Books and Book Chapters

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  CMC and GxP

  Marvee Espiritu, Capt. Tej Ian Mehta, and Purushottam K. Dixit

  Publication Date: 2023

  This chapter focuses on chemistry, manufacturing, and controls (CMC) and Good “x” Practices (GxP) of investigational new drug applications. Pharmaceutical drug development necessitates a review of relevant CMC details. Review of the CMC details ensures identity, quality, safety, and stability of drug products before commercialization. Examples of CMC applications are provided in the context of drugs used in interventional radiology. Common challenges with CMC applications include insufficient information regarding safety and purity of pharmaceuticals and inconsistent pharmaceutical production practices. GxP provides regulations to ensure the safety of drug products throughout their manufacturing, storage, and distribution.

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  Funding Approaches

  Pranav Moudgil and Jatin Sharma

  Publication Date: 2023

  Research funding is the proverbial oil that lubricates the cogs of scientific innovation, and acquiring funding for interventional radiology studies is no different than for other academic disciplines. In this chapter, we discuss funding sources and how they present applicants with unique advantages and disadvantages, what makes for a good grant application and what makes for a poor grant application, and how you can position yourself to be in the former rather than the latter. Ultimately, most research will not just require an abundance of time, effort, and dedication but also the capital to invest in raw materials, devices, hardware, and software, and other design components to take an idea from the bench to the bedside.

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  Nonrandomized Controlled Trials

  Han G. Ngo, Chaitu Dandu, Girish B. Nair, and Sayf Al-Katib

  Publication Date: 2023

  Experimental studies can be divided into two broad categories: true experimental and quasi-experimental studies. An archetypical example of a true experimental study design is randomized controlled trials (RCTs), where participants are assigned to one of the comparison groups (e.g., either control or treatment group) randomly. Randomization yields comparison groups with minimal selection bias, enhancing the ability to assess the causal relationship between the intervention and the outcome. Although considered the gold standard for clinical research, RCTs are not always possible due to logistic and ethical concerns. Hence, nonrandomized controlled trials (NCTs)—a quasi-experimental study design that does not utilize random assignment—can be good alternatives when RCTs are not feasible. It should be noted that NCTs can also fall under prospective studies in addition to experimental studies. This chapter will focus on NCTs including basic principles, strengths and weaknesses, and applicability in interventional radiology research.

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  Chapter 92 - Adrenal gland imaging

  David S. Lin, Ka Kit Wong, Elaine M. Caoili, James Shields, Anca M. Avram, and Benjamin L. Viglianti

  Publication Date: 12-27-2022

  A variety of different pathologies can affect the adrenal glands. Highresolution anatomic imaging with computed tomography (CT) and magnetic resonance imaging (MRI) can demonstrate subtle irregularities of the adrenal contours and can identify lesions millimeters in size. When combined with sensitive biochemical tests of adrenocortical and medullary hormones, diagnosis of adrenal gland dysfunction can be made at very early stages of disease. Certain adrenal pathologies can be confidently diagnosed based on imaging features alone and can potentially circumvent the need for percutaneous tissue sampling. Additionally, functional imaging with nuclear medicine scintigraphy and positron emission tomography (PET) add significant clinical utility, particularly in the evaluation of biochemically functional tumors as well as distant extra-adrenal metastatic disease.

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  Image-guided percutaneous spine biopsy

  Richard Silbergleit

  Publication Date: 2-16-2017

  This textbook covers key areas and reviews important principles and steps in the preparation for and the performance of spine biopsy. Image-guided percutaneous biopsy techniques and their application throughout the spinal axis are presented and discussed in detail. The advantages and disadvantages of various spine biopsy instruments are reviewed. Commonly encountered biopsy scenarios are considered in order to help readers effectively manage these situations when they occur in their practices. Clear guidance is offered on patient selection and preparation, which are critical to safe and effective outcomes, and much emphasis is placed on procedural safety, with a focus on complication avoidance and the appropriate reporting of complications. Image-Guided Percutaneous Spine Biopsy will be a welcome one-stop shop providing up-to-date information for all physicians with an interest in the subject, including radiologists, surgeons, and pathologists.