3

From an EMA guideline:

The primary objective of the pharmacokinetic studies performed to support a MAA for a biosimilar is to show comparability in pharmacokinetics of the biosimilar with the reference medicinal product in a sufficiently sensitive and homogeneous population. This is expected to reduce variability, and thus the sample size needed to prove equivalence, and can simplify interpretation.

Can we omit the definite article here? Clearly the word "studies" here does not refer to specific studies.

  • I would leave it in. I would say that the "the" helps us differentiate between "studies performed" and studies which have not been performed. – Teacher KSHuang Jan 19 '17 at 9:26
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    And I would omit the :) Had it said "...studies that have been performed...was to show" instead of "studies performed...is to show", I would keep the. The primary purpose of traffic lights installed at intersections is to prevent collisions. vs The primary purpose of the traffic lights that have been installed along Route 6 was to allow traffic to exit the mall parking lot – Tᴚoɯɐuo Jan 19 '17 at 10:28
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    However, in the author's mind, or above in the text, there may have been the idea of several types of studies, and he is referring here specifically to the pharmacokinetic type of test and the objective of tests of that type. That might license the but it would still be unnecessary when speaking of generalities (cf. "traffic lights at intersections"). – Tᴚoɯɐuo Jan 19 '17 at 10:37
  • It's probably worth noting that the person or people involved in writing the document may not have been native English speakers, and some of the document may have been translated to English from another language. There is line in the document that reads: The comparison of the pharmacokinetic properties of the biosimilar product and the reference medicinal product forms normally the first step of a biosimilar mAb development. Two parts of that sound incredibly awkward ("forms normally" and "of a biosimilar mAb development") and probably were not written by a native English speaker. – user48167 Jan 24 '17 at 20:17
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+100

The definite article can most certainly be omitted in this situation, but it does not really matter one way or the other.

The paragraph immediately preceding the passage we are discussing is intended to serve as an introduction to the general topic of pharmacokinetic studies. (The whole of chapter 5 of the document deals with clinical studies. Section 5.1 introduces pharmacokinetic clinical studies, stating that conducting pharmacokinetic studies is "normally the first step" in the clinical studies part of development that the whole document addresses, while section 5.2 deals with pharmacodynamic clinial studies and section 5.3 deals with safety evaluations in clinical studies. The passage we are discussing, subsection 5.1.1, addresses the design of pharmacokinetic studies.)

The writer is using the definite article here as a way to say to the reader, "Hey, we are now going to continue discussing those pharmacokinetic studies that I said are usually the first step in development." This is a perfectly acceptable rhetorical choice.

However, using the definite article in this way is entirely optional. It does not make the meaning of the passage any clearer, within the context of the document as a whole. The "the" can be left in, or it can be removed; it simply does not really matter.

1

The primary objective of the pharmacokinetic studies performed to support an MAA for a biosimilar is to show comparability...

I think it can work either way, and it depends on how the studies are perceived as TRomano mentioned in a comment.

Regardless of whether the article is omitted or added, all pharmacokinetic studies performed to support an MAA have the same primary objective. If the definite article is used, I assume there are always some pharmacokinetic studies performed to support an MAA. If the article is omitted it's a little less certain that the studies are always pharmacokinetic studies. It seems more like the pharmacokinetic studies are just one type of several, so sometimes pharmacokinetic studies may not be performed. That may be because I'm unfamiliar with the topic though.

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