Hybrid medicines are drugs based on a generic molecule and have a different route of administration, format, strength, or indication from the original reference product. They require re-approval for market authorization, partly based on data from the original reference medicine, and partly on data from new clinical trials on the modified version.

Click here to download a PDF, readable version of Issue 6: https://www.altasciences.com/sites/default/files/2022-04/The-Altascientist_issue6_505B2_2022.pdf

CHAPTERS:

- 0:08 — Section 1: An Introduction to Hybrid Medicines

- 1:41 — Section 2: Some Applicable Categories of Drugs for Hybrid or 505(b)(2) Pathways

- 5:06 — Section 3: Hybrid or 505(b)(2) vs. Generics

- 6:21 — Section 4: Choosing a Drug Candidate

- 9:30 — Section 5: Case Study — Achieving a 505(b)(2) Regulatory Approval

- 10:40 — Section 6: Case Study Continued — Study Methods

- 14:40 — Section 7: Case Study Continued — The Results

- 16:22 — Section 8: What Sets Altasciences Apart

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.