AADAP’s Research Focus and Areas of Expertise...

The primary focus of our research program is demonstrating effectiveness and target animal safety (TAS) of aquaculture drugs through controlled field and laboratory studies. Integral to such studies are the following activities and associated areas of expertise:

1. Research protocol development
   
   
2. Experimental design and data analysis
   
   
3. Conducting studies in accordance with Good Clinical Practices (GCP) or Good Laboratory Practices (GLP)
   
   
4. Development of final products such as:
   
   
   • Final Study Reports
     
     
   • Freedom of Information Summaries
     
     
   • Technical section completions
     
     
5. Interacting with CVM’s Aquaculture Team in a manner to expeditiously obtain product concurrence

To date, we have developed seven effectiveness research protocols and conducted field effectiveness studies on eight aquaculture drugs:

1. Chloramine-T (Halamid^®)
   
   
2. Hydrogen peroxide (35% PEROX AID^®)
   
   
3. Oxytetracycline medicated feed (Terramycin 200 for Fish^®)
   
   
4. Florfenicol medicated feed (Aquaflor^®)
   
   
5. Oxytetracycline for marking fish skeletal tissue,
   
   
6. Calcein for marking fish skeletal tissue (SE-MARK^®),
   
   
7. Isoeugenol as a fish sedative (AQUI-S^®)
   
   
8. 17-α Methyltestosterone for producing male populations of fish.

We have also developed three TAS research protocols and conducted 12 TAS studies on two aquaculture drugs.  Expertise associated with the conduct of TAS studies includes the operation of a fully functional GLP-compliant histology lab.

In addition to our expertise in efficacy and TAS, we are involved in:

1. Addressing antimicrobial resistance issues outlined in Guidance Documents #152 and #159,
   
   
2. Drafting product label claims,
   
   
3. Drafting product labeling, and
   
   
4. Compiling information to complete All Other Information technical sections relative to effectiveness and safety.

Finally, we are active members/participants in the following groups and organizations:

1. Joint Subcommittee on Aquaculture’s (JSA) Working Group on Drugs, Biologics, and Pesticides
   
   
2. JSA’s National Aquaculture Drug Research Forum (Co-Chair)
   
   
3. NADRF Efficacy and TAS Technical Project Team (participants)
   
   
4. Association of Fish and Wildlife Agencies Drug Approval Working Group (participants)
   
   
5. Therapeutic Drug Research special session annually at the Aquaculture America/World Aquaculture Society Meeting (Co-Moderators),
   
   
6. Aquatic Animal Drug Approval Workshop instructors/lecturers