Get the free Parenteral Formulation Development and Drug Delivery - APV Mainz

Parenteral Formulation Development and Drug Delivery26 27 February 2019 Berlin, Germany Course no. 6763Hot Topics Target group Formulation scientists, line and project managers, research and development

How to fill out parenteral formulation development and

How to fill out parenteral formulation development and

1. Step 1: Gather all necessary information about the drug substance and its characteristics.
2. Step 2: Determine the desired delivery route for the parenteral formulation.
3. Step 3: Choose suitable excipients and additives based on the drug substance and route of administration.
4. Step 4: Conduct compatibility studies to ensure the compatibility of the drug substance with selected excipients.
5. Step 5: Develop a prototype formulation and evaluate its physicochemical properties.
6. Step 6: Perform stability studies to assess the long-term stability of the formulation.
7. Step 7: Optimize the formulation based on the results of stability and other performance tests.
8. Step 8: Prepare necessary documentation, including manufacturing instructions and quality control specifications.
9. Step 9: Validate the manufacturing process and perform in-process controls.
10. Step 10: Scale-up the manufacturing process and perform batch production.
11. Step 11: Conduct bioequivalence or bioavailability studies, if required.
12. Step 12: Monitor and evaluate the post-marketing performance of the parenteral formulation.

Who needs parenteral formulation development and?

1. Pharmaceutical companies developing injectable drugs.
2. Research institutions working on novel drug delivery systems.
3. Hospitals and clinics administering parenteral medications.
4. Regulatory authorities overseeing the approval and regulation of injectable formulations.
5. Healthcare professionals involved in drug development and patient care.

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What is parenteral formulation development and?

Parenteral formulation development is the process of developing formulations that can be administered through injection or infusion, bypassing the digestive system.

Who is required to file parenteral formulation development and?

Pharmaceutical companies and research institutions are required to file parenteral formulation development.

How to fill out parenteral formulation development and?

Parenteral formulation development can be filled out by submitting the necessary documentation and data to regulatory authorities.

What is the purpose of parenteral formulation development and?

The purpose of parenteral formulation development is to create safe and effective formulations for injection or infusion.

What information must be reported on parenteral formulation development and?

Information on the formulation composition, stability, manufacturing process, and preclinical/clinical data must be reported on parenteral formulation development.