Related Experiment Video
Updated: May 29, 2026

23:56
Comprehensive & Cost Effective Laboratory Monitoring of HIV/AIDS: an African Role Model
Published on: October 31, 2010
Drug-diagnostic co-development: how to harness the value
Edward D Blair1, James A Blakemore
1Integrated Medicines Ltd, Cambridge, UK. eddie.blair@integratedmedicines.co.uk
Drug Discovery Today
|September 6, 2011
Summary
This study revisits a drug valuation model, assessing its accuracy against evolving regulatory and reimbursement landscapes. Recent case studies confirm the model
Area of Science:
- Health economics and outcomes research
- Pharmaceutical market analysis
- Drug valuation methodologies
Background:
- A prior value assessment process was established based on assumptions linking drug development and marketing to valuation.
- Significant shifts in regulatory policies and reimbursement strategies have occurred since the process was developed.
Purpose of the Study:
- To evaluate the continued validity of the initial assumptions in the value assessment process.
- To examine the impact of regulatory and reimbursement changes on drug valuation.
- To test and stratify recent cases using derived relationship models.
Main Methods:
- Review of historical assumptions in drug valuation.
- Analysis of current regulatory and reimbursement environments.
- Empirical testing of relationship models through case studies involving testing and stratification.
Main Results:
- The study assesses how the initial assumptions of the drug valuation process have performed under new market conditions.
- The relationship models derived from the value assessment process were substantiated through recent case analyses.
- The findings provide insights into the robustness of the valuation framework amidst industry changes.
Conclusions:
- The established drug valuation framework demonstrates resilience and adaptability.
- Regulatory and reimbursement shifts necessitate ongoing refinement of valuation models.
- The study validates the utility of the developed models for current pharmaceutical market assessment.
Related Concept Videos
Drug Discovery: Overview
Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
Preclinical Development: Overview
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
Clinical Trials: Overview
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Drug Product Performance: In Vitro–In Vivo Correlation
In pharmaceutical development, it's crucial to establish a predictive in vitro–in vivo correlation (IVIVC) for two or more formulations to gain a comprehensive understanding of release properties. IVIVC reduces the need for costly in vivo studies and facilitates the establishment of meaningful dissolution specifications with significant cost savings and decreased regulatory burden. Furthermore, a meaningful IVIVC should predict Cmax and AUC within 20%, aligning with FDA guidance while adhering...
Drug Administration and Therapy Phases: Overview
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
Automated Microbial Diagnostics
Automated diagnostic analyzers have transformed clinical microbiology by providing rapid and reliable methods for pathogen identification and antibiotic susceptibility testing. Among these systems, the Vitek 2 is widely used because it automates the traditionally labor-intensive processes of microbial identification (ID) and antibiotic susceptibility testing (AST), delivering standardized and timely results that are essential for effective patient care.Microbial Identification with ID CardsThe...
