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Preclinical Toxicology/Safety Considerations in the Development of Ophthalmic Drugs and Devices
Published in David W. Hobson, Dermal and Ocular Toxicology, 2020
Robert B. Hackett, Michael E. Stern
Intermediate-use drugs are typically those drugs employed in external eye disease and are represented by the anti-inflammatories and antimicrobials. These drugs are generally administered up to several times per day for treatment periods of 2 weeks to 3 months. A typical drug safety profile may include the following tests: Evaluation for mutagenic/genotoxicity potential to include in vitro and in vivo assaysAcute topical ocular irritation evaluation — rabbit1-month ocular/systemic toxicity evaluation — rabbit3- to 6-month ocular/systemic toxicity evaluation — rabbit and/or dog/monkey, if warrantedAppropriate systemic toxicity evaluations following parenteral administration, if warranted
Drug Safety Evaluation and Implications for Clinical Investigation
Published in Gary M. Matoren, The Clinical Research Process in the Pharmaceutical Industry, 2020
Drug safety evaluation or safety assessment or pathology and toxicology studies, as they are variously known, play an important role in every phase of drug development from the preclinical identification of early biological activity of possible therapeutic interest to postmarketing activities. Acute and subacute (subchronic) studies usually precede Phase I clinical trials. Chronic studies and special studies for carcinogenicity, mutagenicity, and reproductive studies usually precede New Drug Application (NDA) filing. Special studies on drug interaction, drug disposition, and overdose are often done before marketing. Postmarketing studies are done on the original dosage form following adverse reactions reported to the U.S. Food and Drug Administration (FDA), the pharmaceutical company, or international regulatory agencies. Experiments are sometimes conducted in response to questions from pharmacists, nurses, doctors, or patients. Examples of such experiments include: eye and skin studies relating to accidental contact of the drug to these tissues; compatibility studies of the drug with standard intravenous solutions; compatability studies with newly marketed agents to be given in conjunction with the drug in question; and, occasionally, studies in support of legal proceedings against the doctor, hospital, or drug firm relating to real or alleged adverse effects of the drug. Until a drug is withdrawn from all clinical use for economic, medical, or regulatory reasons, it cannot be forgotten by toxieologists and pathologists.
Pharmaceutical and Medical Device Product Liability Litigation
Published in Julie Dickinson, Anne Meyer, Karen J. Huff, Deborah A. Wipf, Elizabeth K. Zorn, Kathy G. Ferrell, Lisa Mancuso, Marjorie Berg Pugatch, Joanne Walker, Karen Wilkinson, Legal Nurse Consulting Principles and Practices, 2019
Vicki W. Garnett, Stacy Newsome
Prior to a drug entering the market, extensive testing must be performed to ensure drug safety and efficacy meet FDA standards. While this process does not eliminate the occurrence of adverse events, it is intended to reduce the incidence of drug reactions and identify potential side effects included in the drug label, so the consumer can make an informed risk versus benefit analysis with their healthcare provider prior to ingesting a drug.
Drug tolerability versus drug safety
Published in Journal of Dermatological Treatment, 2023
Stuti Prajapati, Rachel Tao, Steven R. Feldman
The FDA defines drug safety as the medical risk to the subject, analyzed by laboratory tests, vital signs, clinical adverse events, and other special safety tests in clinical trials (1). Drug safety is determined by objective criteria such as drug pharmacokinetics and metabolism, which may cause adverse effects in susceptible patient populations and in interaction with other drugs. Drug safety is a multifaceted concept based on factors such as patient age, health, and use of other medications. Vulnerable populations such as the elderly, children and pregnant women are at greater safety risks than the general population. Geriatric patients often have several chronic conditions requiring multiple medications, which increases the potential for harmful drug-drug interactions. Depending on the age of the pediatric patients, many of their organs have not fully developed resulting in varying metabolisms, which may increase toxic levels of a drug. In pregnant females, medication use can deleteriously affect the growing fetus.
An overview of methodological flaws of real-world studies investigating drug safety in the post-marketing setting
Published in Expert Opinion on Drug Safety, 2023
Salvatore Crisafulli, Zakir Khan, Yusuf Karatas, Marco Tuccori, Gianluca Trifirò
The evaluation of the post-marketing safety profile of drugs is a continuous monitoring process for approved and marketed medicines and it is crucial for detecting both common and uncommon adverse drug reactions (ADRs) as well as those that only manifest after prolonged drug exposure [13,14]. Real-world studies are particularly useful to supplement additional evidence from RCTs by providing evidence from larger and more heterogeneous populations, encompassing patients who are generally excluded from RCTs because of perceived vulnerabilities (e.g. children and adolescents, the elderly, pregnant or breastfeeding women), over larger observation periods [15]. The fact that one-third of newly identified safety issues in the post-marketing period are added to the label’s warnings and precautions section emphasizes the importance of post-marketing drug monitoring [16]. It has also been reported that, thanks to post-marketing drug safety studies, nearly 20% of new medications received a black box warning after marketing, and 4% were withdrawn from the market due to safety concerns [17]. Moreover, during the COVID-19 pandemic, multiple emergency use authorizations were granted to drugs, highlighting a situation in which post-marketing drug safety-based studies become critical to grant long-term patient safety [14].
Iron Supplementation Effectively Ameliorates Anemia and Reduces the Need for Blood Transfusion in Patients Undergoing Colorectal Cancer Surgery: A Meta-Analysis
Published in Nutrition and Cancer, 2022
Gang Tang, Linyu Zhang, Wang Huang, Zhengqiang Wei
Drug safety is an important issue that clinicians often pay attention to. The major adverse effects of taking iron orally are gastrointestinal disorders, including nausea, diarrhea, constipation, and abdominal distension (35, 36). There have also been studies showing similar gastrointestinal symptoms in patients treated with placebo, so iron-related gastrointestinal symptoms may be related to the capsule itself or the use of postoperative analgesics (37). In addition, there have been reports of low oral iron compliance, which may affect efficacy (27). The study we included did not evaluate adverse effects of oral iron. Therefore, future studies are needed to investigate the adverse effects and compliance of oral iron in CRC patients. Hypotension, anaphylaxis, infection, hypophosphatemia, and oxidative stress are common adverse reactions to intravenous iron (38). However, a large body of evidence suggests that intravenous iron supplementation appears to be safe. A systematic review of 103 randomized controlled trials including 10390 conducted in 2015 showed that intravenous iron did not increase the incidence of severe adverse events in the respiratory, cardiovascular, and nervous systems (39). A recent meta-analysis suggests that intravenous iron supplementation does not increase the risk of infection or death (40). Similarly, no adverse reactions with intravenous iron were observed in the two studies (20, 25) we included. Therefore, intravenous iron supplementation is an attractive and safe option