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Consistency Evaluation of Veterinary Generic Drugs

CD Formulation is a leading provider of preclinical and clinical testing services for generic veterinary drugs. Through our integrated capabilities in pharmacokinetics, formulation development and bioanalytical sciences, we conduct comprehensive bioequivalence studies across relevant species. In addition to standalone bioequivalence trials, we offer full generic drug development programs including manufacturing process validation and stability testing.

What is Generic Drug Consistency Evaluation?

Consistency evaluation, also known as bioequivalence testing, establishes that a generic veterinary drug is interchangeable with the branded reference product. It demonstrates that the generic has consistent quality, safety and efficacy. Studies involve administering the generic and reference to animals and comparing their pharmacokinetic profiles. Parameters like maximum concentration, time to peak and overall exposure are measured to ensure they are within acceptable equivalence ranges.

What Can We Do for Veterinary Generic Drug Development?

Consistency Evaluation of Quality

We develop in vitro dissolution test methods to ensure the consistent release of active ingredients from generic drug formulations.
Our team validates bioanalytical methods to accurately quantify drugs and metabolites in various matrices, ensuring reliable analytical measurements.
We provide formulation design and production scale-up support to achieve consistent quality and performance in generic tablets and capsules.
Stability testing under ICH conditions is conducted to assess the long-term stability of generic drug formulations, ensuring their quality over time.
We offer expert consulting on global approval requirements, regulatory pathways, and strategies for gaining market access to veterinary generic drugs.

Consistency Evaluation of Efficacy

In vivo pharmacokinetic studies are conducted on various animal species to assess the absorption, distribution, metabolism, and elimination characteristics of generic drugs.
Randomized, blinded, cross-over clinical trials are designed and executed to compare the pharmacokinetic profiles and bioavailability of generic drugs and their reference products in animals.
Pharmacokinetic data modeling and statistical equivalence analysis are performed to determine the bioequivalence of generic drugs, establishing their comparability to reference products in terms of systemic exposure and therapeutic effect.

Our Focus Areas for Veterinary Generic Drug Research

Development of Veterinary Antibiotics and Antimicrobials

We conduct research on generic formulations of antibiotics and antimicrobials used in veterinary medicine, aiming to enhance their efficacy, safety, and compliance. This includes optimization of drug delivery systems, dosage forms, and combination therapies to combat bacterial infections in animals.

Development of Veterinary Anti-inflammatory Drugs

Our research focuses on developing generic versions of anti-inflammatory drugs for veterinary use, including nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids. We aim to improve their bioavailability, duration of action, and minimize potential side effects.

Development of Veterinary Parasiticides

We investigate and optimize generic formulations of parasiticides, such as anthelmintics and ectoparasiticides, used to treat and prevent infestations in animals. Our research emphasizes improving drug delivery systems, efficacy against various parasites, and minimizing resistance development.

Development of Veterinary Cardiac Drugs

Our research explores generic alternatives to cardiac medications used in veterinary practice, including drugs for heart failure, arrhythmias, and hypertension. The focus is on developing formulations with improved bioavailability, controlled release, and enhanced patient compliance.

Why Choose Our Veterinary Generic Drug Consistency Evaluation Services?

Our services encompass comprehensive analysis of critical parameters, including drug content, impurities, dissolution rate, particle size, and physical properties.
We conduct pharmacokinetic studies, which involve evaluating the absorption, distribution, metabolism, and elimination of veterinary generic drugs in animal subjects.
We are equipped with various types of chromatography/spectrometers, atomic absorption analyzers, dissolution apparatus, and formulation/coating equipment to ensure project completion and efficient time.
Our experienced team can provide support with formulation optimization and clinical BE risk reduction.

CD Formulation has extensive experience conducting in vitro dissolution testing, bioanalytical method development and validation, formulation design, and in vivo bioequivalence studies. If you are looking to assess the consistency of your veterinary generic drugs, please feel free to contact us!

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