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Preclinical Development: Overview

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 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 Discovery: Overview

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...

Drug Administration and Therapy Phases: Overview

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...

In Vitro Drug Release Testing: Overview, Development and Validation

In Vitro Drug Release Testing: Overview, Development and Validation

In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...

Drug Regulation

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...

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Related Experiment Video

Updated: Jan 7, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

Drug Development.

Mariam M Fouad¹, Nadeen A Nagy¹, Noreen M El-Bayaa¹

¹Faculty of Medicine Port Said Univeristy, Egypt, Port Said, Port Said, Egypt.

Alzheimer'S & Dementia : the Journal of the Alzheimer'S Association

|December 26, 2025

Summary

This summary is machine-generated.

Donanemab effectively reduces brain amyloid plaques in Alzheimer's disease patients for up to 72 weeks. While generally well-tolerated at 10 mg/kg, it is linked to adverse effects requiring careful consideration.

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Developmental Toxicity Assay Based on Real-Time Monitoring of Fibroblast Growth Factor Signal Disruption in Human Induced Pluripotent Stem Cells

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Published on: October 10, 2025

Area of Science:

Neuroscience
Pharmacology

Background:

Alzheimer's disease is a progressive neurodegenerative disorder impacting cognitive function.
Current research investigates Donanemab's potential to alleviate Alzheimer's symptoms.

Purpose of the Study:

To evaluate the efficacy and safety of Donanemab in improving cognitive and behavioral symptoms of Alzheimer's disease.

Main Methods:

A systematic literature search was conducted across major databases (Cochrane, PubMed, Web of Science, SCOPUS) until December 1st, 2024.
A synthetic approach was used for data interpretation due to limitations precluding meta-analysis.

Main Results:

Donanemab at 10 mg/kg (3-5 doses) significantly reduced brain amyloid levels without reaccumulation for 72 weeks; lower doses showed no significant reduction.
Adverse effects included increased musculoskeletal disorders (arthralgia), cerebral microhemorrhage, superficial siderosis, fatigue, falls, and headaches, particularly in the intervention group.

Conclusions:

Donanemab provides rapid, robust, and sustained reduction of brain amyloid plaques.
The drug is generally well-tolerated up to 10 mg/kg but carries significant adverse effects necessitating a thorough risk-benefit assessment.