacts with the body. As I understand, the pharmokinetics looks at how the drug gets into and around the body, which involves dissolution of pills in the digestive system or movement within the body after injection. The pharmodynamics looks at how the drug interacts in the body with the target of the drug, such as binding to receptors of interest that affect the disease of interest. So the mode of drug delivery that is developed is determined to maximize the effective drug delivery to where it is needed in the body.

1

cryptotope t1_j2kzpez wrote

There are (at least) a couple of different factors at work that can affect how clearly you can see a distant object.

The first is 'stuff' in the air. Dust, pollen, water (or ice). These can all change with the weather (and the seasons). The behavior of humidity - the amount that air can carry, and whether it condenses out - depends strongly on temperature.

The second is the air itself. Non-uniform air temperatures between you and those distant mountains affect the density of the intervening air, and result in weak, transient lensing effects. As you noted, it's the same phenomenon that results in mirages or heat shimmer--or which causes stars to 'twinkle' at night. Greater variations (and sharper gradients) in air temperature, coupled with greater turbulence in the air, make for worse seeing.

101

mcgato t1_j2kv4it wrote

Your question seems to assume that the drug is submitted to regulatory authorities for approval with no thought to how the patient will take the drug. A drug is submitted for approval for a specific mode of delivery to the patient. If the drug is developed for oral delivery using a pill, the submission is for oral delivery using a pill.

0