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32676 Conferences

Designing appropriate product specifications for lyophilized parenteral products

Added by Referral on 2011-03-03

Conference Dates:

Start Date Start Date: 2011-10-20
Last Date Last Day: 2011-10-20

Conference Contact Info:

Contact Person Contact Person: Referral
Email Email: referral@complianceonline.com
Address Address: 2600 E. Bayshore Road, Online Event,Palo Alto, CA, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

Why Should You Attend:

During the early phases of drug and formulation development, discovery regarding the quality attributes of a new drug substance or a new drug product emerge. Setting specifications is a critical part of the development, as this ultimately defines how a drug product can be considered, safe, effective and of an appropriate quality.

Lyophilized products to be used for injection have some typical requirements for appropriate testing. The appropriate tests are based upon determining the quality and efficacy of the drug, which is impacted not only by the manufacturing process but also by the physical changes which take place via lyophilization.

There are some tests which are commonly used to measure the quality and efficacy of the drug product, and these will be discussed. The discussion will focus on defining the appropriate procedures and establishing appropriate specification limits. The manufacture of sterile parenteral products includes the requirement of maintaining a higher requirement of safety for drug injection. There are some key factors involved in the testing for safety and how specifications will be determined.


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