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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...
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Antipsychotic drugs are a crucial treatment method for acute and chronic psychoses, bipolar illness, and behavioral disorders. The selection of these drugs depends on several factors, including the state of the disease, clinical judgment, possible drug interactions, and the patient's sensitivity to adverse effects. In immediate scenarios, such as delirium and dementia, short-term treatment with low doses of high-potency typical or atypical agents can effectively manage symptom exacerbation.
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The tonicity of a solution determines if a cell gains or loses water in that solution. The tonicity depends on the permeability of the cell membrane for different solutes and the concentration of nonpenetrating solutes in the solution within and outside of the cell. If a semipermeable membrane hinders the passage of some solutes but allows water to follow its concentration gradient, water moves from the side with low osmolarity (i.e., less solute) to the side with higher osmolarity (i.e.,...
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Kidney Procurement in a Preclinical Large Animal Model
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Advancing Pharmacotherapy Development from Preclinical Animal Studies.

Mark Egli1

  • 1Division of Neuroscience and Behavior, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA. mark.egli@nih.gov.

Handbook of Experimental Pharmacology
|January 29, 2018
PubMed
Summary

Predictive animal models for alcohol use disorder (AUD) medications are influenced by literature biases. Despite limitations, these models identify effective drugs and novel targets for AUD pharmacotherapy.

Keywords:
Alcohol use disorderPharmacotherapyPreclinical modelsTranslational research

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Area of Science:

  • Pharmacology
  • Neuroscience
  • Philosophy of Science

Background:

  • Animal models are crucial for assessing drug efficacy and guiding clinical development.
  • Challenges in developing predictive preclinical models for alcohol dependence (AD) include a lack of clear effective-ineffective drug categories and literature biases.
  • The philosophy of science concept of analogical argument is used to evaluate the plausibility of preclinical models.

Purpose of the Study:

  • To discuss how biases and categorization issues affect the development of predictive preclinical models for alcohol dependence (AD).
  • To evaluate the utility of excessive alcohol drinking models in supporting the plausibility of clinical pharmacotherapy for AUD.
  • To advocate for a translational approach integrating preclinical models and human studies for drug development.

Main Methods:

  • Review of preclinical models for alcohol dependence (AD).
  • Application of analogical argument from philosophy of science to assess model validity.
  • Discussion of specific drug classes investigated in preclinical models, including GLP-1 receptor agonists, phosphodiesterase inhibitors, and others.

Main Results:

  • Excessive alcohol drinking models, despite not being perfectly discriminative, are sensitive to clinically effective medications.
  • These models have identified numerous novel molecular targets for potential AD medications.
  • Several drug classes with clinically approved medications show promise based on preclinical data.

Conclusions:

  • Preclinical models of excessive alcohol drinking support the potential efficacy of pharmacotherapies for alcohol use disorder (AUD).
  • A translational strategy, combining congruent preclinical models with human laboratory studies, is recommended for drug evaluation.
  • Further research should focus on hypothesis-driven interventions to maximize the impact of validated pharmacotherapeutic effects.