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Overview of drug product development
1Pharmaceutics Scios, Sunnyvale, California, USA.
Current Protocols in Pharmacology
|October 1, 2011
Summary
Drug product development, or formulation chemistry, creates drug formulations for safety testing and market supply. This process covers dosage forms, toxicology formulation, and manufacturing development.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery
- Formulation Chemistry
Background:
- Drug product development is crucial for advancing pharmaceuticals from concept to market.
- Formulation chemistry ensures drug efficacy and safety through precise development processes.
Purpose of the Study:
- To provide a comprehensive overview of the drug product development process.
- To detail key stages including formulation for toxicology and clinical studies, and commercial manufacturing.
Main Methods:
- Describing the overall drug product development lifecycle.
- Highlighting considerations for various dosage forms and delivery routes.
- Outlining ingredient selection and manufacturing process development strategies.
Main Results:
- The development process encompasses diverse dosage forms for multiple delivery routes.
- Toxicology formulation development requires specific considerations for safety assessment.
- Manufacturing process development ensures scalability and reproducibility.
Conclusions:
- Successful drug product development integrates formulation, toxicology, and manufacturing expertise.
- Optimized formulation and manufacturing are essential for successful clinical trials and commercialization.
- This overview serves as a foundational guide for drug product development professionals.
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