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Vasculitides
Published in Ayşe Serap Karadağ, Lawrence Charles Parish, Jordan V. Wang, Roxburgh's Common Skin Diseases, 2022
Ivy M. Obonyo, Virginia A. Jones, Kayla A. Clark, Maria M. Tsoukas
Management: CPAN is chronic and may have a remitting and relapsing pattern. Therapeutic options are dependent on disease severity. Consider topical steroids, such as mometasone, when mild with erythema only. NSAIDs or colchicine may be used in mild cases that present with livedo reticularis and nodules. Oral prednisolone can be efficacious when severe. If CPAN is due to group A beta hemolytic streptococcal infection, then treat with penicillin.
Validation Strategy for Biomarker-Guided Precision/Personalized Medicine
Published in Wei Zhang, Fangrong Yan, Feng Chen, Shein-Chung Chow, Advanced Statistics in Regulatory Critical Clinical Initiatives, 2022
A CDx is officially defined as an In Vitro Diagnostic (IVD) device that provides information that is essential for the safe and effective use of a corresponding therapeutic product (FDA 2014). The FDA emphasizes four subareas for a CDx, and they are (i) identify patients who are most likely to benefit from the therapeutic product, (ii) identify patients likely to be at increased risk for serious adverse reactions as a result of treatment with the therapeutic product, (iii) monitor response to treatment with the therapeutic product for the purpose of adjusting treatment to achieve improved safety or effectiveness, and (iv) identify patients in the population for whom the therapeutic product has been adequately studied, and found to be safe and effective (FDA 2014). In the past few years, an increasing number of predictive biomarker assays have been developed to guide anticancer treatment (Harigopal et al. 2020, Hersom and Jorgensen 2018, Rothschild 2014, Shaw et al. 2014, Twomey and Zhang 2021). Prior to the entry of individuals into a clinical trial, CDx might identify a population that has a higher likelihood of response and safety. Recently, the CDx is often developed in parallel to the drug using the drug-diagnostic co-development model (Jorgensen and Hersom 2016, Mansfield 2014, Watanabe 2015) (Figure 3.1).
Therapeutic effectiveness
Published in Dinesh Kumar Jain, Homeopathy, 2022
Now we should know how much time will be taken by a drug for its development? And what types of studies are required before successful development of a drug or treatment? Initial safety, biological effects, receptor study, enzyme inhibition and selectivity, drug absorption, metabolism, excretion, therapeutic efficacy, dose range, kinetics and adverse reaction, acute, subacute, chronic studies, effect on reproductive behavior, carcinogenic potential, mutagenic potential are studied and analyzed by clinical pharmacologist and physicians. Most new drug candidates are identified through chemical modification of known molecules, screening of natural products or previously discovered chemical entities for biological activity or rational drug design based on an understanding of biological mechanisms. Average ten years are taken by a drug before marketing and even after marketing surveillance is continued. If new toxicity appears after marketing, the drug is withdrawn from the market and the whole exercise of drug development becomes useless.
Localized, on-demand, sustained drug delivery from biopolymer-based materials
Published in Expert Opinion on Drug Delivery, 2022
Junqi Wu, Sawnaz Shaidani, Sophia K. Theodossiou, Emily J. Hartzell, David L. Kaplan
The field of medicine depends on therapeutics to treat or cure diseases. In 2020, it was estimated that $1.3 trillion was spent globally on prescription drugs [1]. As more therapeutics are developed, there is an opportunity for refined modes of delivery to increase safety and efficacy. With any mode of drug delivery, the active pharmaceutical ingredient (API) should be delivered at a concentration that reaches the therapeutic index, which describes the dose range where a medication is effective without causing adverse effects [2]. This concentration can be challenging to achieve due to unpredictable drug release rates, the inability to precisely target the desired tissues, renal/hepatic clearance of the delivered drugs, and unreliable stability of the therapeutic [3]. As a result, when therapeutics are delivered systemically, they often must be delivered at much higher concentrations than the target requirements to achieve an effective dose (Figure 1), leading to adverse side effects or harm to other organs.
Sema4D correlates with tumour immune infiltration and is a prognostic biomarker in bladder cancer, renal clear cell carcinoma, melanoma and thymoma
Published in Autoimmunity, 2021
Qiongyu Lu, Ping Cai, Yan Yu, Ziting Liu, Guona Chen, Zhao Zeng
Our findings that higher Sema4D expression was linked to a favourable clinical outcome, seemed to be different from previous studies that Sema4D enhances tumour angiogenesis and progression [17]. In fact, the outcome of patients is affected by many factors such as therapeutic efficiency and sensitivity, compliance of patients, and so on. For example, BCR-ABL fusion gene is a driver factor in pathogenesis and progression of chronic myeloid leukaemia (CML), but the CML patients with BCR-ABL have a favourable outcome because of the application of tyrosine kinase inhibitors [44]. In addition, the different reference cohort could also partly account for this discrepancy. Nevertheless, most previous studies on the biological activity of Sema4D was commonly investigated by manipulation of Sema4D expression in cancer cell lines and mice, rather than in human patients [18].
Contextual assessment: evaluating a novel self-guided online therapeutic assessment
Published in International Journal of Psychiatry in Clinical Practice, 2021
Maxwell Levis, Albert J. Levis
The IOQ was created for the current study and consists of two five-item subscales that evaluate the participant’s experience completing the intervention. These subscales explore, respectively, to what extent participants felt that CA offered 1) diagnostic and 2) therapeutic benefits. Although there are several widely used satisfaction measures, the IOQ is unique as a therapeutic assessment satisfaction evaluation. The IOQ was administered upon completion of CA and at follow up. IOQ items use a 5-point Likert scale, ranging from ‘strongly disagree’ to ‘strongly agree’. To aid analytical simplicity (Alreck et al. 1995), the initial coding system was recoded to a three-point ‘disagree’ ‘neither agreed or disagree’ or ‘agree’ scale. A sample item from the diagnostic benefit factor is ‘I felt this program was diagnostic’. A sample item from the therapeutic benefit factor is ‘I felt this program motivated changes’. The IOQ’s full items are listed in Table 4.