What Are the Stages of Drug Development?

At InfinixBio, we’re deeply embedded in the drug development process, striving to bring innovative therapies from the lab bench to the bedside.

Understanding the stages of drug development highlights the challenges involved but also shows our commitment to improving healthcare through scientific breakthroughs.

Step 1: Drug Discovery

The FDA describes the first stage of drug development as the discovery phase.

Here, the focus is on identifying molecules with promising pharmacologic effects that may offer therapeutic benefits.

This stage involves extensive research to understand disease mechanisms and identify potential targets for treatment.

An animal model proof-of-concept is typically achieved at this stage.

Step 2: Preclinical Research for Drug Development

Before a drug enters the market, it undergoes rigorous preclinical research, as per the FDA. This stage ensures that only the most promising candidates move forward in the drug development process.

In vitro and In vivo Studies

Our preclinical research involves both in vitro (test tube or cell culture) and in vivo (animal model) studies.

These experiments explore how a drug interacts with biological systems.

In vitro assays allow us to observe the effects of a drug on cells or biological molecules under controlled conditions, while in vivo experiments provide insights into how a drug behaves in a living organism.

Safety and Efficacy Assessment

We meticulously investigate potential side effects and how a drug is absorbed, distributed, metabolized, and excreted (ADME).

These studies are vital for establishing pharmacokinetics (where the drug goes and how long it lasts) and pharmacodynamics (how the drugs affects the body), which inform dosing guidelines for future clinical trials.

Submitting the Investigational New Drug Application (IND)

The first phase of clinical trials begins with an Investigational New Drug (IND) application to regulatory authorities, outlining our plan for studying the drug in humans.

According to the MD Anderson Cancer Center, phase 1 is all about safety.

We start with a small group of healthy volunteers, focusing on how the drug is metabolized and its potential side effects at various doses.

Step 3: Phases of Clinical Trials

Once we’ve identified a drug candidate and navigated through the challenges of preclinical research, we begin the most critical stages of drug development: the clinical trials.

Clinical trials are where science meets human health directly, involving a series of controlled studies to ensure the safety and effectiveness of a new drug.

These trials are designed to meet stringent scientific and regulatory standards, ensuring that every step, from the initial application to the final approval, is conducted with precision and care.

The FDA outlines everything you need to know about the phases of clinical trials.

Phase 1 – Safety

The initial phase of clinical trials focuses on ensuring the safety of a new drug in a small group of healthy volunteers. This stage determines the safe dosage range and identifies any side effects.

Learn more about the transition from lab bench to human trials with InfinixBio.

Phase 2 – Efficacy

Once a drug’s safety is confirmed, the next phase assesses its effectiveness in treating a specific condition. This involves a larger group of participants to gather preliminary data on how well the drug works.

Phase 3 – Safety and Efficacy on Large Scale

This phase expands the study to an even larger group of participants to confirm the drug’s effectiveness and monitor side effects on a broad scale. It’s a critical step before a drug can be approved for general use.

Phase 4 – Post-Marketing Surveillance of Safety/Long Term Effects

After a drug is approved and available to the public, this phase involves ongoing monitoring of its safety and effectiveness over the long term. This helps identify any rare or long-term side effects and ensures the drug’s continued safety in the general population.

InfinixBio has a proven track record of overcoming lab-related challenges while guiding clients on a successful regulatory pathway. Learn more about our story.

Learn More: From Concept To Reality: The Journey Of Assay Development And Validation With InfinixBio

Ongoing: Regulatory Submission and Review

Now, we reach the regulatory submission and review stage.

This is where the collective efforts of countless scientists, researchers, and participants are compiled into a comprehensive package, ready for review by regulatory authorities.

Preparing the New Drug Application (NDA)

The New Drug Application (NDA) is our formal proposition to regulatory agencies, such as the FDA in the United States, seeking approval to market a new drug.

This comprehensive documentation must adhere to stringent regulatory guidelines and quality standards to ensure the drug is safe, effective, and ready for public use.

FDA (or Relevant Authority) Review Process

Once the NDA is submitted, the ball is in the regulatory agency’s court.

The FDA’s job is to protect public health by thoroughly evaluating the safety and efficacy of the drug. The review process can take months, involving a meticulous examination of the NDA’s components.

Addressing Regulatory Feedback

It’s common for the agency to have questions or request further data to support the application.

We must address any concerns, provide additional data, and maintain an open line of communication with the regulators.

Step 5: Post-Marketing Surveillance

Crossing the finish line of drug approval doesn’t mean our journey with drug development ends. This phase, known as post-marketing surveillance, is where we closely monitor our drug’s performance in the real world.

Monitoring Real-World Safety

Post-marketing surveillance is our window into how the drug interacts with a broader, more diverse population over a longer period.

This ongoing monitoring process helps us track any adverse events or side effects that might not have been evident during the clinical trials.

Pharmacovigilance Strategies

The World Health Organization describes pharmacovigilance as the heart of post-marketing surveillance.

This focuses on detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems.

Reporting these findings is about commitment to patient safety.

Step 6: Drug Approval and Market Access

As we approach the end of the drug development journey, two critical milestones emerge: drug approval and market access.

Regulatory Approval and Drug Licensing

Agencies like the FDA are tasked with protecting public health by carefully evaluating new drugs before they can be marketed.

Obtaining a drug license is further proof of a drug’s quality, efficacy, and safety, allowing it to be prescribed to patients.

Market Launch Strategy

Launching a new drug goes beyond achieving regulatory approval.

It involves careful planning around marketing, pricing, and distribution to ensure the drug is accessible to those who need it.

A successful market launch strategy considers the competitive landscape, patient needs, healthcare provider perspectives, and payer requirements.

Post-Approval Commitments and Responsibilities

Post-market surveillance, safety monitoring, and reporting are critical to ensure the continued safety and efficacy of our drug in the broader population.

Compliance with regulatory requirements is a continuous process that requires dedication to patient safety.

These post-approval activities help us gather valuable real-world data, allowing us to refine our understanding of the drug’s performance and impact over time.

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InfinixBio’s Contribution to Drug Development

At InfinixBio, we collaborate and partner with drug development companies; helping them to innovate in the drug development process.

We understand that drug development requires a multidisciplinary effort, which is why we actively partner with industry leaders, academic institutions, and research organizations.

Get in touch with us today. 

Together, let’s create a world where every patient has access to the treatments they need to live healthier, fuller lives.


What is drug development?

Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery.

How long does the drug development process take?

The drug development process can take many years from the initial discovery of a compound to the time it becomes available for prescription to patients.

What are the main phases of clinical trials?

Phase 1 (safety testing on a small group of healthy volunteers), Phase 2 (efficacy testing on a larger group of patients), and Phase 3 (large-scale testing to confirm effectiveness, monitor side effects, and compare with standard treatments). After approval, Phase 4 trials monitor long-term effects.

How does InfinixBio contribute to the drug development process?

As a contract research organization, we assist drug developers in navigating the regulatory approval process.

Looking for a trusted partner for your pre-clinical toxicology studies?

Our experienced lab team is here to help. Reach out today to learn more.