A blended strategy using competitive and regulatory models

T P Weil1, R M Battistella

  • 1Bedford Health Associates, Inc., Management Consultants for Health & Hospital Services, Asheville, NC, USA.

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The Two-State Receptor Model01:29

The Two-State Receptor Model

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The binding affinity of a drug determines its interaction with one...
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Drug Control Governance: Regulatory Bodies and Their Impact

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Pharmacodynamic Models: Overview01:27

Pharmacodynamic Models: Overview

Pharmacodynamic (PD) responses describe the interaction between a drug and its biological target, culminating in a physiological effect. These responses can be classified into different types: continuous variables, such as blood glucose levels; categorical outcomes, like survival rates; and time-to-event metrics, such as disease progression. Understanding and modeling PD responses are critical for optimizing drug efficacy and safety.PD models describe the relationship between drug concentration...
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Pharmacodynamic Models: Direct Effect Model and Indirect Response Model

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Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).