untitled h1
16.3 pk assay validation

| 16.3.1 LB-100 Plasma Sample Name Calculated Concentration LB-100 Day 1 Day 2   | Day 3   | Day 4   |         |         |
|--------------------------------------------------------------------------------|---------|---------|---------|---------|
| H                                                                              | 1.041   | 1.989   | 1.885   | 1.87    |
| G                                                                              | 4.458   | 4.873   | 5.084   | 5.448   |
| F                                                                              | 20.07   | 20.78   | 20.66   | 20.69   |
| E                                                                              | 40.68   | 40.99   | 41.20   | 42.32   |
| D                                                                              | 202.50  | 210.30  | 192.60  | 213.00  |
| C                                                                              | 402.90  | 401.70  | 379.60  | 404.10  |
| B                                                                              | 814.60  | 875.50  | 885.90  | 828.10  |
| A                                                                              | 957.40  | 968.20  | 938.90  | 962.70  |
| LOQ                                                                            | 0.77    | 1.97    | 2.13    | 1.85    |
| LQC                                                                            | 5.10    | 7.19    | 5.78    | 6.32    |
| MQC                                                                            | 41.23   | 39.10   | 39.51   | 41.96   |
| HQC                                                                            | 736.30  | 767.00  | 771.30  | 727.50  |
| DQC                                                                            | 5121.00 | 5205.00 | 4954.00 | 4771.00 |
| LOQ                                                                            | 2.06    | 1.94    | 1.76    | 1.90    |
| LQC                                                                            | 5.06    | 8.02    | 6.20    | 6.41    |
| MQC                                                                            | 39.66   | 40.16   | 39.30   | 40.93   |
| HQC                                                                            | 754.20  | 780.20  | 770.00  | 730.60  |
| DQC                                                                            | 4886.00 | 5244.00 | 4809.00 | 4810.00 |
| LOQ                                                                            | 1.09    | 2.03    | 2.01    | 2.22    |
| LQC                                                                            | 5.10    | 7.37    | 5.83    | 6.51    |  
| Version Date: 06/02/2022 MQC 40.00   | 40.39     | 39.98     | 38.36     |         |
|--------------------------------------|-----------|-----------|-----------|---------|
| HQC                                  | 718.90    | 791.20    | 763.20    | 709.60  |
| DQC                                  | 4890.00   | 5239.00   | 4876.00   | 5054.00 |
| LOQ                                  | 2.08      | 2.20      | 1.96      | 2.12    |
| LQC                                  | 5.38      | 7.56      | 5.90      | 6.11    |
| MQC                                  | 40.32     | 41.91     | 39.57     | 40.98   |
| HQC                                  | 743.10    | 800.90    | 766.90    | 735.40  |
| DQC                                  | 5104.00   | 5378.00   | 4840.00   | 4721.00 |
| LOQ                                  | 1.36      | 2.11      | 1.97      | 2.05    |
| LQC                                  | 5.22      | 7.60      | 6.07      | 5.86    |
| MQC                                  | 41.02     | 41.37     | 39.13     | 40.58   |
| HQC                                  | 762.80    | 775.40    | 793.70    | 775.40  |
| DQC                                  | 5005.00   | 5277.00   | 4893.00   | 4802.00 |
| H                                    | 1.93      | 2.02      | 2.07      | 2.00    |
| G                                    | 5.85      | 5.08      | 5.05      | 5.27    |
| F                                    | 21.47     | 18.98     | 21.08     | 19.71   |
| E                                    | 41.27     | 37.18     | 42.51     | 41.61   |
| D                                    | 208.20    | 212.80    | 202.40    | 199.80  |
| C                                    | 414.90    | 414.20    | 404.30    | 399.70  |
| B                                    | 848.70    | 866.70    | 885.90    | 821.80  |
| A                                    | 943.50    | 1001.00   | 974.30    | 933.20  |
| 2/18/2016                            | 2/19/2016 | 2/22/2016 | 2/23/2016 |         |
| Linearity                            | AVG       | SD        |           |         |  
| Day 1              | 0.994049   | 0.99659875   | 0.001934316   |        |        |       |      |       |       |      |      |      |    |
|--------------------|------------|--------------|---------------|--------|--------|-------|------|-------|-------|------|------|------|----|
| Day 2              | 0.998141   |              |               |        |        |       |      |       |       |      |      |      |    |
| Day 3              | 0.998061   |              |               |        |        |       |      |       |       |      |      |      |    |
| Day 4              | 0.996144   |              |               |        |        |       |      |       |       |      |      |      |    |
| Nomin al  (ng/mL ) | Day        | Da           |               |        |        |       |      |       |       |      |      |      |    |
| 1-1                | y  1-2     | Day          | Day           | Day    | Day 3- | Da    |      |       |       |      |      |      |    |
| 2-1                | 2-2        | 3-1          | 2             | y 4- 1 | Day 4- | GM    |      |       |       |      |      |      |    |
| 2                  | (ng/ mL)   | SD  (ng/ mL) | DEV           | R.S.D  | n      |       |      |       |       |      |      |      |    |
| (%)                | (%)        |              |               |        |        |       |      |       |       |      |      |      |    |
| 2                  | 1.9        | 1.9          | 2.0           | 1.8    | 2.07   | 1.8   | 2.00 | 1.97  | 0.07  | -    |      |      |    |
| 3                  | 9          | 2            | 9             | 7      | 1.68 % | 3.75  | 7    |       |       |      |      |      |    |
| %                  |            |              |               |        |        |       |      |       |       |      |      |      |    |
| 5.00               | 4.46       | 5.8          | 4.8           | 5.0    | 5.0    | 5.05  | 5.4  | 5.27  | 5.14  | 0.41 | 2.80 | 7.96 | 8  |
| 5                  | 7          | 8            | 8             | 5      | %      | %     |      |       |       |      |      |      |    |
| 20.00              | 20.0       | 21.          | 20.           | 18.    | 20.    | 21.08 | 20.  | 19.71 | 20.43 | 0.80 | 2.15 | 3.92 | 8  |
| 7                  | 47         | 78           | 98            | 66     | 69     | %     | %    |       |       |      |      |      |    |
| 40.00              | 40.6       | 41.          | 40.           | 37.    | 41.    | 42.51 | 42.  | 41.61 | 40.97 | 1.66 | 2.43 | 4.04 | 8  |
| 8                  | 27         | 99           | 18            | 20     | 32     | %     | %    |       |       |      |      |      |    |
| 200.00             | 202.       | 20           |               |        |        |       |      |       |       |      |      |      |    |
| 50                 | 8.2 0      | 210          | 212           | 192    | 202.4  | 21    |      |       |       |      |      |      |    |
| .30                | .80        | .60          | 0             | 3.0 0  | 199.80 | 205.2 | 7.14 | 2.60  | 3.48  | 8    |      |      |    |
| 0                  | %          | %            |               |        |        |       |      |       |       |      |      |      |    |
| 400.00             | 402.       | 41           |               |        |        |       |      |       |       |      |      |      |    |
| 90                 | 4.9 0      | 401          | 414           | 379    | 404.3  | 40    |      |       |       |      |      |      |    |
| .70                | .20        | .60          | 0             | 4.1 0  | 399.70 | 402.6 | 10.8 | 0.67  | 2.70  | 8    |      |      |    |
| 8                  | 8          | %            | %             |        |        |       |      |       |       |      |      |      |    |
| 900.00             | 814.       | 84           |               |        |        |       |      |       |       |      |      |      |    |
| 60                 | 8.7 0      | 875          | 866           | 885    | 885.9  | 82    |      |       |       |      |      |      |    |
| .50                | .70        | .90          | 0             | 8.1 0  | 821.80 | 853.4 | 29.1 | -     |       |      |      |      |    |
| 0                  | 4          | 5.18 %       | 3.41          | 8      |        |       |      |       |       |      |      |      |    |
| %                  |            |              |               |        |        |       |      |       |       |      |      |      |    |
| 1000.0             | 957.       | 94           |               |        |        |       |      |       |       |      |      |      |    |
| 0                  | 40         | 3.5 0        | 968           | 100    |        |       |      |       |       |      |      |      |    |
| .20                | 1.0 0      | 938          | 974.3         | 96     |        |       |      |       |       |      |      |      |    |
| .90                | 0          | 2.7 0        | 933.20        | 959.9  | 22.0   | -     |      |       |       |      |      |      |    |
| 0                  | 5          | 4.01 %       | 2.30          | 8      |        |       |      |       |       |      |      |      |    |
| %                  |            |              |               |        |        |       |      |       |       |      |      |      |    |  
| LLOQ QC   | Day 1   | Day 2   | Day 3   | Day 4   | GM   | SD          | DEV    |
|-----------|---------|---------|---------|---------|------|-------------|--------|
| 2 ng/mL   | 0.77    | 1.97    | 2.13    | 1.85    | 1.88 | 0.377066079 | -6.11% |
| 2.06      | 1.94    | 1.76    | 1.90    |         |      |             |        |
| 1.09      | 2.03    | 2.01    | 2.22    |         |      |             |        |
| 2.08      | 2.20    | 1.96    | 2.12    |         |      |             |        |
| 1.36      | 2.11    | 1.97    | 2.05    |         |      |             |        |  
| ANOVA Source of      | SS    | df   | MS      | F                 | P-value    |
|----------------------|-------|------|---------|-------------------|------------|
| Variation Between    | 1.123 | 3    | 0.3744  | F (3, 16) = 3.799 | P = 0.0313 |
| Groups Within Groups | 1.577 | 16   | 0.09855 |                   |            |
| Total                | 2.7   | 19   |         |                   |            |
| BRP                  | 12.51 |      |         |                   |            |
| WRP                  | 16.72 |      |         |                   |            |  
Low QC Day 1 Day 2 Day 3 Day 4 GM SD DEV 6 ng/mL 5.10 7.19 5.78 6.32 6.23 0.90406471 3.84%  
5.06 8.02 6.20 6.41 5.10 7.37 5.83 6.51 5.38 7.56 5.90 6.11 5.22 7.60 6.07 5.86  
| ANOVA Source of  Variation Between  Groups   |
|----------------------------------------------|  
| SS        | df    | MS    | F                 | P-value    |       |             |       |
|-----------|-------|-------|-------------------|------------|-------|-------------|-------|
| 14.66     | 3     | 4.886 | F (3, 16) = 92.41 | P < 0.0001 |       |             |       |
| BRP       | 15.78 |       |                   |            |       |             |       |
| WRP       | 3.69  |       |                   |            |       |             |       |
| Middle QC | Day 1 | Day 2 | Day 3             | Day 4      | GM    | SD          | DEV   |
| 40 ng/mL  | 41.23 | 39.10 | 39.51             | 41.96      | 40.27 | 0.977607714 | 0.68% |
| 39.66     | 40.16 | 39.30 | 40.93             |            |       |             |       |
| 40.00     | 40.39 | 39.98 | 38.36             |            |       |             |       |
| 40.32     | 41.91 | 39.57 | 40.98             |            |       |             |       |
| 41.02     | 41.37 | 39.13 | 40.58             |            |       |             |       |  
Within Groups 0.846 16 0.05287  
| ANOVA Source of  Variation   |
|------------------------------|  
Total 15.5 19 Within Groups 14.1 16 0.8811 Total 18.16 19  
| SS             | df   | MS   | F     | P-value           |            |
|----------------|------|------|-------|-------------------|------------|
| Between Groups | 4.06 | 3    | 1.353 | F (3, 16) = 1.536 | P = 0.2437 |
| BRP            | 0.76 |      |       |                   |            |  
| WRP   | 2.33   |
|-------|--------|  
754.20 780.20 770.00 730.60 718.90 791.20 763.20 709.60 743.10 800.90 766.90 735.40 762.80 775.40 793.70 775.40  
High QC Day 1 Day 2 Day 3 Day 4 GM SD DEV 800 ng/mL 736.30 767.00 771.30 727.50 758.68 25.75993625 -5.17%  
| ANOVA Source of      | SS    | df   | MS    | F                 | P-value    |
|----------------------|-------|------|-------|-------------------|------------|
| Variation Between    | 7831  | 3    | 2610  | F (3, 16) = 8.744 | P = 0.0012 |
| Groups Within Groups | 4777  | 16   | 298.5 |                   |            |
| Total                | 12608 | 19   |       |                   |            |
| BRP                  | 2.83  |      |       |                   |            |
| WRP                  | 2.28  |      |       |                   |            |  
| Dilution QC   | Day 1   | Day 2   | Day 3   | Day 4   | GM      | SD          | DEV    |
|---------------|---------|---------|---------|---------|---------|-------------|--------|
| 5000 ng/mL    | 5121    | 5205    | 4954    | 4771    | 4993.95 | 195.6991448 | -0.12% |
| 4886          | 5244    | 4809    | 4810    |         |         |             |        |
| 4890          | 5239    | 4876    | 5054    |         |         |             |        |
| 5104          | 5378    | 4840    | 4721    |         |         |             |        |  
| 5005   | 5277   | 4893   | 4802   |
|--------|--------|--------|--------|  
| ANOVA Source of          | SS    | df    | MS    | F                 | P-value    |             |        |
|--------------------------|-------|-------|-------|-------------------|------------|-------------|--------|
| Variation Between Groups | 7831  | 3     | 2610  | F (3, 16) = 8.744 | P = 0.0012 |             |        |
| Within Groups            | 4777  | 16    | 298.5 |                   |            |             |        |
| Total                    | 12608 | 19    |       |                   |            |             |        |
| BRP                      | 2.83  |       |       |                   |            |             |        |
| WRP                      | 2.28  |       |       |                   |            |             |        |
| Dilution QC              | Day 1 | Day 2 | Day 3 | Day 4             | GM         | SD          | DEV    |
| 5000 ng/mL               | 5121  | 5205  | 4954  | 4771              | 4993.95    | 195.6991448 | -0.12% |
| 4886                     | 5244  | 4809  | 4810  |                   |            |             |        |
| 4890                     | 5239  | 4876  | 5054  |                   |            |             |        |
| 5104                     | 5378  | 4840  | 4721  |                   |            |             |        |
| 5005                     | 5277  | 4893  | 4802  |                   |            |             |        |  
| ANOVA Source of      | SS     | df   | MS     | F                 | P-value    |
|----------------------|--------|------|--------|-------------------|------------|
| Variation Between    | 580675 | 3    | 193558 | F (3, 16) = 21.07 | P < 0.0001 |
| Groups Within Groups | 146990 | 16   | 9187   |                   |            |
| Total                | 727665 | 19   |        |                   |            |  
| BRP   | 3.85   |
|-------|--------|
| WRP   | 1.92   |
untitled h1
16.3.2 lb-100 tissue

| Sample Name   | Calculated Concentration   |          |         |
|---------------|----------------------------|----------|---------|
| LB-100 tissue | Day 1                      | Day 2    | Day 3   |
| H             | 3.05                       | 2.67     | 3.22    |
| G             | 9.25                       | 10.19    | 10.55   |
| F             | 28.17                      | 32.70    | 31.86   |
| E             | 101.13                     | 106.41   | 101.28  |
| D             | 292.02                     | 294.28   | 292.85  |
| C             | 996.24                     | 942.92   | 960.10  |
| B             | 2905.33                    | 2903.10  | 2879.97 |
| A             | 10135.85                   | 10350.06 | 9981.22 |
| LOQ           | 2.89                       | 3.21     | 2.66    |
| LQC           | 7.03                       | 8.17     | 7.00    |
| MQC           | 1871.82                    | 1876.91  | 1722.76 |
| HQC           | 7756.64                    | 7715.07  | 7816.03 |
| LOQ           | 2.98                       | 2.97     | 3.02    |
| LQC           | 6.92                       | 7.27     | 6.56    |
| MQC           | 1849.08                    | 1876.22  | 1816.34 |
| HQC           | 8213.18                    | 7792.95  | 7608.25 |
| LOQ           | 1.80                       | 3.57     | 2.64    |  
| LQC       | 6.40        | 7.88        | 6.91        |
|-----------|-------------|-------------|-------------|
| MQC       | 1906.27     | 1790.11     | 1838.19     |
| HQC       | 8234.50     | 8057.81     | 7662.84     |
| LOQ       | 1.04        | 2.66        | 3.63        |
| LQC       | 6.92        | 8.00        | 7.32        |
| MQC       | 1935.47     | 1846.60     | 1827.07     |
| HQC       | 8129.39     | 7774.61     | 7650.04     |
| LOQ       | 4.21        | 4.97        | 2.73        |
| LQC       | 6.84        | 7.45        | 7.61        |
| MQC       | 1967.56     | 1787.57     | 1882.56     |
| HQC       | 8266.66     | 7652.88     | 7927.77     |
| H         | 3.02        | 3.26        | 2.68        |
| G         | 1.50        | 9.96        | 10.27       |
| F         | 30.41       | 33.43       | 31.29       |
| E         | 112.10      | 97.67       | 100.82      |
| D         | 301.06      | 285.99      | 292.89      |
| C         | 1014.10     | 931.49      | 953.40      |
| B         | 1422.93     | 2804.38     | 2873.89     |
| A         | 4232.95     | 10256.63    | 10519.78    |
| 4/27/2016 | 5/2/2016    | 5/3/2016    |             |
| Linearity | AVG         | SD          |             |
| Day 1     | 0.997142045 | 0.996223902 | 0.001404329 |
| Day 2     | 0.99460729  |             |             |  
Day 3 0.996922372  
Day 1-1  
Day 1-2  
Day 2-1  
Day 2-2  
Day 3-1  
Day 32  
GM (ng/ mL)  
3 3.05 3.02 2.67 3.26 3.22 2.68 2.98 0.26 -  
0.56%  
8.59 %  
6  
| Nomina l  (pg/mg) 10000.0 0   |
|-------------------------------|  
10.00 9.25 10.1  
9  
9.96 10.5  
5  
10.27 10.04 0.49 0.44% 4.89  
%  
5  
30.00 28.1  
7  
30.4 1  
32.7 0  
33.4 3  
31.8 6  
31.29 31.31 1.87 4.37% 5.96  
%  
6  
100.00 101.  
13  
112. 10  
106. 41  
97.6 7  
101. 28  
100.82 103.2  
4  
5.17 3.24% 5.01  
%  
6  
| GM  (ng/ mL)   | SD     | DEV      | R.S.D   | n    |    |
|----------------|--------|----------|---------|------|----|
| (ng/mL)        | (%)    | (%) 8.59 | 6       |      |    |
| 0.56%          | %      |          |         |      |    |
| 10.27          | 10.04  | 0.49     | 0.44%   | 4.89 | 5  |
| %              |        |          |         |      |    |
| 31.29          | 31.31  | 1.87     | 4.37%   | 5.96 | 6  |
| %              |        |          |         |      |    |
| 5.17           | 3.24%  | 5.01     | 6       |      |    |
| 4              | %      |          |         |      |    |
| 4.83           | -      | 1.65     | 6       |      |    |
| 8              | 2.27%  | %        |         |      |    |
| 32.08          | -      | 3.32     | 6       |      |    |
| 8              | 3.36%  | %        |         |      |    |
| 2873.          | 40.95  | -        | 1.43    | 5    |    |
| 33             | 4.22%  | %        |         |      |    |
| 1024           | 205.00 | 2.49%    | 2.00    | 5    |    |
| 8.71           | %      |          |         |      |    |  
300.00 292.  
02  
301. 06  
294. 28  
285. 99  
292. 85  
292.89 293.1  
8  
4.83 -  
2.27%  
1.65 %  
6  
1000.00 996.  
24  
1014 .10  
942. 92  
931. 49  
960. 10  
953.40 966.3  
8  
32.08 -  
3.36%  
3.32 %  
6  
3000.00 2905  
.33  
2903 .10  
2804 .38  
287 9.97  
2873.8 9  
2873. 33  
40.95 -  
4.22%  
1.43 %  
5  
10000.0 0  
1013 5.85  
1035 0.06  
1025 6.63  
998 1.22  
10519. 78  
1024 8.71  
205.00 2.49% 2.00  
%  
5  
| LLOQ QC   | Day 1   | Day 2   | Day 3   | GM   | SD      | DEV    |
|-----------|---------|---------|---------|------|---------|--------|
| 3 pg/mg   | 2.89    | 3.21    | 2.66    | 3.00 | 0.91963 | -0.04% |
| 2.98      | 2.97    | 3.02    |         |      |         |        |
| 1.80      | 3.57    | 2.64    |         |      |         |        |
| 1.04      | 2.66    | 3.63    |         |      |         |        |
| 4.21      | 4.97    | 2.73    |         |      |         |        |  
| ANOVA Source of      | SS    | df    | MS     | F                 | P-value    |        |
|----------------------|-------|-------|--------|-------------------|------------|--------|
| Variation Between    | 2.019 | 2     | 1.009  | F (2, 12) = 1.233 | P = 0.3258 |        |
| Groups Within Groups | 9.821 | 12    | 0.8184 |                   |            |        |
| Total                | 11.84 | 14    |        |                   |            |        |
| BRP                  | 6.51  |       |        |                   |            |        |
| WRP                  | 30.17 |       |        |                   |            |        |
| Low QC               | Day 1 | Day 2 | Day 3  | GM                | SD         | DEV    |
| 8 pg/mg              | 7.03  | 8.17  | 7.00   | 7.22              | 0.51941    | -9.77% |
| 6.92                 | 7.27  | 6.56  |        |                   |            |        |
| 6.40                 | 7.88  | 6.91  |        |                   |            |        |
| 6.92                 | 8.00  | 7.32  |        |                   |            |        |
| 6.84                 | 7.45  | 7.61  |        |                   |            |        |  
| ANOVA Source of      | SS    | df   | MS     | F                 | P-value    |
|----------------------|-------|------|--------|-------------------|------------|
| Variation Between    | 2.316 | 2    | 1.158  | F (2, 12) = 9.509 | P = 0.0034 |
| Groups Within Groups | 1.461 | 12   | 0.1218 |                   |            |
| Total                | 3.777 | 14   |        |                   |            |
| BRP                  | 6.31  |      |        |                   |            |  
| WRP   | 4.83   |
|-------|--------|  
Middle QC Day 1 Day 2 Day 3 GM SD DEV 2000 pg/mg 1871.82 1876.91 1722.76 1852.97 61.2912 -7.35%  
1849.08 1876.22 1816.34 1906.27 1790.11 1838.19 1935.47 1846.60 1827.07 1967.56 1787.57 1882.56  
High QC Day 1 Day 2 Day 3 GM SD DEV 8000 pg/mg 7756.64 7715.07 7816.03 7883.91 234.934 -1.45%  
8213.18 7792.95 7608.25 8234.50 8057.81 7662.84 8129.39 7774.61 7650.04 8266.66 7652.88 7927.77  
| ANOVA Source of      | SS     | df   | MS     | F                 | P-value    |
|----------------------|--------|------|--------|-------------------|------------|
| Variation Between    | 429092 | 2    | 214546 | F (2, 12) = 7.492 | P = 0.0077 |
| Groups Within Groups | 343626 | 12   | 28636  |                   |            |
| Total                | 772718 | 14   |        |                   |            |
| BRP                  | 2.45   |      |        |                   |            |  
Version Date: *06/02/2022*  
| WRP   | 2.15   |
|-------|--------|