Behind every drug in the market—whether prescription or over-the-counter—are years of painstaking research and development. A 2024 study of over 80 projects published in The Lancet Regional Health – Europe revealed that the development time, from first-in-human clinical trials to authorization for public use, ranged from 8 months to 18.6 years. (1)
It’s fortunate that some drugs, namely COVID-19 vaccines and later medications, enjoyed rapid development times due to the pandemic.
Regardless, rushed drug development is a risky venture under normal circumstances. Not only does it compromise people’s health when released, but it also risks setting back medical research years.
Naturally, pharma logistics can’t distribute drugs not approved for public use, so a smooth development cycle is a must. Key to rolling out effective medicines is pharmacokinetic (PK) and pharmacodynamic (PD) data analysis, often referred to as PK PD analysis.
Demystifying PK PD Analysis
To understand the impact of PK PD analysis on pharma logistics, it’s important to break it down in layman’s terms.
| Pharmacokinetics PK is concerned with a drug’s path from its entry point (e.g., injection, swallowed as a pill) to the ailing part of the body. In drug development, PK focuses on improving the drug’s efficacy and lowering its toxicity. (2) | Pharmacodynamics PD begins when the drug finally reaches its destination, called the site of action. It explores the behavior the drug exhibits when it binds with receptors in the target tissue and delivers its concentration. (2) |
For example, a person suffering from a headache takes a painkiller. PK describes how the painkiller travels from the entry point, usually the mouth, to the brain via the bloodstream. Once it arrives, PD explores how the medication binds with receptors in the brain to bring lasting pain relief. Basically, PK and PD define the drug.
Analyzing PK PD data effectively can mean the difference between a lifesaving drug and an ineffective one. Books on the subject cover many subprocesses, from creating drug effect models to using various statistical measures to assess the drug’s efficacy.
Mastering PK PD analysis is no walk in the park. However, doing its many subprocesses by the book can have positive implications for pharma logistics, namely in the areas discussed below.
1. Cold Chain Management
Developing lifesaving medication is one thing, but ensuring it’s still effective when it gets to the recipient is another. While awaiting distribution, drugs need to be kept in ideal storage conditions and at exact temperatures to maintain their efficacy.
Vaccines, for instance, rarely work with a single shot; they require boosters to maintain a patient’s immunity from a specific disease. This is due to the nature of the vaccines, which are either live-attenuated (weakened live pathogen) or non-live (inactivated pathogen). A healthy immune system will respond, but boosters will teach it to maintain that response.
PK PD analysis is instrumental in determining how many follow-up shots a specific vaccine will require. Between the primary vaccine and its boosters, pharma logistics need to allot enough cold chain management storage. The analysis also determines other storage best practices like avoiding refreezing unused vaccines.
2.Drug Serialization
Serialization is the practice of labelling individual pharmaceutical products with a unique identifier to better monitor their distribution. It was born out of a rise in substandard and falsified drugs over the past decade.
The World Health Organization (WHO) estimates that a tenth of drugs in circulation in low and middle-income countries don’t meet quality requirements. In 2016, it received reports of fake antimalaria drugs going around in several Southeast Asian countries. As such drugs clearly don’t work, consumers end up footing a costly bill for additional treatment. (3)
PK PD analysis can be just as important in medical forensics, particularly in assessing counterfeit medication. Countering the growing sophistication of producing these fakes are technologies used in clinical studies such as X-ray fluorescence spectroscopy, liquid chromatography, and gas chromatography paired with mass spectrometry.
As soon as the results confirm that fake drugs are in circulation, pharma logistics can help cease their distribution or recall those already in the market. Serialization has been shown to be more efficient in tracking products than the older batch and lot system.
3. Procurement and Inventory Control
Antimicrobial resistance (AMR) continues to be a major health threat worldwide, claiming the lives of almost five million people in 2023 (as per WHO data). This occurs when typical antibiotics are shown to be ineffective against the pathogens they’re designed to eliminate. As a result, a patient’s treatment options become fewer and less effective. (4)
Common causes of AMR range from improper antibiotic use to poor infection control. A study published in the Bulletin of the WHO found that an inefficient supply chain is also a contributor. A scarce supply of antibiotics not only disrupts a person’s treatment but also risks counterfeits and ineffective alternatives filling the gap. (5)
Healthcare systems are responsible for ensuring a person’s treatment can be completed. In the case of antibiotic use, they should be able to assess if a patient’s condition warrants it and, if so, how often they must take it. AMR relies on interruptions in antibiotic treatment to give pathogens time to boost their resistance against the drug.
PK PD analysis, combined with statistical techniques, is key to this endeavor. It works by finding out the optimal dose requirement to reduce the likelihood of AMR and increase the chance of clinical success. It’s worth noting that, unlike other drugs, antibiotics deliver the minimum drug concentration (not low) necessary to inhibit microbial growth.
With crucial PK PD information, pharma logistics will then be responsible for several things. Aside from ensuring an ample supply of antibiotics, it also needs to establish local supply and procurement chains, mobilize the right workforce for the job, and maintain an effective antimicrobial stewardship program.
Conclusion
Supply chain management for pharmaceuticals can’t happen without ensuring the drug’s effectiveness through PK PD analysis. It exerts a significant influence on how pharma logistics entities approach drug storage and distribution, whether under normal circumstances or emergencies on a global scale.
References:
1. Möhrle J. How long does it take to develop a new drug? [Internet]. The Lancet Regional Health — Europe. 2024 [cited 2025 Aug 20]. Available from: https://www.thelancet.com/journals/lanepe/article/PIIS2666-7762(24)00165-0/fulltext
2. ASHP. Introduction to Pharmacokinetics and Pharmacodynamics [Internet]. www.ashp.org. Available from: https://www.ashp.org/-/media/store%20files/p2418-sample-chapter-1.pdf
3. World Health Organization. Substandard and falsified medical products [Internet]. Who.int. World Health Organization: WHO; 2024. Available from: https://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products
4. World Health Organization. Antimicrobial Resistance [Internet]. World Health Organization. World Health Organization; 2023. Available from: https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance
5. Kamere N, Rutter V, Munkombwe D, Aywak DA, Muro EP, Kaminyoghe F, et al. Supply-chain factors and antimicrobial stewardship. Bulletin of the World Health Organization [Internet]. 2023 Jun 1;101(6):403–11. Available from: https://pubmed.ncbi.nlm.nih.gov/37265674/
Article and permission to publish here provided by Claire Glassman. Originally written for Supply Chain Game Changer and published on September 10, 2025.
Images and permission to publish here provided by Claire Glassman.