Overview of Safety Pharmacology Studies

Protheragen provides a full suite of in vivo and in vitro safety pharmacology studies evaluating the potential effects of anti-obesity therapeutics on central nervous, respiratory, cardiovascular system, gastrointestinal motility, and renal function. Our team members have professional backgrounds in pharmacology, Toxicology, and veterinary medicine and are skilled in the core combination of safety pharmacology tests to evaluate the effects of subjects on central nervous, cardiovascular, and respiratory functions in a variety of species, including non-human primates, canines, minipigs, rats and mouse.

Safety pharmacology evaluates the potential adverse effects of drugs at therapeutic or higher doses, particularly on the central nervous, cardiovascular, and respiratory systems, with possible extension to other organs such as the urinary, autonomic nervous system, and digestive system. This study aims to identify potential pharmacological effects relevant to clinical safety, to evaluate adverse effects, and to investigate their mechanisms of action.

Safe Pharmacology - Ensuring Safety Every Step of the Way

The core purpose of safety pharmacology studies is to identify possible adverse effects of anti-obesity therapeutics, to assess and minimize the associated risks, and to predict the safe range of use of anti-obesity therapeutics. Our company is committed to providing comprehensive in vitro and in vivo safety pharmacology research services. Regardless of the study methodology, molecule type, or therapeutic indication chosen by the client, we provide comprehensive safety pharmacology study support.

• Effects on the Central Nervous System (CNS)

  To comprehensively assess the effects of anti-obesity therapeutics on CNS, a variety of behavioral and physiological testing methods were employed. These tests include:

  • Handgrip test
  • Irwin test: Mouse, rat
  • Rotarod test

  • Functional observation bundle test (FOB): Monkey, dog, rat
  • Electroencephalogram (EEG) test
  • Spontaneous neural activity

• Effects on Gastrointestinal Tract

  Our company performs improved more extensive gastrointestinal screening of anti-obesity therapeutics in preclinical development, which helps to better predict clinical outcomes. We primarily assess gastrointestinal dynamics, nausea and vomiting, secretory function (primarily gastric juice secretion), and absorption aspects. For example, we offer high-quality mouse and rat gastrointestinal motility tests.

• Effects on Cardiovascular System

  At Protheragen, We provide in vitro and in vivo cardiovascular safety assessment services.

  

• Effects on Metabolic and Endocrine Systems

  Our company has a strong focus on the impact of anti-obesity therapeutics on the metabolic and endocrine systems. We offer a range of evaluation services including, but not limited to, testing of urine volume, specific gravity, osmolality, pH, electrolyte balance, proteins, and cellular and blood biochemistry (e.g., urea, creatinine, proteins).

• Impact on Nutrient Absorption

  Importantly, we offer anti-obesity therapeutics to assess nutrient absorption in living organisms. We provide clients with comprehensive safe pharmacology studies through the digestion and absorption of nutrients such as sugars, fats, and proteins in the gut.

Workflow

We have professional safety pharmacology research experts to plan your anti-obesity therapy safety assessment program. Through detailed communication, our researchers determine the usage and testing indexes and customize a personalized service plan for clients. Relying on state-of-the-art evaluation services and superior technology, our skilled staff provides you with a full range of safety pharmacology studies. All data reports are delivered to your mailbox as soon as possible.

Applications

• Safety pharmacology studies can be used to identify undesired pharmacological effects of anti-obesity therapies that may be relevant to human safety.
• Safety pharmacology studies are a key step in the design and optimization of anti-obesity therapeutics.
• Safety pharmacology studies provide important data for the development of novel anti-obesity drugs.

Advantages of Us

• We have a team of safety pharmacologists with extensive expertise and practical experience to provide professional, in-depth, and accurate safety assessment solutions for anti-obesity therapeutics to our clients.
• Our researchers are highly experienced in the industry. From needs analysis to program implementation, we ensure that our services are precisely aligned with clients' needs.
• Through strict internal management and quality control processes, we ensure that every aspect of safety pharmacology research meets high standards and requirements.

Your Most Reliable Partner

Our team brings together top experts and technicians in the field of obesity research, specializing in the precise labeling and analysis of adipocytes, metabolism-related proteins, hormones, and signaling molecules. The obesity research services provided by our company focus on an in-depth exploration of the causes, developmental mechanisms, predictions, and biomarkers of obesity through scientific means. Given the critical role of animal models in the development of obesity therapies, we offer specialized customized services to establish animal models that are highly consistent with the pathophysiological characteristics of obesity. These models are an indispensable and valuable resource for evaluating the efficacy and safety of drug candidates and for conducting pharmacokinetic studies.

Learn More about Obesity Services

Publication Data

Frequently Asked Questions

What is the purpose of a security assessment?

Safety pharmacology aims to identify unintended pharmacological effects that a drug may have on human safety, to assess the adverse reactions and pathophysiological effects of a drug observed in toxicological or clinical studies, and to investigate the underlying mechanisms of these adverse reactions.

What types of routes of administration does our company offer?

We primarily offer these routes of administration. Oral routes include gavage and capsule forms. Non-intestinal routes cover intraperitoneal, intravenous, intramuscular, intradermal, subcutaneous, continuous infusion, and intravitreal injections. The other modes of administration include nasal, intranasal, ophthalmic, rectal, vaginal, implantation, and inhalation.

Protheragen is committed to being your most trusted partner in safety pharmacology research. Relying on comprehensive obesity models and advanced biotechnologies, we provide our clients with safe pharmacology research solutions. Feel free to contact us.

All of our services and products are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.

• Toxicology Studies