The safety information about the drug remains limited during its pre-authorization process which results in many consequences.
For this, the World Health Organization (WHO) has implemented Programme for International Drug Monitoring (PIDM), which is a network of >150 countries for monitoring the ADRs for enhancing the safer and more effective use of drugs.
Also, it is necessary to notify all AEs related to drugs to the ethics committees (responsible for ensuring human research is carried out in an ethical manner).
All safety issues of the drug are reviewed by Drug Safety Monitoring Boards.
For doing this, the sponsor needs to follow below main elements:
Phase IV Studies: Post-authorisation safety and efficacy studies which include either disease management studies or pharmacoepidemiology studies.
In PV industry, most of the operations, e.g., detecting and reporting ADRs, assessment of its seriousness and causal relationship with the suspected drug, coding of adverse events in technical terms, preparing safety reports of individual cases, depending upon the human interventions which consume a lot of time.
For such situation, an effort by regulatory authorities is the discussion related to the machine learning (ML) technology which could support PV because this technology requires no translator to translate the codes of ADRs used under PV system and it can learn by its own without human intervention.
In drug development, it can enhance the stages of the drug discovery process (chemical structure of the drug, identification of the effect of the drug in both preclinical and clinical trials, etc.)
by analyzing and interpreting the biomedical data from research experiments to predict the ADRs of the drug.
The AI-led PV system can automatically extract and code ADR data from multiple sources to reduce case processing effort.
By adopting such a knowledge-driven idea, there is an evident rise in the journals, media, and articles that some pharmaceutical companies tie-up with IT companies and launch AI-based solutions for drug safety.
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The global Pulmonary Arterial Hypertension (PAH) Market size was valued at USD 5.0 billion in 2015 and is anticipated to reach USD 8.7 billion by 2025.
PAH occurs when the pulmonary arteries thicken or grow rigid. These drugs work by opening the blood vessels in the lungs to allow blood to flow easily. These drugs have superiority over existing therapy options with respect to the therapeutic efficacy, route of administration, and side-effects. Geographically, PAH market is segmented into North America, Europe, Asia Pacific, Latin America, MEA, and Rest of the World.
