Decision-making in early clinical drug development

  • What are the 4 stages of drug development process?

    Drug development can be divided into four phases: discovery, preclinical studies, clinical development and market approval..

  • What are the decision points in drug development?

    The commercial success of a drug hinges mostly on five key decision points made during the development life cycle.
    They include choosing the appropriate 1) indication, 2) dose, 3) patient population, 4) study design and 5) total evidence package..

  • What is early development in drug development?

    Early and preclinical drug development is a complex, regulatory and strategy-driven process.
    The most important element of the preclinical process is to select the best new molecular entities to enter into the clinical trials and to limit failure in full development..

  • Clinical Development helps determine the safety and efficacy of medications and treatments intended for human use.
    PharmDs will lead teams and manage operational aspects throughout the clinical trial, and facilitate the development of clinical documents.
  • Early clinical development initiates testing in humans, corresponding to Phases 1 and 2a exploratory studies.
    The investigational product is administered to small groups of healthy volunteers or patients to assess safety and to determine a safe dosing range.
  • There are 3 main phases of clinical trials – phases 1 to 3.
    Phase 1 trials are the earliest phase trials and phase 3 are later phase trials.
    Some trials have an earlier stage called phase 0, and there are some phase 4 trials done after a drug has been licensed.
This paper illustrates an approach to setting the decision framework for a study in early clinical drug development. It shows how the criteria for a go and 

Can a decision framework lead to a three-outcome approach?

The framework can lead to a three-outcome approach by i … This paper illustrates an approach to setting the decision framework for a study in early clinical drug development.
It shows how the criteria for a go and a stop decision are calculated based on pre-specified target and lower reference values.

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How are treatment decisions based on side effects?

In clinical practice, besides treatment assignment based on tumour biopsy-based genomic testing, patient-level treatment decisions (like dose adjustments, switch to new therapy) are often based on side effects and response to treatments, or in specific cases on pharmacokinetics [ 40, 41 ].

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How is decision-making made in early clinical drug development?

Decision-making in early clinical drug development This paper illustrates an approach to setting the decision framework for a study in early clinical drug development.
It shows how the criteria for a go and a stop decision are calculated based on pre-specified target and lower reference values.

,

What is pharmaceutical development?

Pharmaceutical development refers to all the different tasks undertaken to transform the drug substance identified as a candidate during the discovery phase into a dosage form that is able to reliably deliver the drug into the body in a safe and reliable way.
Designing a formulation can be as equally time consuming and complex as drug discovery.


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