Related Experiment Video
Updated: May 10, 2026
09:58
Lipidomics and Transcriptomics in Neurological Diseases
Published on: March 18, 2022
[Registries for neurological drugs landscape]
1Centro Nazionale di Epidemiologia, Sorveglianza e Promozione della Salute, Istituto Superiore di Sanità, Roma. nicola.vanacore@iss.it
Recenti Progressi in Medicina
|June 27, 2013
Summary
Italian registries tracked neurological drug use for Alzheimer's dementia and multiple sclerosis. These real-world data offer valuable insights into drug effectiveness and safety beyond clinical trials.
Area of Science:
- Neurology
- Pharmacovigilance
- Real-world evidence
Context:
- Two Italian registries examined neurological drug utilization: cholinesterase inhibitors for Alzheimer's dementia and natalizumab for multiple sclerosis.
- The Alzheimer's registry yielded an observational study, while the multiple sclerosis registry represents a unique, underutilized public health opportunity.
Purpose:
- To present two Italian experiences with drug registries for neurological conditions.
- To highlight the potential of registries in generating scientific evidence on drug risk/benefit profiles in real-world settings.
Summary:
- The cholinesterase inhibitor registry for Alzheimer's dementia resulted in an observational study.
- The ongoing natalizumab registry for multiple sclerosis, though rare internationally, offers significant public health potential, especially as natalizumab is used in patients outside initial registration studies.
Impact:
- Registries, when designed as observational studies, can supplement registration trials by providing crucial real-world data.
- These real-world data enhance understanding of drug safety and efficacy in diverse patient populations, informing clinical practice and public health strategies.
Related Concept Videos
01:25Drug Regulation
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
01:16Therapeutic Drug Monitoring: Overview and Classification
Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood at designated intervals to ensure the drug concentration stays within a therapeutic range. This monitoring is crucial for optimizing individual dosage regimens, enhancing therapeutic efficacy, and minimizing drug-related toxicity. TDM is vital for drugs with narrow therapeutic windows, significant variability in pharmacokinetics, and a clear correlation between plasma levels and...
01:16Clinical 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...
There are four phases in a clinical trial. A phase one...
01:29Clinically Relevant Drug Product Specifications: Methods of Establishment
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
01:26Drug 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...
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...
01:02Prescription, Nonprescription and Orphan Drugs
Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...