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

 

 

 

 
 
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Disclaimer: Product and company names mentioned in this website, or mentioned in materials accessed via this website, are for informational purposes only. The mention of such does not imply endorsement by the Aquatic Animal Drug Approval Partnership, the U.S. Fish & Wildlife Service or any other organization of the U.S. Government.

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LAST UPDATED: 16-Jan-2013