The purpose of this investigation was to evaluate the immunologic responses with these 3 serial doses of cat hair and dander extract at baseline, after reaching the maintenance dose (approximately 5 weeks), and after 1 year of maintenance immunotherapy. In 22 patients with cat asthma who were highly sensitive to cat, we compared, double-blind, the effects of immunotherapy with cat-hair and dander extract (11 patients) with effects of placebo (11 patients). Systemic reactions to cat-extract immunotherapy were mild and infrequent. This challenge becomes even greater for evaluations of more complex, multiextract mixtures that are used in clinical practice. 46 It also does not address the potential long Significant differences and similarities exist in SIT practice patterns of US and European allergy specialists. Grass pollen immunotherapy significantly reduces hay fever symptoms and medication requirements. Practical issues dealing with the administration of allergen immunotherapy (AIT) by European and US allergists are not well known. Allergen specific immunotherapy remains the only means to change the natural history of allergic disease. Still, comparison of allergen product potency, either based on total allergenic activity or individual allergen molecule content, is not possible due to a lack of standard reference preparations in conjunction with validated standard methods. Dose ranges for non-standardized products have also been modified over time. Preparation and standardization of allergen extracts Allergy: Principles and practice, Immunologic response to administration of standardized dog allergen extract at differing doses, Nasal challenge with ragweed pollen in hay fever patients: effect of immunotherapy, Allergic diseases are common, disabling and potentially life threatening. In the collaborative study, no deciding differences were observed between the two candidate ELISAs. Epstein T, Liss G, Berendts K, Bernstein D. AAAAI/ACAAI Subcutaneous Immunotherapy Surveillance Study (2013-2017): Fatalities, Infections, Delayed Reactions, and Use of Epinephrine Autoinjectors. Studies have shown that certain allergenic extracts contain enzymes that can cause a decrease in grass pollen allergenicity when mixed with grass extracts. Pertinent stability issues include the type of diluent used for extraction and mixing. For several cross-taxonomic (fungal-insect) extract combinations at 10 to 25% glycerin concentrations, different immunochemical test methods measuring single (major) or multiple allergens yielded threefold to 10-fold variations in allergen recoveries. In AAAAI Practice Management Resource Guide, 2012 ed American Academy of Allergy, Asthma and Immunology, 1–39, 2012 95115 Professional services for allergen immunotherapy not including provision of allergenic extracts; single injection 95117 2 or more injections Note that 95117 is not an add-on code: Do not report 95115 with 95117; one or the other is coded, not both. The guidelines, rules, and regulations for these activities have been established and continue to be developed as progress is made. We analyzed data on the allergen sources European HDM, American HDM and cat epithelium, which were collected by the Society for Promoting Quality Assurance in Medical Laboratories (INSTAND e.V.) 90.4% (20/21) felt labels containing all recommended practice parameter guidelines, components would decrease error; and standardization of labels, buildup and missed dose schedules would increase workflow efficiency (76%; 16/21). To determine whether specific immunotherapy alters mediator release in vivo, nasal pollen challenge was used to compare 27 untreated highly sensitive ragweed (RW)-allergic subjects with 12 similarly sensitive patients receiving long-term immunotherapy (3-5 yr) with RW extract (median dose, 6 micrograms RW antigen E). Coefficients of variation (CV) were determined in order to evaluate interlaboratory comparability. 1150 0 obj <>/Filter/FlateDecode/ID[<3204519B1FB46D44A3C9673FA9F8C395>]/Index[1142 13]/Info 1141 0 R/Length 56/Prev 117405/Root 1143 0 R/Size 1155/Type/XRef/W[1 2 1]>>stream Over the past 12 years, there have been three sets of published AIT guidelines, 1-4 the most recent being the third AIT practice parameter (PP) update published in 2011 by the American Academy of Allergy, Asthma & Immunology (AAAAI), the American College of Allergy, Asthma and Immunology, and the Joint Council on Allergy, Asthma and Immunology. Several genes, including ADAM33, DPP10, PHF11, GPRA, and TIM-1, have been implicated in the pathogenesis and susceptibility to atopy and asthma. Fescue and dust mite allergen recoveries varied considerably when mixed with different mold extracts. Results: Reasons for nonadherence included having personalized labeling systems (55.4%, 174/314), unfamiliarity (14%, 44/314) and disagreement (9%, 29/314) with practice parameter guidelines. The development of validated stability-indicating tests and their clinical verification remains a fundamental challenge for extending this information to cover more products. Injected glycerin produces pain that is proportional to total injected dose of glycerin, but individual variation in perceived discomfort is substantial. We sought to assess the efficacy and safety of specific immunotherapy with 2 doses of Alutard grass pollen in patients with moderately severe seasonal allergic rhinitis inadequately controlled with standard drug therapy. These extracts have helped make allergen immunotherapy a proven, clinically effective treatment for patients with allergic rhinitis, allergic asthma and hypersensitivity to insect stings. PubMed, homepages relevant to the topic, and the National Institutes of Health clinical trial database were searched. This ensures, at least with standardized allergen vaccines, comparability between lots used in clinical practice. This paper reviews the pertinent studies used to guide practising allergists on allergen extract compatibility and stability. Main reasons for continuing beyond 5 years were "after stopping, symptoms reappeared" or "patient afraid to relapse." @BULLET@BULLET Cox L, Nelson H, Lockey R, et al. Furthermore, sleep-disordered breathing in childhood and adolescence is associated with increased disorders of learning performance, behavior, and attention. The patients were given the following maintenance doses: 19 patients 10,000 standardized quality units (SQ-U) (group 10, 0.7 microgram Der p I), 20 patients 100,000 SQ-U (group 100, 7 micrograms Der p I), 16 patients 300,000 SQ-U (group 300, 21 micrograms Der p I), and 19 control patients (group 0) had no injections. The concentration of 10,000 BAU/mL of Bermuda grass, 1 : 20 w/v or 10,000 PNU/mL of Johnson grass and 1 : 40 w/v or 10,000 PNU/mL of careless weed yielded the most positive SPT results. Studies included skin prick tests and late cutaneous reactions with cat hair and dander extract, titrated nasal challenges with the extract, serum cat allergen-specific IgG4 and IgE measurement, and flow cytometric and ELISA analysis of whole blood and intranasal cytokines (TGF-beta, IL-10, IFN-gamma, IL-4, and IL-5). Proteomic methods including mass spectrometry allow as well to investigate protein-protein interactions, thus yielding precise information on critical epitopes on the surface of allergens. Effect of immunotherapy, Immunotherapy decreases skin sensitivity to cat extract, Responses to ragweed-pollen nasal challenge before and after immunotherapy, Effect of mixing allergenic extracts containing Helminthosporium, D. farinae, and cockroach with perennial ryegrass, A controlled dose-response study of immunotherapy with standardized, partially purified extract of house dust mite: Clinical efficacy and side effects, Pain and dermal reaction caused by injected glycerin in immunotherapy solutions, A 1-year, placebo-controlled, double-blind house-dust-mite immunotherapy study in asthmatic adults, Grass pollen immunotherapy for seasonal rhinitis and asthma: A randomized, controlled trial, Cross-Reactivity of Plant and Animal Allergens, Regulatory Aspects of Allergen Vaccines in the US, Manufacturing and standardizing fungal allergen products, Dose dependence and time course of the immunologic response to administration of standardized cat allergen extract, Efficacy and safety of specific immunotherapy with SQ allergen extract in treatment-resistant seasonal allergic rhinoconjunctivitis, Immunological Response to Administration of Standardized Dog Allergen Extract at Differing Doses, The potential impact of USP 797 and what the JCAAI is doing about it, Stability of standardized grass, dust mite, cat, and short ragweed allergens after mixing with mold or cockroach extracts, Stability of allergen extracts used in skin testing and immunotherapy, Guidelines for using pollen cross-reactivity in formulating allergen immunotherapy, An Update of Immunotherapy for Specific Allergies. To review the current knowledge regarding recombinant and purified allergens and allergen-derived peptides. In parallel, two sandwich ELISA systems for quantification of Bet v 1 were found suitable in preliminary phases of BSP090 to be validated in a large collaborative study. The assessment was completed with a comparative quantification of Bet v 1 in 30 marketed birch allergen products in one laboratory, simulating the future use as reference method. This discrepancy emphasizes the usefulness of MD, at least in areas of complex sensitization to pollen, in determining correct indication of SIT. Mixtures were prepared using individual products from multiple sources at variable glycerin concentrations and were analyzed after storage for up to 1 year at 2 degrees C to 8 degrees C. Quantitative analyses included radial immunodiffusion assays for cat Fel d 1 and short ragweed Amb a 1 and human IgE enzyme-linked immunosorbent assay inhibitions for meadow fescue grass and dust mite allergens. Testing: Medically Necessary . Immunotherapies for asthma and allergies aim to suppress or modify detrimental immune responses that contribute to allergic disease pathogenesis. Efficacy and safety of specific immunotherapy with SQ allergen extract in treatment-resistant seasonal allergic rhinoconjunctivitis. Model samples containing recombinant rBet v 1.0101 as well as native birch pollen extracts were measured independently at least three times in each facility. After 24 months bronchial challenge demonstrated a dose-related increased tolerance to Der p I, group 10 (p = 0.003), group 100 (p = 0.0005), group 300 (p = 0.0007), with no change in group 0 (p = 0.6). Background: Little is known about the adherence rate to allergen immunotherapy (AIT) labeling guidelines. SLIT involves regular self-administration at a certain time of the day; with retention of Patients were randomly assigned to one of two treatment groups. In this regard, since many patients are poly-allergic, mixtures of allergen extracts are often used with a potential risk to cause allergen degradation, thereby affecting treatment efficacy. Eleven adult patients started immunotherapy after a season of symptom diaries and graded pretreatment challenges with 0.03, 0.3, 3.3, and 16.5 mg of ragweed pollen. SLIT dose finding studies should be done for each product. Impairment of overall quality of life (mean score of 7 domains) during the pollen season was less in the immunotherapy group than in the placebo group (median difference [95% CI], 0.8 [0.18-1.5]; P =.02). Local and delayed side effects were common but generally mild. Although formerly regarded as a nuisance disease, allergic rhinitis (AR) has a considerable effect on quality of life and can have significant consequences if left untreated. To determine the stabilities of standardized grass, short ragweed, dust mite, and cat extracts after mixing with fungal and cockroach extracts at final product concentrations similar to those recommended for maintenance immunotherapy injections. Nasal congestion, the most prominent symptom in AR, is associated with sleep-disordered breathing, a condition that can have a profound effect on mental health, including increased psychiatric disorders, depression, anxiety, and alcohol abuse. mechanism for the control of allergic airway inflammation in response to inhaled antigens. In the 1990s, the Japanese Society of Allergology (JSA) standardized Japanese cedar pollen allergen vaccines. For allergen immunotherapy trained Compounding personnel including, but not limited to, registered nurses, medical assistants, or physicians’ assistants, be employed which strictly follow allergen extract preparation guidelines. Allergen extracts for immunotherapy: To mix or not to mix? Lockey R, Ledford, D. Allergen Immunotherapy in a Historical Perspective. The importance of fungal allergen products in the practice of clinical allergy is frequently underestimated. Concerning allergens used in the most common prescriptions before and after MD results, we obtained the following results: κ = 0.117 ± 0.0825 for grass; κ = 0.1624 ± 0.0639 for olive; κ = 0.0505 ± 0.0548 for olive and grass; κ = 0.1711 ± 0.0471 for grass and cypress; κ = 0.1897 ± 0.0493 for grass and London plane; κ = 1 ± 0.0842 for olive and cypress, and κ = 0.3586 ± 0.0798 for other combinations. Ironically, health care providers overestimate patient satisfaction with therapy. You can request the full-text of this article directly from the authors on ResearchGate. The establishment of additional allergen reference standards and the development of reliable, accurate, and clinically relevant potency assays are urgently needed. Allergenic vaccines are pharmaceutical preparations derived from the natural sources which contain the allergenic components responsible for allergic sensitization. The United States Pharmacopeia (USP) has proposed changes to be required of all sterile compounding, including allergen extract preparation. Methods: To describe the prescribing patterns for cat AIT among practicing allergists in a large health care system and the effect of practice parameters on these patterns. Results: The presence of cockroach extracts reduced dust mite allergen potencies but retained moderate levels of cat and short ragweed allergen activities. There was very low agreement concerning indication and use of allergens for SIT before and after performing MD. Herein, we discuss the advantages and drawbacks of mixing homologous (i.e., related) or heterogeneous (i.e., unrelated) allergen extracts. Outcome measures included hay fever symptoms and medication use, health-related quality of life, and measurements of nonspecific bronchial responsiveness. Objective: Further studies should help clarify outstanding issues about appropriate patient selection, efficacy using various allergens and extracts, and optimal administration protocols. A dose-response relation was demonstrated, with rates of systemic reactions in percent of injections; group 10, 0.56%; group 100, 3.30%; and group 300, 7.10% (p < 0.0001). Many patients receive less than recommended doses. In the USA, the standardization of the extracts also focuses on the allergenic potency, however the FDA mandates the use of reference extracts to standardize several allergen sources [19], Call for candidates-USP expert panel on general chapter <797> pharmaceutical compounding-sterile preparations. Although the AIPP does not specifically recommend a specific diluent, recent evidence suggests normal saline may not be as effective a stabilizer for extract dilutions as glycerin or human serum albumin. Background: The immunized group had a diminished response as demonstrated by (a) the treated group required higher pollen doses to excite sneezing or mediator release; (b) significantly fewer subjects in the treated group released mediators at any dose (TAME-esterase [P = 0.005], PGD2 [P = 0.04]), and (c) the treated group released 3-5-fold less mediator (TAME-esterase [P = 0.01], and histamine [P = 0.02]). Grass pollen immunotherapy improves quality of life in seasonal allergic rhinitis and reduces seasonal asthma symptoms and bronchial hyperresponsiveness. Many of the most rigorous studies on allergen stability have been performed by allergenic extract manufacturers in support of Food and Drug Administration approved dating for standardized products and are not published. Objectives: Results: Twenty-three patients completed the study. Allergen standardization in the United States is based on the establishment of a national reference assigned with a biological potency unit to which manufacturers' products are compared using validated relative potency assays. Conclusions: From January 2003 to September 2007, 1,810 prescriptions (18.0%) were written in the recommended range. Note to ACAAI members and non Coverage: Benefits may vary between groups/contracts. The possibility of prophylactic vaccination based on recombinant fusion proteins consisting of viral carrier proteins and allergen-derived peptides without allergenic activity are also discussed. Injection site erythema, induration, and bruising occurred in some subjects with significant positive correlations between total glycerin dose and both frequency and diameters of erythema and induration. Major emphasis on immunotherapy for asthma during the past decade has been to direct The quiz contains 30 questions on the preparation of allergenic extract. All tests showed significant decreases in ryegrass potency when mixed with Helminthosporium and cockroach. The 100,000-SQ-U regimen was more effective, but the 10,000-SQ-U regimen caused fewer side effects. At the same time, qualitative differences exist between manufacturers' products, and most allergen vaccines used in clinical practice are nonstandardized. Significant reductions were observed in the immunotherapy group compared with the placebo group in hay fever symptoms (49%, 15%; P =.01), medication scores (80%, 18%; P =.007), and seasonal chest symptoms (90%, 11%; P <.05). In total, 2104 injections were given, and 3.5% were followed by a systemic reaction, defined as a fall 15% or greater in forced expiratory volume in 1 second within 30 minutes. Immunotherapy doses were increased to a maintenance dose of 4.56 Food and Drug Administration (FDA) units of Fel d I or if maintenance dose was less, to the highest tolerated dose. Measurements of relative potency and major allergen content correlated well. The Allergenic Extract Quiz was developed to demonstrate that those preparing extract are doing so in a sterile manner and are following the 2019 USP Chapter 797 guidelines. The efficacy of allergen immunotherapy has been known since 1911, when Noon injected an extract of grass pollen into a person in England whose allergic … Recent progress in the ability to measure the specific allergen content of allergen vaccines has led to its application in monitoring consistency and characterizing allergen preparations. The regulatory framework in the EU has induced great advancements in the field in the last years although national implementation still remains heterogeneous. Proposed standards for allergen extract compounding under USP Chapter 797 Under the proposed standards, to continue in-office compounding of individual treatment sets for allergen immunotherapy, allergy practices will need to comply with the following: Allergy clinic personnel are required to follow the Allergen Immunotherapy Extract Preparation Guidelines as stated in the practice parameters developed by the American Academy of Allergy, Asthma, and Immunology (AAAAI Remission was achieved in 74.5% of the 47 patients in the study group and in 20% of those in the control group. To determine the stabilities and compatibilities of Alternaria alternata and German cockroach allergens in mixtures with other high-protease fungal and insect (cockroach, imported fire ant) extracts at final extract concentrations consistent with injection dose targets for maintenance immunotherapy. Across the whole pollen season, mean symptom and medication scores were 29% and 32% lower, respectively, in the 100,000-SQ-U group compared with those in the placebo group (both P < .001). It is a cellular test able to investigate basophil behavior during allergy and allergy immunotherapy. Even though allergies are an important health issue, the detected amount of allergen-specific IgE (sIgE) has differed widely between manufacturers in the past, and even as recently as this year. Peak-flow measurements at home showed no significant changes during the study. Journal of Allergy and Clinical Immunology, 2011. Analysis was performed using RAST inhibition, SDS-PAGE and, to determine biologic potency, a quantitative intradermal skin test technique. In the U.S., the preparation of diagnostic and therapeutic extracts requires the cooperation of the extract manufacturer, who provides the individual allergen concentrates, and the practicing physician who formulates, dilutes, and administers the final patient-specific treatment extract. They suffer a dramatic transformation during the manufacturing process which renders a biologically standardized final product. Pain scores of subjects given glycerin (0.1 to 1 ml, 10% to 30%) increased significantly as both injection volume (p less than 0.001) and glycerin concentration (p less than 0.001) increased. Relative potency was approximately 10 times higher for US concentrate standardized extracts-which are meant to be diluted-than for European SLIT maintenance solutions of D pteronyssinus and timothy grass pollen. Data sources: All rights reserved. The response to titrated nasal allergen challenge, titrated skin prick testing, and allergen-specific IgG4 measurement to cat immunotherapy at 5 weeks is predictive of the response at 1 year. Additional findings that are increasing our knowledge of extract shelf life will be discussed. Minor differences exist between these guidelines, but both focus on aseptic techniques and require that compounding personnel pass a written examination and annual media fill test. date, the use of AIT is becoming more acceptable in China, and there are many studies about the current clinical practice immunotherapy. Allergen extract immunotherapy preparation guidelines were developed independently, first by a Joint Task Force of the American Academy of Allergy, Asthma, and Immunology, American College of Allergy, Asthma, and Over the peak pollen season, mean symptom and medication scores were 32% and 41% lower, respectively, than those in the placebo group. Commercial interests currently favor producing standardized drug-grade allergen extracts for therapeutic use, and clinical trials are ongoing. Therefore, this approach can be confusing and is misleading. Use of these mixtures in immunotherapy vaccines is supported for practitioners seeking to optimize formulations, doses, and treatment regimens for their patients. Allergen immunotherapy involves the regular administration of gradually increasing doses of allergen extracts over a period of years. Conclusions: In the United States, AR results in 3.5 million lost workdays and 2 million lost schooldays annually. It is imperative that allergists comply with the highest recommended standards to provide the best clinical outcomes and ensure excellent and efficient care in both allergy and non-allergy offices. Both genetic and environmental factors affect the allergenic composition of pollen because it is a biologically active pharmaceutical ingredient obtained from nature. The original practice parameter published in December 1996 did not recommend a dose of cat allergen, but updates in January 2003 and September 2007 recommend cat extract dose ranges of 2,000 to 3,000 BAU and 1,000 to 4,000 BAU, respectively. Data sources: The greatest and most consistent response is seen with a dose containing 15 mug Can f 1. Glycerin and buffered saline with phenol (BSP) extracts containing Helminthosporium interseminatum, D. farinae, and cockroach were mixed with perennial ryegrass extracts and analyzed 7, 30, 60, and 90 days after mixing to determine the mixing effect of these extracts on the ryegrass pollen potency. Background: Validation of candidate European Pharmacopoeia standard methods for quantification of major birch allergen Bet v 1, Immunotherapy in allergy and cellular tests State of art, Evaluation of the manufacturer-dependent differences in sIgE results for indoor allergens, Comparison of the efficacy and safety of pollen allergen extracts using skin prick testing and serum specific IgE as references, Single recombinant and purified major allergens and peptides, Validation of ELISA methods for quantification of the major birch allergen Bet v 1 (BSP090), Immunotherapy in the Management of Asthma and Other Allergic Conditions, Standardization and Regulation of Allergen Products in the European Union. 1. In vitro total IgE binding potency was analyzed by the competitive ELISA using a pooled serum, with sera obtained from 10 allergic patients. After missing 1 to 3 doses, the dosing schedules were mostly followed (build-up phase: repeat last dose, reduce by 1 dose, reduce by 2doses; maintenance phase: reduce by 1 dose, reduce by 2 doses, reduce by 3 doses). Immunotherapy with a single allergen extract is effective in the first, 149 while immunotherapy has been shown to be ineffective 150 or less effective in the last situation. The standard should also be characterized with respect to content of main (major) allergenic proteins, protein profile, and protein structure. There were no significant changes in symptom scores; lymphocyte proliferation; secreted IFN-gamma, IL-10, or IL-5; or intracellular cytokine production. Fifty percent glycerin greatly extends the time over which extracts remain potent, including in mixes with fungal and insect extracts known to contain protein-degrading enzymes. Three online surveys were distributed: AIT Administrator and Manager surveys for healthcare personnel at the "Big 10"; University Health Services and Physician Survey for physician members of the AAAAI. This study demonstrated a dose dependence of efficacy and side effects of IT in asthmatic patients. Cluster immunotherapy was administered to 28 patients with dog allergy who were randomly assigned to 1 of 4 treatment arms: placebo or acetone-precipitated extract containing 0.6 mug, 3.0 mug, or 15.0 mug Can f 1 per 0.5 mL maintenance dose. The data were subdivided into periods before and after the 3 published AIT practice parameters. General information The active substance can be an allergen extract, as well as a purified natural or recombinant protein, all of which can be unmodified or modified (e.g. We studied Dermatophagoides pteronyssinus, timothy grass pollen, cat (hair) and short ragweed pollen allergen extracts. The potential effect of airborne contaminants in pollen requires major attention but can be properly addressed through careful collection practices, combined with a proper interpretation of the data on purity obtained for each pollen lot. 11 Due Before and during immunotherapy, we measured by intradermal titration the dose of cat extract, in FDA units of Fel d I equivalents, required for (1) 2+ end point (wheal diameter, greater than or equal to 10 mm; erythema diameter, 20 to 30 mm) and (2) 20 mm end point (erythema diameter, 20 mm). Patients struggle to alleviate their misery, frequently self-adjusting their treatment regimen of over-the-counter and prescription medications because of lack of efficacy, deterioration of efficacy, lack of 24-hour relief, and bothersome side effects. Conversion tables were created based on the fixed mathematical relationships between extract concentrate strengths and maintenance immunotherapy dose targets. Both systems detected substantial differences in Bet v 1 content between allergen products, but the effect was more pronounced using ELISA-B due to persistently higher values compared to ELISA-A. in sensitized persons. could also exacerbate asthma symptoms. To date, the potency of allergen products in Europe is expressed in manufacturer-specific units relative to a product-specific in-house reference. Despite this, there appears to be a cautious trend towards an alignment of the results and interlaboratory comparability with the exception of one supplier. The relative monthly allergen dose in (B)AU was calculated for each recommended SLIT schedule. Data collected looked at patient identifiers (PI), concentrations in volume/volume (v/v) format, color coding, allergen content, expiration date and instructions about AIT dosing, and systemic reaction treatment. After they had received 1 year of immunotherapy, patients receiving cat extract, in comparison to patients receiving placebo, had decreased cat-extract PD20 (p less than 0.01), diminished responses to cat-extract intradermal STEPT (p less than 0.025), increased IgE antibodies toward cat extract (p less than 0.01), increased IgG antibodies toward cat extract, Fel d I, and cat albumin (p less than 0.001), but no significant change in cat-extract in vitro LHR or in methacholine PD20. In the U.S., the preparation of diagnostic and therapeutic extracts requires the cooperation of the extract manufacturer, who provides the individual allergen concentrates, and the practicing physician who formulates, dilutes, and administers the final patient-specific treatment extract. In vivo allergenic potency was determined by intradermal testing of 51 Japanese adults with positive serum specific IgE to HDM allergens. Nonspecific immunotherapies target key mediators in allergic inflammation and therefore can be beneficial for all patients with allergic disease regardless of their allergen triggers.
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