How are biologics metabolized?
In general, biologics are metabolized/catabolized into small peptide fragments or amino acids that are ready for renal excretion or recycling into protein synthesis. The rate of metabolism for biologics is compound- or modality-dependent.
What are the most commonly utilized routes of administration for biologics and what is the pharmacokinetic basis for these routes?
Biologics are mainly delivered by parenteral administration, such as intravenous (IV), subcutaneous (SC) and intramuscular (IM) injections. Because of their large molecular size, biologics are absorbed slowly, with a longer time to peak concentration (Tmax) following SC and IM administration than small molecules.
How are biologics excreted?
The biologics with a molecular weight <69 kDa are mainly cleared by renal excretion. Therefore, the clearance of these biologics can be compromised in patients with renal impairment.
What are the small molecule drug discovery processes?
Small-molecule drugs can be developed from leads derived from rational drug design or isolated from natural resources. A target-based drug discovery project usually includes target identification, target validation, hit identification, hit to lead and lead optimization.
What is pharmacokinetics in pharmacology?
Pharmacokinetics is currently defined as the study of the time course of drug absorption, distribution, metabo- lism, and excretion. Clinical pharmacokinetics is the application of pharmacokinetic principles to the safe and effective therapeutic management of drugs in an individual patient.
What is the difference between pharmacodynamics and pharmacokinetics?
In simple words, pharmacokinetics is ‘what the body does to the drug’. Pharmacodynamics describes the intensity of a drug effect in relation to its concentration in a body fluid, usually at the site of drug action. It can be simplified to ‘what the drug does to the body’.
What is the difference between pharmacokinetics and toxicokinetics?
Pharmacokinetics generally deals with doses that are in a therapeutic range. Thus common dose ranges will include the no pharmacologic effect level on the low end, and the maximum pharmacologic effect level on the high end. Toxicokinetics is the study of systemic exposure during toxicological experiments.
What is pharmacokinetics process?
The pharmacokinetic process is concerned with the absorption, distribution, and elimination (by metabolism and excretion) of drugs. It is evident that drug molecules have to pass many structural and metabolic barriers.
What are the four principles of pharmacokinetics?
There are four main components of pharmacokinetics: liberation, absorption, distribution, metabolism and excretion (LADME). These are used to explain the various characteristics of different drugs in the body.
What are the pharmacokinetic and pharmacodynamic characteristics of biologics?
Biologics, specifically monoclonal antibody (mAb) drugs, have unique pharmacokinetic (PK) and pharmacodynamic (PD) characteristics as opposed to small molecules. Under the paradigm of model-based drug development, PK-PD/clinical response models offer critical insight in guiding biologics development …
What is a biologic drug?
Application of pharmacokinetics-pharmacodynamics/clinical response modeling and simulation for biologics drug development Biologics, specifically monoclonal antibody (mAb) drugs, have unique pharmacokinetic (PK) and pharmacodynamic (PD) characteristics as opposed to small molecules.
Are biologics a victim of drug-drug interaction (DDI)?
Clinical investigations on biologics as a victim of DDI include the impact of altered target protein levels by the concomitant medication on the clearance of therapeutic proteins, the displacement of therapeutic proteins from binding proteins, and the modulation of Fcγ receptor expression.
Can PK-PD/clinical response models guide biologics development?
Under the paradigm of model-based drug development, PK-PD/clinical response models offer critical insight in guiding biologics development … Biologics, specifically monoclonal antibody (mAb) drugs, have unique pharmacokinetic (PK) and pharmacodynamic (PD) characteristics as opposed to small molecules.