Safety and efficacy to limit adverse effects
The main aim of drug development is to get a compound that has a therapeutic effect into the form of a medicine we can dose to patients that is safe and effective. A drug must reach the site of action in a quantity sufficient to exert its pharmacological effects, and be eliminated in a reasonable timeframe. ADME stands for absorption, distribution, metabolism and excretion of chemicals and drugs and is used to define the drug’s impact in a human body. ADME test results can be used to predict how the drug will behave in the body and to assess its potential for adverse interactions with other drugs.
Characterization of ADME properties help to explore and explain how pharmacokinetic processes happen, so as to provide safety considerations of a new drug on which risk-based assessments can be made. ADME studies are key at each preclinical stage of the drug discovery process, from high throughput screening (HTS), hit identification, lead optimization and finally the selection of a candidate molecule for clinical development. In discovery and lead optimization, drug developers may make chemical modifications to drug candidates to optimize ADME properties. An early characterization of these properties will ensure appropriate selection of compounds with acceptable pharmacokinetic characteristics to guarantee efficacy while limiting adverse effects and optimizing development time. Bioanalytical assays that reliably quantify biotherapeutics and biomarkers in biological samples play pivotal roles in drug discovery and development.
Medicilon’s DMPK&BA department offers our clients a broad spectrum of high quality services in the areas of in vitro ADME, in vivo pharmacokinetics and bioanalytical services, for both small and large molecule drugs, such as proteins, antibodies, oliogonucleotides, ADC and new modalities. We have available all common laboratory animal species such as non-human primates, canines, minipigs, mice, rats, rabbit and etc.