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The US regulation of off-label uses of medicines
Published in Andrea Parziale, The Law of Off-label Uses of Medicines, 2023
In particular, the FDA requires pharmaceutical manufacturers to: Warn of contraindications, that is, situations in which the risk associated to the product use clearly outweighs any possible benefit.53Revise the product label as soon as there is “reasonable evidence of an association” between product use and a serious hazard.54 “Reasonable evidence of an association” means that label revision does not require that a causal link between product use and hazard is formally established.55Obtain prior FDA approval for any change in product labels to add or strengthen a warning.56
Statistical Methods for Assessment of Complex Generic Drugs
Published in Wei Zhang, Fangrong Yan, Feng Chen, Shein-Chung Chow, Advanced Statistics in Regulatory Critical Clinical Initiatives, 2022
Generic drugs are drug products that contain the same Active Pharmaceutical Drug Ingredient (API) as an already marketed brand-name drug. A generic drug should be identical with its brand-name version in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. In many countries, generic drugs are approved through an Abbreviated New Drug Application (ANDA). In other words, generic drug applications are generally not required to demonstrate safety and effectiveness of the generic product through animal and clinical studies like innovative drugs. Instead, a generic drug application should demonstrate that the generic drug would follow a similar behavior in human body as its brand-name counterparts. Bioequivalence (BE) is a primary evidence for the approval of generic drugs. In the US Food and Drug Administration (FDA) guidance, BE is defined as “the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study” (US FDA, 2020a).
Introduction
Published in Peri J. Ballantyne, Kath Ryan, Living Pharmaceutical Lives, 2021
Increasingly, pharmaceuticals are available as the solutions to human health problems, health risks, and to the challenges of everyday life. This is reflected in the growth in expenditures for pharmaceuticals in Organization for Economic Cooperation and Development (OECD) countries, as has been observed over several decades (Sarnak, Squires & Kuzmak, 2017). Country-specific data illustrate this trend. For example, in England, it is estimated that NHS spending on medicines grew from £13bn in 2010–2011 to £17.4bn in 2016–2017, a growth rate of about 5% per year (Ewbank, Omojomolo, Sullivan & McKenna, 2018). In Canada, in 2018, total drug spending was estimated to account for almost 16% of all health expenditures, at about $1,074 CDN per capita (Canadian Institute for Health Information, 2018). The Canadian Institute of Health Information reported that prescribed drug spending grew steadily, at an average rate of 10.6% per year from 1985 and 2005, and 7.6% between 2005 and 2010. Expenditures in 2017 were 5.5% higher than 2016 (Canadian Institute for Health Information, 2017, p. 7). In the United States – having the highest per capita spending on prescription drugs relative to other OECD countries (Sarnak, Squires & Kuzmak, 2017) – an IMS Health report that total spending on medicines in that country was $310bn USD in 2015, up 8.5% from the previous year (IMS Health, 2016), contextualises the current prominence of pharmaceuticals in health care and in people’s lives.
Discovering hidden patterns among medicines prescribed to patients using Association Rule Mining Technique
Published in International Journal of Healthcare Management, 2023
We collected data for our study from the hospital information system (HIS) of a multispecialty hospital in India. The HIS has a comprehensive relational database that provides complete records of patients and pharmaceutical items. Specifically, it has time-stamped entries of patients’ arrival, transfer and discharge, patient name, patient identification number, physicians’ details, provisional and final diagnoses, and dispensed pharmaceutical item details. We extracted the pharmaceutical item details of all patients admitted to the hospital during one financial year in the format shown in Table A1. There are 745,176 records collected in this format from the hospital pharmacy. The records include the patient identification number, pharmaceutical item issue date, issue number, pharmaceutical item order identification number, item code, item name and the quantity of the dispensed pharmaceutical item. Pharmaceutical items include medicines, syringes, bandages, and other medical supplies.
Biological treatment for erythrodermic psoriasis
Published in Expert Opinion on Biological Therapy, 2022
Biosimilars are biological medical products that demonstrate similarity to the original molecule (‘innovator’) in terms of pharmaceutical quality, mode of action, safety, and efficacy based on comprehensive clinical and non-clinical study data. They improve patient access to biologics by substantial reduction of cost. Intended copies refers to biological products that do not meet the stringent criteria for biosimilars and have not been compared adequately with the original molecule analytically or clinically. Several approved anti-TNF-α biosimilars are now available in the market and even more biosimilars are currently undergoing clinical trials. Evidence supporting interchangeability of biologics are, however, still lacking. Although biologics have demonstrated high efficacy and safety in psoriasis patients, cost of therapy remains a limiting factor in their utilization. Favorable pharmacoeconomics of biosimilars is expected to encourage clinicians to use biologics earlier in the treatment ladder in EP patients.
3D printing technology in healthcare: applications, regulatory understanding, IP repository and clinical trial status
Published in Journal of Drug Targeting, 2022
Dipak Kumar Gupta, Mohd Humair Ali, Asad Ali, Pooja Jain, Md. Khalid Anwer, Zeenat Iqbal, Mohd. Aamir Mirza
Drug/pharmaceutical products refer to the finished formulation e.g. tablets, capsules, etc containing the active ingredient and excipients [7]. Conventional drug products like tablets/capsules etc. as not too complex and have a defined shelf life (generally 2yrs). In general, pharmaceutical industries are supposed to be conservative, which avoids deviation from established manufacturing processes and product designs. 3DP breaks these limitations by creating complex and personalised products for rapid consumption [8]. In the era when we are getting exposed to cloud-based computing and contactless payments, the pharmaceutical industries cannot maintain a distance with 3DP for a longer period of time. Technology is now integrating with the pharmaceutical space at a significant pace. Research interests in 3D- printed drug products are also growing immensely which influence the overall drug product development. The major advantage of the technology is that you can get the desired batch size of the product (even for one patient) with tailored dosages, shapes, sizes and release characteristics. Poly-pharmacy (for geriatrics) is the scenario where patients tend to use multiple pills for different health-related conditions. 3D-printed pills can be a single shot solution where they combine different APIs into one formulation. Other than personalised care, it can also deal with emergency situations (disaster areas, military operations, and others) in a much-synchronized way with the demand.