8. Weight of Evidence vs Carcinogenicity Testing Part 1, with Bruce Pearce

Update: 2023-04-18

Description

The ICH has released a guidance which may allow you to forego animal carcinogenicity testing in favor of a weight of the evidence argument. We begin our two-part discussion of why to do that and how to do that with Bruce Pearce.

Comments

In Channel

15 Navigating CMC and Nonclinical Challenges with Novel Cell and Gene Therapy Products

2025-05-0624:56

14. When to take an early FDA meeting, with Aleese Hopkins and Samira Shirwa

2024-05-2116:07

13. Getting Out of Trouble, with Chris Vessely

2024-04-1618:10

12. Cybersecurity for Medical Devices, With Becky Ditty and DonnaBea Tillman

2023-11-1427:28

11. eCTD 4.0 and standardized data, with Ben Wimmer

2023-07-1818:55

10. Commercial Readiness, with Vince Narbut

2023-06-2015:35

9. Weight of Evidence vs Carcinogenicity Testing Part 2, with Bruce Pearce

2023-05-1627:36

8. Weight of Evidence vs Carcinogenicity Testing Part 1, with Bruce Pearce

2023-04-1818:14

7. Institutional Memory, with Kerin Ablashi

2023-03-2118:12

6. Potency Assays, with Diana Colleluori

2023-02-2124:07

5. When you should hire a consultant, with HeeSun Smaldore

2023-01-3115:53

4. Assembling Your Non-Clinical IND, with Emily Noonan Place

2023-01-1015:22

3. Gap analysis, with David Pepperl

2022-12-1321:19

2. In vivo cell therapy, with Robert Kutner

2022-11-2220:44

1. What a consultant can do for you, with Debra Barngrover

2022-11-0113:20

Insight at Biologics - Trailer

2022-10-2400:15

00:00

8. Weight of Evidence vs Carcinogenicity Testing Part 1, with Bruce Pearce

#box-pro-ellipsis-17656803131259{-webkit-line-clamp:2;}8. Weight of Evidence vs Carcinogenicity Testing Part 1, with Bruce Pearce

8. Weight of Evidence vs Carcinogenicity Testing Part 1, with Bruce Pearce

biologicsconsulting

8. Weight of Evidence vs Carcinogenicity Testing Part 1, with Bruce Pearce