The development of an effective herbal medicine doesn’t end with a promising formulation. To enter the market and ensure safe use by patients, every drug must go through a series of scientific and regulatory steps. These steps are mainly categorized into two stages: preclinical phase and clinical trials. A proper understanding of these phases is essential for researchers, entrepreneurs, and startups in the herbal pharmaceutical industry.
The development of an effective herbal medicine doesn’t end with a promising formulation. To enter the market and ensure safe use by patients, every drug must go through a series of scientific and regulatory steps. These steps are mainly categorized into two stages: preclinical phase and clinical trials. A proper understanding of these phases is essential for researchers, entrepreneurs, and startups in the herbal pharmaceutical industry.
The preclinical phase involves testing the drug candidate in the laboratory and on animals before it is tried on humans. The main goals are to assess safety, toxicity, absorption, distribution, metabolism, and excretion (ADME).
In vitro studies: Laboratory tests on cells and tissues to study the biological activity.
In vivo studies: Animal testing to assess toxicity and safety in living systems.
Pharmacokinetic and pharmacodynamic studies: Understanding how the drug behaves in the body and its mechanism of action.
Documentation for regulatory submission: Preparing comprehensive data for regulatory bodies such as the Food and Drug Administration (FDA).
In herbal medicine, standardization of extracts and identifying active compounds are among the most critical and challenging tasks at this stage.
Once preclinical results are promising and approved by regulatory bodies, the drug enters clinical trials in humans, which are conducted in four phases:
Participants: 20 to 80 healthy individuals
Goal: Assess safety and identify safe dosage range
Focus: Detect immediate side effects
Participants: 100 to 300 patients
Goal: Evaluate therapeutic efficacy and side effects
Focus: Dose-response relationship
Participants: 1,000 or more patients
Goal: Confirm efficacy and compare with standard treatments or placebo
Focus: Gather data for final regulatory approval
Goal: Monitor long-term safety and identify new applications
Timing: After the drug is available on the market
Herbal medicines pose specific challenges in both preclinical and clinical phases due to their complex nature:
Multiple active compounds vs. single-compound chemical drugs
Variability in extract quality due to plant source and processing
Need for rigorous standardization and quality control
WHO and other international bodies support tailored clinical trial designs for herbal products
Preclinical and clinical phases are the backbone of safe and effective herbal drug development. Without completing these steps, even the best formulations cannot reach patients. For innovators and startups in this field, collaboration with accelerators, research centers, and understanding regulatory requirements can greatly streamline the path from lab to market.
