AADAP’s Research Focus and Areas of Expertise (updated 19 July 2011)...

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. Hypothesis formulation, experimental design and conduct, and statistical 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 written 14 FDA-accepted efficacy research protocols (click here to view efficacy protocols) and have conducted field efficacy studies with 11 drugs:

Drug	Use(s)	Product name(s)
Chloramine-T	External antibacterial	Halamid® AQUA, Actamide
Hydrogen peroxide	External antibacterial, fungicide, and parasiticide	35% PEROX-AID®
Lauryl methyl pyrifrin	External antibacterial and fungicide	AquaFrin®
Florfenicol	Systemic antibacterial	AQUAFLOR®
Oxytetracycline	Systemic antibacterial and skeletal (fluorescent) marking	TERRAMYCIN® 200 for Fish
Calcein	Skeletal (fluorescent) marking	SE-MARK®
Emamectin benzoate	Parasiticide	SLICE®
Eugenol	Sedative	AQUI-S® 20E and AQUI-S® E
Isoeugenol	Sedative	AQUI-S®
Benzocaine	Sedative	Benzoak®
17α-methyltestosterone	Sex-reversal of tilapia	none

To date, we have written seven FDA-accepted TAS research protocols (click here to view TAS protocols) and have conducted or coordinated TAS studies with five drugs:

Drug	Use(s)	Product name(s)
Chloramine-T	External antibacterial	Halamid® AQUA, Actamide
Florfenicol	Systemic antibacterial	AQUAFLOR®
Emamectin benzoatea	Parasiticide	SLICE®
Eugenol	Sedative	AQUI-S® 20E and AQUI-S® E
Isoeugenol	Sedative	AQUI-S®
17α-methyltestosterone	Sex-reversal of tilapia	none
a study is pending (Note: The pivotal TAS protocol for SLICE® has not yet been posted on the web.)

We note that expertise associated with the design and conduct of TAS studies includes the establishment and maintenance of a 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. AFS FCS Working Group on Aquaculture Drugs, Chemicals, and Biologics
2. Association of Fish and Wildlife Agencies Drug Approval Working Group (participants)
3. Therapeutic Drug Research special session annually at the Aquaculture America/World Aquaculture Society Meeting (Co-Moderators),
4. Aquatic Animal Drug Approval Workshop instructors/lecturers