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ProtoMedical BioSciences, Inc. provides comprehensive clinical research support for pharmacokinetic studies in drug development. The objective of such PK studies is to evaluate the absorption, distribution, metabolism and excretion (ADME) of a new drug candidate.
Information gathered during these studies include PK parameters, such as Cmax (maximum concentration), Tmax (Time to Cmax), volume of distribution at steady state (Vdss), area under the curve (AUC, exposure), steady state plasma concentrations, accumulation ratio, half life, clearance, bioavailability, linear or nonlinear PK, time dependent PK (auto-induction), plasma protein binding, metabolite identification and related pharmacokinetics.
PK studies supported include:
1. Single Ascending Dose (SAD)
2. Multiple Ascending Dose (MAD)
3. Food Effect Studies
4. ADME Mass Balance Studies
5. Absolute/Relative Bioavailability
6. Thorough QTc Study
7. Drug Interaction Studies - Enzyme Inhibition/Induction
8. Effect of Age and Gender
9. Special Population - Hepatic Impairment
10. Special Population - Renal Impairment
11. Impact of Genetic Polymorphisms of Drug Metabolizing Enzymes
ProtoMed can produce whole sections or parts of sections, and depending on our client's needs, and add to existing files, edit, update, and prepare dossiers in paper form or as fully hyperlinked eCTDs.
ProtoMed also executes extensive pharmacokinetic profiles for bioavailability /bioequivalence (BA/BE), first-in-man, thorough QTc studies, and drug interaction studies. Specialized population pharmacokinetics, including studies in renal insufficiency and other pathophysiologic states are provided.
ProtoMed is physician-owned and operated, giving clients the benefit of in-house physician input and oversight for all pharmacokinetic, clinical research, and
medical writing projects.
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