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Related Concept Videos

Drug Administration and Therapy Phases: Overview01:26

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...
Clinical Trials: Overview01:11

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...
Preclinical Development: Overview01:28

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...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

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).
Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

Biopharmaceutical Factors Influencing Drug Product Design: Overview

Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though pharmacologically...

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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
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An industry statistician's perspective on PHC drug development.

Jane Fridlyand, Ru-Fang Yeh, Howard Mackey

    Contemporary Clinical Trials
    |May 8, 2013
    PubMed
    Summary

    Drug development costs are rising due to failed trials. Focusing on targeted treatments with predictive biomarkers offers a more efficient path for personalized healthcare (PHC).

    Keywords:
    BiostatisticianDiagnostic hypothesisDrug developmentPHC

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    Area of Science:

    • Biopharmaceutical industry
    • Clinical trial design
    • Personalized medicine

    Background:

    • Drug development is increasingly costly and time-consuming, with high failure rates in traditional clinical trials.
    • A significant portion of this cost is attributed to lengthy, expensive, and unsuccessful drug trials.
    • The pharmaceutical industry faces challenges in optimizing return on investment for drug development.

    Purpose of the Study:

    • To review industry approaches and challenges in drug development strategies that incorporate predictive biomarkers.
    • To outline concepts of co-development for novel therapeutics and diagnostics.
    • To present guiding principles for personalized healthcare (PHC) development.

    Main Methods:

    • Review of industry perspectives on drug development strategies.
    • Discussion of co-development concepts for therapeutics and diagnostics.
    • Examination of statistical, strategic, regulatory, and operational challenges in PHC development.

    Main Results:

    • Incorporating predictive biomarkers into clinical programs offers a strategy to improve drug development efficiency.
    • Co-development of therapeutics and diagnostics is essential for targeted treatments.
    • Personalized healthcare (PHC) development requires new strategies and approaches.

    Conclusions:

    • Targeted treatments with predictive biomarkers can enhance clinical benefit in specific patient populations.
    • The co-development of novel therapeutics and diagnostics is crucial for the success of personalized medicine.
    • Addressing statistical, strategic, regulatory, and operational challenges is key for effective PHC drug development.