5. Link to Search Form links

Click on ‘Advanced Search’ to use proximity searching, combine words and add appropriate logic operators (and/or/not). Choose sources to search, including individual FDA Approval Package documents.

Use Chemistry Search to search by chemical structure, find exact, substructure and similar structures. NOTE: MDL® Draw must be installed to use this search.

The Extracted Data Search finds Adverse Effects and safety observations extracted from all FDA Approval documents, EMA EPARs and other trusted sources.

5.1. Browsing Data: Advance Search

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5.1.1. Search Example - Regulatory Affairs

Regulatory affairs is trying to find all committee comments and requests on previous AntiParkinson’s agents. This is to ensure they do not repeat costly mistakes made by others in submission and therefore delay the drug candidate's time to market.

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Filter the search using Antiparkinson agents (from Drugs and Drug Classes) and FDA Approval Packages (from Sources).

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Review the list of committee comments and requests retrieved. The second Apomorphine hit, discusses a problem with cardio submission data for example.

5.2 Extracted Data Search

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5.2.1. Search Example - Preclinical Safety/Toxicology

 Look for all rate and rhythm disorders associated with Monoclonal Antibodies.

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Add Adverse Effects/Toxicities by clicking on 'add', when located on the left. This form finds information in a similar way to how the browse features were used earlier in the guide.

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