Veterinary Drugs

The objective of the present study was to develop a tablet formulation of embelin employing the wet granulation and direct compression techniques.

Drugs have been compounded for veterinary practice for many years because it has been necessary in the course of routine practice. However, regulations and compliance policy guidelines (CPGs) should be recognized. A new CPG issued in July 2003 listed the current Food and Drug Administration (FDA) limitations on compounding for veterinary medicine. To summarize the guideline: drugs must not be compounded from bulk substances, and the compounding must not constitute manufacture of a new animal drug. Drug compounding on a case-by-case basis is allowed under the CPG. However, veterinarians and pharmacists must be aware of potential incompatibilities and practices that may interfere with the drug’s stability, purity, and/or potency.

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It is our pleasure to present the second theme issue of the AAPS Journal (formerly AAPS PharmSci) pertaining to veterinary pharmacology. Recognizing that our human health counterparts rarely have the opportunity to examine the activities affecting veterinary medicine, these theme issues represent an effort to enhance interdisciplinary communication.

Since publishing the first AAPS PharmSci veterinary theme issue in 2002, the Food and Drug Administration Center for Veterinary Medicine (CVM) has enjoyed numerous accomplishments. Between the year 2002 and July 2005, CVM published 43 guidance documents (Table 1). Sixteen of these guidance documents were written in collaboration with the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), a trilateral (EAU-Japan-USA) program aimed at harmonizing technical requirements for veterinary product registration.1

Pharmacokinetic (PK)/pharmacodynamic (PD) modeling is a scientific tool to help developers select a rational dosage regimen for confirmatory clinical testing. This article describes some of the limitations associated with traditional dose-titration designs (parallel and crossover designs) for determining an appropriate dosage regimen. It also explains how a PK/PD model integrates the PK model (describing the relationship between dose, systemic drug concentrations, and time) with the PD model (describing the relationship between systemic drug concentration and the effect vs time profile) and a statistical model (particularly, the intra- and interindividual variability of PK and/or PD origin). Of equal importance is the utility of these models for promoting rational drug selection on the basis of effectiveness and selectivity. PK/PD modeling can be executed using various approaches, such as direct versus indirect response models and parametric versus nonparametric models.

Increasing resistance to antimicrobial agents is of growing concern to public health officials worldwide. The concern includes infections acquired in hospitals, community infections acquired in outpatient care settings, and resistant foodborne disease associated with drug use in food-producing animals. In the United States, a significant source of antimicrobial-resistant foodborne infections in humans is the acquisition of resistant bacteria originating from animals. The US Food and Drug Administration’s (FDA’s) goal in resolving the public health impact arising from the use of antimicrobial drugs in food-producing animals is to ensure that significant human antimicrobial therapies are not compromised or lost while providing for the safe use of antimicrobials in food animals. The FDA’s approach to the problem is multipronged and innovative.

Fundamental aspects of electrolyte chemistry were used to design an appropriate dissolution medium with the capacity to maintain sink conditions throughout the test. Dissolution of various bolus dosage forms was studied using USP Apparatus II at various stirring speeds. Complete dissolution of each drug in the designed medium was achieved, and there is evidence that such a dissolution test could be discriminating. This review details the development of potentially discriminating in vitro dissolution tests for veterinary boluses using USP Apparatus II and examines the potential role of such testing during product quality assessments, in the evaluation of postapproval manufacturing changes and for the establishment of the generic equivalence of veterinary products.

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Residues are composed of the parent drug and metabolites, and therefore interspecies comparisons must involve a consideration of comparative xenobiotic metabolism. The focus of this article will be the residue studies that are required to establish human food safety, and the interspecies pharmacokinetic differences and similarities that impact drug residues in animal- derived foods. To illustrate the factors that can complicate and assist these comparisons, 2 drugs will be examined in detail: ivermectin and fenbendazole. In addition, the activities of 2 US programs, the Food Animal Residue Avoidance Databank (FARAD) and the NRSP-7 (National Research Support Project Number 7) Minor Use Animal Drug Program will be presented, along with strategies that may be employed in the study of species differences.