Why do we keep 5 levels in Linearity
In Linearity, Why do we keep 5 levels or 6 levels for Assay. can we keep more or less levels like 2 points like Lower and Higher.
What do we get by keeping 5 levels. Is there any guidelines about keeping a constant number of points for Linearity?
Replies to this topic (1)
2025-12-09 14:01:16
Linearity is the test uses for proof that the Material is showing response according with Concentration.
In general, Linearity is done with 5 point Linear or 6 point Linear because the more the points the greater the Integrity.
There are multiple reasons for putting 5 point Linearity as minimum :
- 1) Statistical Integrity: that means having 5 point instead of 2 points gives us easiness and true value of Linearity and mentioning that how good the points sitting in the Linear Curve.
- 2) Verifying its Linear or Non-Linear : 2 point or 3 point Linearity may have Linear but not as straight as such. The curve may be Sigmoid or parabolic sometimes. So, by putting 5 point calibration, such deviations in the Linear curve can be nullified.
- 3) Regulatory compliance: As per Regulatory guidelines like ANVISA and ICH, there must be minimum 5 point Linearity must be done as mentioned.
- 4) Reliability: The more the points, the higher the confirmation of Linearity and gives truthness of Linear curve .
So, there will be all these reasons and additional requirement of Regulatory guidelines, we must go for 5 point Linearity as minimum requirement.
Suggested Topics
Topic
Category
Users
Replies
Views
Activity
sukesh
4
620
2024-09-08 12:41:18
Murali Krishna
2
486
2024-09-14 17:44:43
Murali Krishna
1
482
2024-09-15 07:51:07
Swapnali chandrakant phadatare
3
822
2024-09-18 02:53:05
Srinivas
1
474
2024-09-28 05:37:15
Moshae Kathi
0
463
2024-09-29 13:26:39
Swapnali phadatare
3
574
2024-10-07 08:34:02
Murali Krishna
0
441
2024-10-08 13:14:35
Sonali Thorbole
2
445
2024-10-22 05:27:51
Sonali Thorbole
4
638
2024-10-22 12:23:17
Sonali Thorbole
3
483
2024-10-22 12:24:44
Sonali Thorbole
2
1275
2024-10-23 16:31:05
Nagendra
0
494
2024-10-24 16:19:39
Kesavarao
2
414
2024-11-12 06:31:29
Revanth
1
434
2024-12-01 08:09:43
Revanth
1
380
2024-12-29 17:11:31
Supriya
1
367
2025-01-10 14:53:31
Swapnali phadatare
2
555
2025-01-17 15:31:19
Swapnali phadatare
0
327
2025-01-17 15:32:36
Nikhil kaldhone
1
417
2025-01-18 06:36:52
Usrinivas
1
422
2025-01-18 12:52:31
Swapnali phadatare
3
365
2025-01-19 17:12:32
VINOD
2
347
2025-01-22 02:48:21
Swapnali phadatare
1
378
2025-01-23 17:18:15
Noel Shepherd
3
451
2025-03-03 02:53:50
Sravani
1
391
2025-03-29 07:01:34
Lohitha
2
347
2025-04-02 04:45:08
Ramesh Korlapu
1
410
2025-04-08 11:14:41
Sravani
1
344
2025-04-15 11:39:28
Harish
1
380
2025-04-16 13:45:09
Riffat shaheen
1
353
2025-05-17 07:01:19
Sukanya.pamarthi
1
446
2025-05-24 07:47:18
Swapnali phadatare
3
378
2025-07-15 03:14:50
Swapnali phadatare
3
359
2025-07-23 13:03:02
A. Narender
3
294
2025-09-29 16:53:37
Madhu Vardolu
1
251
2025-11-03 15:05:25
sravani
1
212
2025-11-03 15:10:55
Narsireddy
2
274
2025-11-03 15:35:26
Keerthana
1
261
2025-11-03 15:45:49
Swapnali chandrakant phadatare
3
237
2025-11-26 06:13:27
Narsimhareddy sama
1
255
2025-12-01 13:41:18
Malleshwari Mikkili
1
265
2025-12-08 15:53:36
Swapnali chandrakant phadatare
1
277
2026-01-06 06:41:31
swapnali.phadatare
2
372
2026-01-08 11:38:29
Tirumala
3
261
2026-01-24 17:57:34
Ganapuram Anil
3
97
2026-07-09 13:20:46