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Clinical Trials

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...

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...

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...

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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...

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...

Bioequivalence studies: Biowaivers

Bioequivalence studies: Biowaivers

In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...

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Related Experiment Video

Updated: Jul 9, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

Gateways to clinical trials.

M Bayes¹, X Rabasseda, J R Prous

¹Prous Science, Barcelona, Spain. mbayes@prous.com

Methods and Findings in Experimental and Clinical Pharmacology

|November 28, 2007

Summary

This study provides a comprehensive list of novel therapeutic agents, including small molecules, biologics, and radiopharmaceuticals, for various diseases. The findings highlight advancements in drug discovery and development across multiple medical fields.

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In Silico Clinical Trials for Cardiovascular Disease

In Silico Clinical Trials for Cardiovascular Disease

Published on: May 27, 2022

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Last Updated: Jul 9, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

In Silico Clinical Trials for Cardiovascular Disease

In Silico Clinical Trials for Cardiovascular Disease

Published on: May 27, 2022

Area of Science:

Pharmaceutical Sciences
Drug Discovery and Development
Biotechnology

Context:

The landscape of therapeutic agents is rapidly evolving, with continuous innovation in drug discovery.
A wide array of novel compounds, including small molecules, biologics, and radiopharmaceuticals, are under investigation.
These agents target diverse pathological pathways and disease indications.

Purpose:

To catalog and present a broad spectrum of emerging therapeutic agents.
To provide an overview of the current pipeline of investigational drugs.
To serve as a reference for researchers and clinicians in the field of pharmacotherapy.

Summary:

The abstract lists numerous novel therapeutic agents, encompassing small molecules like (-)-Epigallocatechin gallate and Abiraterone acetate, biologics such as Adalimumab and Nivolumab, and radiopharmaceuticals like Yttrium 90 (90Y) ibritumomab tiuxetan.
These agents represent diverse therapeutic classes and are being developed for a wide range of conditions, including cancer, autoimmune diseases, and infectious diseases.
The compilation reflects the ongoing efforts in medicinal chemistry, molecular biology, and nuclear medicine to address unmet medical needs.

Impact:

Facilitates a broader understanding of the current therapeutic development pipeline.
Supports strategic decision-making in pharmaceutical research and investment.
Accelerates the identification of potential therapeutic candidates for specific disease areas.