Safety & Efficiency Evaluation

Safety aspects have become an outstanding issue in the process of drug discovery and development. The International Conference on Harmonization (ICH) has founded a Safety Pharmacology Working Group. Exposure of a drug to the body by pharmacokinetic studies on absorption, distribution, metabolism and excretion has to be investigated at an early stage of development and can contribute to the selection of a compound for development. Toxicology experienced major achievements by the introduction of new methods, e.g., in silico methods, toxicogenomics and toxicoproteomics.

Safety Pharmacology

It is important to adopt a rational approach when selecting and conducting safety pharmacology studies. Vital organs or systems, the functions of which are acutely critical for life, such as the cardiovascular, respiratory and central nervous systems, are considered to be the most important ones to assess in safety pharmacology studies. MedAI's experimental platform provides in vitro Safety Pharmacology services that may be used throughout the drug discovery process to help de-risk your drug candidates.

Cardiac Liability

A certain proportion of compounds in preclinical drug development show a certain degree of cardiovascular risk. Cardiovascular diseases caused by drugs limit the use of many successful clinical treatments. Most drug-induced cardiovascular complications include obvious cardiac dysfunction, hypertension, ischemia, and arrhythmia. Huge manpower and material resources have been input throughout the development of new drugs to identify adverse effects of the cardiovascular system and minimize the risk to patients. Specific assessment of the human hERG channel is required in the ICH S7B.

Ion Channels Test Panels CiPA
  • hERG (Ikr, Kv11.1)
  • Cav1.2
  • Kv1.5, Kv4.3
  • KCNQ1/mink/Kv7.1
  • Kir2.1
  • Nav1.5
  • HCN1&HCN4
  • Other Ion Channels
  • CiPA Cardiac Channel Assays
  • CiPA In silico Modeling
  • CiPA Translational Assays
Cardiomyocte Functions Cardiac in vivo Assays
  • Action Potential Properties
  • Calcium Transient in Cardiomyocytes
  • QT Service Using Langendorff Perfused Heart
  • QRS, QT Waves Detection by ECG

Neuronal Activity

During the preclinical safety assessment, it is also necessary to test the effect of the candidate drug on the central nervous system. Merely detecting neuronal survival or neuronal morphological changes is not enough to evaluate the safety of candidate drugs. It also requires a comprehensive evaluation of basic neuronal activity and neurotransmission functions. Neuronal excitability measurements at the individual cell level characterize the effects of pharmacological agents on different neuronal cell types, receptors, ion channels or neurotransmitter systems.

Basic Neuronal Activity Neurotransmission Functions
  • Action Potential Properties Assay
  • NMDA/AMPA Ratio Test
  • Calcium Signaling Test
  • Customized Electrophysiological Test
  • sEPSC/sIPSC Recordings
  • fEPSP / Populational Spikes Recordings
  • LTP & LTD Formation or Deficit Detection
Neuronal in vivo Assays Animal Behavior Tests
  • In vivo Extra-cellular Recordings/Whole-cell Patch-clamp Recordings
  • Continuous Telemetric EEG Recordings
  • Spontaneous Locomotor Functions
  • Cognitive Functions
  • Anxiety-Depression and Social Interaction Evaluation
  • Assays for Neuropsychiatric Disorders

Profiling Panels

Profiling panels can be used extensively throughout the drug discovery process, to achieve optimal specificity of new drugs and predict clinical adverse effects. Our standard panels include binding and functional panels for identifing undesirable adverse drug reactions (ADRs), lead optimization and candidate selection. Ligand binding or enzyme assay data suggesting a potential for adverse effects, should be selected and designed accordingly, which is pointed out in the ICH S7A for Human Pharmaceuticals.

Customized Safety Pharmacology Profiling

We can also provide customized safety pharmacology profiling services according to the specific needs of your drug discovery program.

Our experienced team of scientists in MedAI is dedicated to advancing your program successfully at any stage of drug discovery and development. Our services are cost-effective and high quality with reproducible data and flexible solutions.

Online Inquiry

Please submit a detailed description of your project. We will provide you with a customized project plan to meet your research requests. You can also send emails directly to inquiry@protheragen.com for inquiries.

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