In this issue, discover how to plan your preclinical assessment for a successful regulatory submission, including:

• An IND checklist

• Preclinical program considerations

• Estimating timelines

Click here to download a PDF, readable version of Issue 11: https://www.altasciences.com/sites/default/files/2019-11/The%20Altascientist_issue11_0.pdf

CHAPTERS:

- 0:23 — Section 1: Introduction

- 1:28 — Section 2: Prepare a Checklist

- 3:38 — Section 3: Plan Your Pivotal Toxicology Studies

- 5:05 — Section 4: Frequently Asked Questions in Preparing Your Preclinical Studies

- 6:50 — Section 5: Small Molecules vs. Biologics

- 7:58 — Section 6: Species Selection

- 8:48 — Section 7: Formulation, the Test Article, and Bioanalysis

- 11:36 — Section 8: Pivotal Toxicology Studies

- 12:52 — Section 9: Safety Pharmacology

- 14:06 — Section 10: Genetic Toxicology

- 15:54 — Section 11: SEND Data

- 16:39 — Section 12: Selecting the Right CRO for You

Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.