24 min
Issue 38 — Optimal Preclinical Formulation and Drug Product Manufacture Altasciences
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- Science
Explore the key considerations for successful formulation development and manufacture for safety assessment, and learn about the strategies Altasciences employs to support sponsors.
- 0:35 — Introduction
- 3:34 — Considerations for Preclinical Drug Formulation
- 7:36 — Preclinical Drug Product Manufacturing
- 9:46 — Steps in Preclinical Drug Product Manufacturing
- 13:49 — Quality Assurance and Control
- 14:33 — Regulatory Aspects
- 15:42 — Risk Management
- 17:17 — Case Study
- 21:27 — Conclusion
Formulating and manufacturing drugs for preclinical testing is an early, crucial step toward human trials. At the preclinical stage, the goal is to maximize exposure for safety testing, formulating to the limits of solubility and maximum volumes. To optimize the formulation for preclinical testing, one must consider the route of administration, selection of excipients, stability testing, plans and options for scale-up, and contingency plans.
Explore the key considerations for successful formulation development and manufacture for safety assessment, and learn about the strategies Altasciences employs to support sponsors.
- 0:35 — Introduction
- 3:34 — Considerations for Preclinical Drug Formulation
- 7:36 — Preclinical Drug Product Manufacturing
- 9:46 — Steps in Preclinical Drug Product Manufacturing
- 13:49 — Quality Assurance and Control
- 14:33 — Regulatory Aspects
- 15:42 — Risk Management
- 17:17 — Case Study
- 21:27 — Conclusion
Formulating and manufacturing drugs for preclinical testing is an early, crucial step toward human trials. At the preclinical stage, the goal is to maximize exposure for safety testing, formulating to the limits of solubility and maximum volumes. To optimize the formulation for preclinical testing, one must consider the route of administration, selection of excipients, stability testing, plans and options for scale-up, and contingency plans.
24 min