How ADME Studies Contribute To Drug Development
Production facilities and regulators in the medical industry know that drug testing needs to go beyond just effectiveness. To protect the health and well-being of customers in this space, businesses have had to withdraw pharmaceuticals from the market for toxicity concerns or unexpected drug interactions.
Medicine is a complicated field, and even a seemingly precise treatment can have unexpected side effects that make the product not worth the risk. ADME studies aim to integrate this testing directly into the discovery and development process. What is ADME, and how does it relate to similarly vital studies like toxicology, drug metabolism, and pharmacokinetics?
An Overview of Pharmacokinetics and Drug Metabolism
Before we dive into ADME, we need to cover the relationship between ADME and DMPK. These related studies in Drug Metabolism (DM) and Pharmacokinetics (PK) help medical research companies determine which drug candidates are worthy of further investigation.
Drug metabolism looks at how the body processes drugs into other compounds, primarily in the liver with drug-modifying enzymes (DME). These studies are particularly interested in whether the final products are potentially toxic.
What is a PK study? Pharmacokinetics measures how much of the drug is present throughout all parts of the body over time. PK gives deeper insight into how the pharmaceutical affects the patient and provides a benchmark to determine optimal dosage.
Understanding the Requirements For ADME, PK/TK, and DM Studies
So what Is ADME in pharmacology? ADME is a medical acronym that covers several essential parameters drug companies analyze during pharmaceutical development. You might hear of it as ADMET, which adds another critical step, toxicology.
- Absorption determines how quickly and efficiently the body can move the drug from the administration area into the bloodstream. The technical term is bioavailability. Absorption depends on the drug’s properties, including molecule size, ionization, solubility, and concentration.
- Distribution is the rate and extent the human body can distribute a single dose of drug around the body. In addition to the bloodstream, pharmaceuticals often pass through body tissues to reach the target site.
- Metabolism involves the mechanism the body uses to process the drug. As the medicine passes through bodily organs, metabolic enzymes break down the agent accordingly. This aspect looks at the final products of drug metabolism and determines whether they’re toxic.
- Elimination occurs after the drug has performed its purpose. Organs like the lungs and kidneys remove the substance through sweat, saliva, excrement, and various other methods also called elimination pathways.
- Toxicology studies the potentially toxic effects on organs and other bodily systems. Toxicokinetics (TK) compares the expected level of toxicity with the amount of exposure to a specific drug.
Why Are ADME Studies Vital To Drug Development?
Because of how important ADME studies are to drug safety, these processes often occur early in the discovery process and are essential for regulatory approval. For instance, a drug candidate must pass these tests to continue on to later clinical programs.
ADME and pharmacokinetic studies will be necessary whenever a company wants to file for an Investigational New Drug (IND), New Drug Application (NDA), or a Biologics Licensing Application (BLA) from the FDA.
While FDA guidelines allow both in vitro and in vivo testing for ADME studies, only the latter method can evaluate pharmacokinetic properties. The FDA produces various guidelines to help the industry verify drug safety and efficacy. A few examples include:
- Safety Testing of Drug Metabolites
- In Vitro Metabolism and Transporter-Mediated Drug-Drug Interactions Studies
- Clinical Drug Interaction Studies
- General Good Laboratory Practices for Nonclinical Laboratory Studies
Some testing conducted under the supervision of the Association of Assessment and Accreditation of Laboratory Animal Care (AAALAC) involves laboratory animals like rodents. If more detailed PK data is necessary, primates may be the test subjects for bioavailability, distribution, and exposure studies.
Stay Up to Date with CfPIE’s ADME Training Course
ADMET and PK studies play major roles in drug discovery and production, verifying exactly how the human body absorbs, processes, and excretes drug compounds. Therefore, companies must pay attention to these studies to choose suitable research candidates for testing and to verify compliance with FDA guidelines.
Whether you’re a team leader, you’re involved in preclinical studies, drug development process, or a clinical researcher, learning more about these vital studies is paramount to your success in future pharmaceutical development.
Are you looking to improve your knowledge of ADME, PK/TK, and drug metabolism? We recommend registering for:
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