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q1-microbio.pptx
protocol-v3.docx
cohort-2034.xlsx
tox-rat.pdf
batch-release.eml
Smart Parsing
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01
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scan_0412.pdf
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data-sharing-agreement.pdf
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task-protocol-v4.pdf
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data_export.xlsx
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letters-2023.pdf
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analysis-plan.docx
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13miller-2023-preprint-v2.pdf
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session-counts-cohort-b.xlsx
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ICH_E11A_paediatric_extra.pdf
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old-letter-1998.pdf
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summary.xlsx
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adolescent-cohort-report.pdf
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Inbox 23
Library 35
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7scan_0412.pdf
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data-sharing-agreement.pdf
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task-protocol-v4.pdf
New version of a source?
data_export.xlsx
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letters-2023.pdf
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- W
analysis-plan.docx
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To review
13miller-2023-preprint-v2.pdf
Article · → Literature
session-counts-cohort-b.xlsx
Dataset · → Study data
ICH_E11A_paediatric_extra.pdf
Added by the agent
old-letter-1998.pdf
Scanned, OCR needed
summary.xlsx
Dataset · → Study data
adolescent-cohort-report.pdf
Study report · → Study data
02
Draft with AI
Purpose-built AI drafts from the parsed data, following guidelines (e.g. ICH M4 CTD) and your templates.
4.3 Dose proportionality
Table 3. Dose proportionality of VLM-101 exposure
Session
Let’s draft Table 3: dose proportionality
Checking 32 sources & drafting the table
Ask about this selection...
4.3 Dose proportionality
Table 3. Dose proportionality of VLM-101 exposure
Session
Let’s draft Table 3: dose proportionality
Checking 32 sources & drafting the table
Ask about this selection...
03
Review and refine
Review, edit and query the draft with AI, then expert validation and QC.
Table 2. Mean plasma pharmacokinetic parameters of VLM-101 after a single oral dose
Study ID Species Cmax (ng/mL) Sex Dose (mg/kg) n Tmax (h) AUC0–24 (ng·h/mL) t½ (h) F (%) PK-001 Mouse 412 ± 58 M/F 3 6 0.50 2,140 ± 310 6.1 ± 0.6 64 PK-001 Mouse 1,380 ± 190 M/F 10 6 0.50 7,050 ± 880 6.4 ± 0.5 66 PK-001 Mouse 4,020 ± 520 M/F 30 5ᵃ 1.00 21,600 ± 2,400 6.3 ± 0.7 63 PK-002 Rat 960 ± 140 M 10 3 1.00 8,820 ± 1,050 8.2 ± 0.9 71 PK-002 Rat 2,870 ± 330 M 30 3 1.00 26,900 ± 3,100 8.5 ± 1.1 69 PK-003 Dog 520 ± 90 M 3 2 2.00 6,410 ± 950 11.8 78 PK-003 Dog 1,690 ± 260 M 10 2 2.00 20,300 ± 2,800 11.2 76 PK-004 Minipig 610 ± 95 M 3 3 1.50 5,890 ± 720 9.4 ± 1.2 58 PK-004 Minipig 1,950 ± 280 M 10 3 1.50 19,400 ± 2,300 9.8 ± 1.0 60 PK-005 Monkey 185 ± 32 M/F 1 4 2.00 1,720 ± 260 10.6 ± 1.4 52 PK-005 Monkey 540 ± 88 M/F 3 4 2.00 5,260 ± 690 10.9 ± 1.3 54 PK-005 Monkey 1,790 ± 240 M/F 10 4 2.50 18,100 ± 2,500 11.3 ± 1.6 55 PK-006 Rabbit 1,120 ± 170 F 10 3 0.75 6,940 ± 910 5.2 ± 0.6 47 Comment
Table 2. Mean plasma pharmacokinetic para...
4,020 ± 520
Natalia Azerg10 Sept
@Guillaume, this data got updated last week, just sent you the new report
Guillaume Marq10 Sept
Perfect!
Reply
Table 2. Mean plasma pharmacokinetic parameters of VLM-101 after a single oral dose
Study ID Species Cmax (ng/mL) Sex Dose (mg/kg) n Tmax (h) AUC0–24 (ng·h/mL) t½ (h) F (%) PK-001 Mouse 412 ± 58 M/F 3 6 0.50 2,140 ± 310 6.1 ± 0.6 64 PK-001 Mouse 1,380 ± 190 M/F 10 6 0.50 7,050 ± 880 6.4 ± 0.5 66 PK-001 Mouse 4,020 ± 520 M/F 30 5ᵃ 1.00 21,600 ± 2,400 6.3 ± 0.7 63 PK-002 Rat 960 ± 140 M 10 3 1.00 8,820 ± 1,050 8.2 ± 0.9 71 PK-002 Rat 2,870 ± 330 M 30 3 1.00 26,900 ± 3,100 8.5 ± 1.1 69 PK-003 Dog 520 ± 90 M 3 2 2.00 6,410 ± 950 11.8 78 PK-003 Dog 1,690 ± 260 M 10 2 2.00 20,300 ± 2,800 11.2 76 PK-004 Minipig 610 ± 95 M 3 3 1.50 5,890 ± 720 9.4 ± 1.2 58 PK-004 Minipig 1,950 ± 280 M 10 3 1.50 19,400 ± 2,300 9.8 ± 1.0 60 PK-005 Monkey 185 ± 32 M/F 1 4 2.00 1,720 ± 260 10.6 ± 1.4 52 PK-005 Monkey 540 ± 88 M/F 3 4 2.00 5,260 ± 690 10.9 ± 1.3 54 PK-005 Monkey 1,790 ± 240 M/F 10 4 2.50 18,100 ± 2,500 11.3 ± 1.6 55 PK-006 Rabbit 1,120 ± 170 F 10 3 0.75 6,940 ± 910 5.2 ± 0.6 47 Comment
Table 2. Mean plasma pharmacokinetic para...
4,020 ± 520
Natalia Azerg10 Sept
@Guillaume, this data got updated last week, just sent you the new report
Guillaume Marq10 Sept
Perfect!
Reply
04
Export to Word
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Export to WordPharmacokinetics and Exposure of VLM-101 in Rodent and Non-Rodent Species
Study Report VLM-101-PK-003 · Section 4.2 · Draft v0.6
Plasma exposure to VLM-101 was assessed after single oral administration in mice, rats and dogs. Mean parameters are summarised in Table 2; individual animal values are listed in Appendix 3.
Table 2. Mean plasma pharmacokinetic parameters of VLM-101 after a single oral dose
Study ID Species Cmax (ng/mL) Sex Dose (mg/kg) n Tmax (h) AUC0–24 (ng·h/mL) t½ (h) F (%) PK-001 Mouse 412 ± 58 M/F 3 6 0.50 2,140 ± 310 6.1 ± 0.6 64 PK-001 Mouse 1,380 ± 190 M/F 10 6 0.50 7,050 ± 880 6.4 ± 0.5 66 PK-001 Mouse 4,020 ± 520 M/F 30 5ᵃ 1.00 21,600 ± 2,400 6.3 ± 0.7 63 PK-002 Rat 960 ± 140 M 10 3 1.00 8,820 ± 1,050 8.2 ± 0.9 71 PK-002 Rat 2,870 ± 330 M 30 3 1.00 26,900 ± 3,100 8.5 ± 1.1 69 PK-003 Dog 520 ± 90 M 3 2 2.00 6,410 ± 950 11.8 78 PK-003 Dog 1,690 ± 260 M 10 2 2.00 20,300 ± 2,800 11.2 76 Values are mean ± SD. ᵃ One animal excluded (regurgitation post-dose, DEV-0117). F, oral bioavailability relative to a 1 mg/kg IV dose.
4.3 Dose proportionality
Cmax and AUC0–24 increased approximately in proportion to dose between 3 and 30 mg/kg in mice (power-model slope 0.98 and 1.01, respectively). In rats, exposure at 30 mg/kg was 3.0-fold that at 10 mg/kg. No sex differences were observed in mice. The terminal half-life was independent of dose in all species, supporting once-daily administration in the first-in-human study.
Export to WordPharmacokinetics and Exposure of VLM-101 in Rodent and Non-Rodent Species
Study Report VLM-101-PK-003 · Section 4.2 · Draft v0.6
Plasma exposure to VLM-101 was assessed after single oral administration in mice, rats and dogs. Mean parameters are summarised in Table 2; individual animal values are listed in Appendix 3.
Table 2. Mean plasma pharmacokinetic parameters of VLM-101 after a single oral dose
Study ID Species Cmax (ng/mL) Sex Dose (mg/kg) n Tmax (h) AUC0–24 (ng·h/mL) t½ (h) F (%) PK-001 Mouse 412 ± 58 M/F 3 6 0.50 2,140 ± 310 6.1 ± 0.6 64 PK-001 Mouse 1,380 ± 190 M/F 10 6 0.50 7,050 ± 880 6.4 ± 0.5 66 PK-001 Mouse 4,020 ± 520 M/F 30 5ᵃ 1.00 21,600 ± 2,400 6.3 ± 0.7 63 PK-002 Rat 960 ± 140 M 10 3 1.00 8,820 ± 1,050 8.2 ± 0.9 71 PK-002 Rat 2,870 ± 330 M 30 3 1.00 26,900 ± 3,100 8.5 ± 1.1 69 PK-003 Dog 520 ± 90 M 3 2 2.00 6,410 ± 950 11.8 78 PK-003 Dog 1,690 ± 260 M 10 2 2.00 20,300 ± 2,800 11.2 76 Values are mean ± SD. ᵃ One animal excluded (regurgitation post-dose, DEV-0117). F, oral bioavailability relative to a 1 mg/kg IV dose.
4.3 Dose proportionality
Cmax and AUC0–24 increased approximately in proportion to dose between 3 and 30 mg/kg in mice (power-model slope 0.98 and 1.01, respectively). In rats, exposure at 30 mg/kg was 3.0-fold that at 10 mg/kg. No sex differences were observed in mice. The terminal half-life was independent of dose in all species, supporting once-daily administration in the first-in-human study.
Led MAA and NDA submissions to approval
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