Info

2000 4000 6000 8000 10000 Plasma Concentration (ng / mL)

Fig. 6.13. Therapeutic Windows vs. Therapeutic Index

—Activity-toxicity

Therapeutic window Target Concentration

State of patient

Demographics Disease states

Maintenance Dose D/t = CL/F.Ctarget

Maintenance Dose D/t = CL/F.Ctarget

Loading Dose D = Vd /F'Ctarget

Management of therapy

Multiple drug therapy Convenience Compliance Cost

Pharmacokinetics

ADME Route of administration Dosage form

Loading Dose D = Vd /F'Ctarget

Management of therapy

Multiple drug therapy Convenience Compliance Cost

Fig. 6.14. Determinants of a Dosage Regimen r Discovery o Non GLP

c Several compounds-high volume r Development c GLP

5> Toxicology species

> Pharmacology (non-GLP) species 5> Human r Methods c Separation

> GC, HPLC c Detection

> MS, ELISA, fluorescence, UV r Sensitivity and specificity r Assay validation

Fig. 6.15. Bioanlytical Method Development shown in Figure 6.14, that is, the determinants of a dosage regimen. One consideration includes the therapeutic window and target concentration that relate both efficacy and safety of the NCE (i.e., its pharmacological response and toxicity to concentrations). Another consideration is how the body acts on the drug and its dosage form, the essence of PK, which helps to derive both loading and maintenance dose regimens. A third consideration is that of the demographics and clinical state of the patient. A fourth consideration includes all other factors such as patient total therapeutic regimen and multiple drug management including drug-drug interactions, convenience, compliance and cost, and so forth. All of these determinants are interrelated and interdependent. The loading doses or maintenance doses can be calculated based on the formulae in this figure using clearance (CL), dose (D), drug distribution (V), and fraction absorbed (F) values.

Was this article helpful?

0 0
Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

Get My Free Ebook


Post a comment