Safety Pharmacology

Safety Pharmacology, a branch of pharmacology, is specializing in the detection and study of potential undesirable pharmacodynamic effects of potential drugs on physiological functions associated with exposure in the therapeutic range and above. It is an essential step in assessing any potential adverse effects and potential life-threatening risks that drug candidates may bring to the main physiological system of the human body. Safety pharmacology aims to protect patients from adverse effects and minimize the risk of drug development failure due to undesirable pharmacodynamic effects.

Safety pharmacology, including core battery studies, follow-up studies and supplementary studies, can satisfy the key requirement in the drug discovery and development process, thus are required before first-in-human drug testing. Creative Biolabs is a pharmaceutical expertise who offers global clients with preclinical safety pharmacology services for the assessment of new drug candidates in order to guide preclinical in vivo toxicity studies and help design clinical studies.

An overview of the multidisciplinary integration required to evaluate the safety profile of a new chemical entity (NCE) in Safety Pharmacology. Figure 1. An overview of the multidisciplinary integration required to evaluate the safety profile of a new chemical entity (NCE) in Safety Pharmacology. (Pugsley, M. K., et al., 2008)

Creative Biolabs provides professional safety pharmacology services for safety assessment of drug research and development thus to deal with data reproducibility crisis which is a big obstacle for drug research and development and may lead to failure and high risk of investment. With our comprehensive safety pharmacology studies, we can drive forward and speed up your drug discovery and development process.

With expert scientists and advanced equipment, Creative Biolabs has the ability to design and optimize a panel of both GLP and non-GLP safety assessment assays. Our safety pharmacology facilities feature dedicated telemetry suites, surgical pharmacology capabilities and custom-built cardiovascular laboratories that allow for remote observation of the animals without disrupting data collection.

Creative Biolabs offers the following safety pharmacology services:

Core Battery and Follow-up Studies

The regulatory guidelines require core battery studies to analyze the effects of drugs on cardiovascular, respiratory and central nervous system functions before first administration to humans. Follow-up studies aim to provide additional knowledge or deeper insights.

Core Battery Studies Follow-up Studies
Cardiovascular System
  • Blood pressure
  • Heart rate
  • Electrocardiogram
  • hERG safety assay
  • Cardiac output
  • Ventricular contractility
  • Vascular resistancee
  • Cardiovascular responses
Respiratory System
  • Respiratory rate
  • Tidal volume
  • Hemoglobin oxygen saturation
  • Other measures of respiratory function
  • Airway resistance,
  • Compliance
  • Pulmonary arterial pressure
  • Blood gases
  • Blood pH
Central Nervous System
  • Functional observation battery (FOB)
  • Motor activity
  • Behavioral changes
  • Coordination
  • Locomotion
  • Sensory/motor reflex responses
  • Body temperature
  • Behavioral pharmacology
  • Learning and memory
  • Ligand-specific binding
  • Neurochemistry
  • Visual
  • Electrophysiology

Supplemental Studies

When potential adverse effects raise concern for human safety, supplemental studies are used to evaluate undesirable pharmacodynamic effects on organ system functions not addressed by the core battery and follow-up studies.

Supplementary Studies
Renal/ Urinary System
  • Urinary volume
  • Specific gravity
  • Osmolality
  • pH
  • Fluid/electrolyte balance
  • Proteins
  • Cytology
  • Blood chemistry determinations
Autonomic Nervous System
  • Ligand-specific and receptor binding
  • Baroreflex testing
  • Heart rate variability
  • Neurochemistry
  • Sleep/circadian rhythm
Gastrointestinal System
  • Gastric secretion
  • Gastrointestinal injury potential
  • Bile secretion
  • Transit time in vivo
  • Ileal contraction in vitro
  • Gastric pH measurement and pooling
Other Organ Systems
  • Immune functional profiling
  • Skeletal muscle

Creative Biolabs has a dedicated assay development team that will work closely with you to design customized assays. Our service will meet your specific needs fast at extremely competitive prices. If you need more information, please feel free to contact us at anytime. We look forward to working with you to help your drug research and development project succeed.

Reference

  1. Pugsley, M. K., et al., 2008. Principles of safety pharmacology. British journal of pharmacology, 154(7), pp. 1382-1399.
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