• safety evaluation of the food enzyme phospholipase a1

    Safety evaluation of the food enzyme phospholipase A1

    The European Commission requests the European Food Safety Authority to carry out the safety assessment on the food enzyme: phospholipase A1 produced by a genetically modified Aspergillus niger (strain NZYM‐FP) in accordance with Article 29 of the Regulation (EC) No 178/20024 4 Regulation (EC) No 178/2002 of the European Parliament and of the Council of

  • safety evaluation of the food enzyme phospholipase c

    Safety evaluation of the food enzyme phospholipase C

    The European Commission requests the European Food Safety Authority to carry out the safety assessment of the following food enzyme: phospholipase C produced by a genetically modified strain of Bacillus licheniformis (strain NZYM‐VR) in accordance with Article 29 of Regulation (EC) No 178/20024 4 Regulation (EC) No 178/2002 of the European Parliament and of the Council

  • safety evaluation of the food enzyme α‐amylase from the

    Safety evaluation of the food enzyme α‐amylase from the

    The food enzyme α‐amylase (4‐a‐ d ‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Pseudomonas fluorescens strain BD 15754 by BASF Enzymes LLC 1. The food enzyme is free from viable cells of the production organism and recombinant DNA . The α‐amylase is intended to be used in distilled alcohol production and starch processing for the

  • safety evaluation of the food wiley online library

    Safety evaluation of the food Wiley Online Library

    Safety evaluation of the food enzyme 4‐phytase from a genetically modified Trichoderma reesei (strain DP ‐Nzt55),and you may need to create a new Wiley Online Library account. Request Username. Can't sign in? Forgot your username? Enter your email address below and we will send you your username. Email or Customer ID . Close. If the address matches an existing

  • evaluation of the safety wiley online library

    Evaluation of the Safety Wiley Online Library

    Evaluation of the Safety, Tolerability, Pharmacokinetics, and Food Effect of Danirixin Hydrobromide Tablets in Japanese Healthy Elderly Participants. Takayuki Iida . Corresponding Author. E-mail address: takayuki.2.iida@gsk. Clinical Pharmacology Office, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan. Corresponding Author : Takayuki

  • references the microbiological risk assessment of food

    References The Microbiological Risk Assessment of Food

    If you do not receive an email within 10 minutes, your email address may not be registered, and you may need to create a new Wiley Online Library account. Request Username Can't sign in?

  • criteria for the evaluation of functional foods

    Criteria for the Evaluation of Functional Foods

    Summary This chapter contains sections titled: Preamble Differentiation of Functional Foods From Other Foodstuffs and Products Evaluation of the Safety to

  • safety evaluation of excessive wiley online library

    Safety Evaluation of Excessive Wiley Online Library

    Safety Evaluation of Excessive Ingestion of Mozuku Fucoidan in Human. Sunao Abe. Corresponding Author. Marine Products Kimuraya Co., Ltd., 3307 Watari, Sakaiminato, Tottori 684‐0072, Japan . Direct inquiries to author abe (E‐mail: abe@mozuku1-ban.jp).Search for more papers by this author. Kimiko Hiramatsu. Dept. of Adult and Elderly Nursing, School of Health

  • toxicological evaluation of karnal bunt wheat

    TOXICOLOGICAL EVALUATION OF KARNAL BUNT WHEAT

    Toxicological evaluation of Karnal bunt wheat was carried out in monkeys, feeding a diet containing 70% karnal bunt wheat, for 12 weeks. Blood was drawn once every two weeks. In addition to hematological parameters, total protein, albumin, alkaline phosphatase and transaminases were estimated in serum. The results of the study did not indicate any adverse

  • evaluation of the safety of sodium‐glucose co‐transporter

    Evaluation of the safety of sodium‐glucose co‐transporter

    Aim. To conduct an overall safety assessment of sodium‐glucose co‐transporter‐2 (SGLT‐2) inhibitors used for the treatment of patients with type 1 diabetes (T1D), including ketoacidosis, genital infection, volume depletion, liver and kidney injury events, cardiovascular events, diarrhea and severe hypoglycaemia.

  • criteria for the evaluation of wiley online library

    Criteria for the Evaluation of Wiley Online Library

    Summary This chapter contains sections titled: Preamble Differentiation of Functional Foods From Other Foodstuffs and Products Evaluation of the Safety to Health Functionality and Claims Observatio...

  • log in to wiley online library

    Log in to Wiley Online Library

    Objective To evaluate the pharmacokinetics, safety, and tolerability of a single 50‐mg oral dose of diclofenac potassium for oral solution (OS) in a pediatric cohort with a diagnosis of episodic mi...

  • study on safety evaluation and wiley online library

    Study on safety evaluation and Wiley Online Library

    Safety analysis is used as a key component of design evaluation for examining potential hazards during startup. Potential hazards are eliminated by modifying both plant structure and operating procedures. Issues for both methodology and implementation of a prototype in G2 are discussed. Finally, the system is applied to an industrial hydrodesulfurization process.

  • evaluation of the safety of sodium‐glucose co‐transporter

    Evaluation of the safety of sodium‐glucose co‐transporter

    Aim. To conduct an overall safety assessment of sodium‐glucose co‐transporter‐2 (SGLT‐2) inhibitors used for the treatment of patients with type 1 diabetes (T1D), including ketoacidosis, genital infection, volume depletion, liver and kidney injury events, cardiovascular

  • quality assessment, functional potentials and safety

    Quality Assessment, Functional Potentials and Safety

    The aim of this study was to evaluate the quality, functional and safety characteristics of Egyptian honey, as sensitive environmental bioindicator, collected from nine different locations in Egypt that were exposed to various air pollution sources either stationary, mobile or area sources and stored for 6 months at ambient temperature (22 o C ±2), comparing with Codex Alimentrius

  • evaluation of the pharmacokinetic interaction of

    Evaluation of the Pharmacokinetic Interaction of

    Objective. To evaluate the potential for pharmacokinetic interaction and the safety and tolerability when ubrogepant and sumatriptan are coadministered in a Phase 1 study in healthy participants, and to inform the safety and tolerability of ubrogepant alone and in combination with triptans in Phase 3 trials in participants with migraine.

  • safety evaluation of chemicals: the regulatory framework

    Safety evaluation of chemicals: The regulatory framework

    Abstract Major industrial countries have relatively recent new laws regulating the manufacture, distribution and use of industrial chemical products. The resultant regulations in the United States

  • long‐term safety evaluation of wiley online library

    Long‐Term Safety Evaluation of Wiley Online Library

    Long‐Term Safety Evaluation of Ubrogepant for the Acute Treatment of Migraine: Phase 3, Randomized, 52‐Week Extension Trial. Jessica Ailani MD. Corresponding Author . E-mail address: jessica.ailani@gmail. Medstar Georgetown University Hospital, Washington, DC, USA. Address all correspondence to J. Ailani, Medstar Georgetown University Hospital, Washington, DC, USA, email:

  • the evaluation of risks of wiley online library

    The evaluation of risks of Wiley Online Library

    Process Safety Progress. Volume 26, Issue 4. The evaluation of risks of ethoxylation reactors. Ernesto Salzano. Corresponding Author. E-mail address: salzano@irc.cnr.it. Istituto di Ricerche sulla Combustione, Consiglio Nazionale delle Ricerche, Via Diocleziano 328, 80124 Napoli, Italy. Istituto di Ricerche sulla Combustione, Consiglio Nazionale delle Ricerche, Via Diocleziano 328, 80124

  • evaluation of the safety wiley online library

    Evaluation of the Safety Wiley Online Library

    No new safety signals were identified for either vital signs or clinical laboratory parameters. A dose‐dependent increase was observed in miridesap exposure (area under the concentration‐time curve and maximum observed drug concentration) in the 10 to 40 mg/h dose range after a 1‐hour IV infusion of miridesap. Rapid depletion of circulating serum amyloid P component was observed after

  • long‐term safety evaluation of wiley online library

    Long‐Term Safety Evaluation of Wiley Online Library

    Long‐Term Safety Evaluation of Ubrogepant for the Acute Treatment of Migraine: Phase 3, Randomized, 52‐Week Extension Trial. Jessica Ailani MD. Corresponding Author . E-mail address: jessica.ailani@gmail. Medstar Georgetown University Hospital, Washington, DC, USA. Address all correspondence to J. Ailani, Medstar Georgetown University Hospital, Washington, DC, USA, email:

  • study on safety evaluation and wiley online library

    Study on safety evaluation and Wiley Online Library

    Safety analysis is used as a key component of design evaluation for examining potential hazards during startup. Potential hazards are eliminated by modifying both plant structure and operating procedures. Issues for both methodology and implementation of a prototype in G2 are discussed. Finally, the system is applied to an industrial hydrodesulfurization process.

  • evaluation of the pharmacokinetic interaction of

    Evaluation of the Pharmacokinetic Interaction of

    Objective. To evaluate the potential for pharmacokinetic interaction and the safety and tolerability when ubrogepant and sumatriptan are coadministered in a Phase 1 study in healthy participants, and to inform the safety and tolerability of ubrogepant alone and in combination with triptans in Phase 3 trials in participants with migraine.

  • evaluation of serious postmarket wiley online library

    Evaluation of Serious Postmarket Wiley Online Library

    Evaluation of Serious Postmarket Safety Signals Within 2 Years of FDA Approval for New Cancer Drugs. Janice Kim. Corresponding Author. E-mail address: janice.kim@fda.hhs.gov. Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA. Correspondence: Janice Kim, Pharm. D., Office of Hematology and Oncology

  • long‐term safety evaluation of wiley online library

    Long‐Term Safety Evaluation of Wiley Online Library

    This phase 3, long‐term safety evaluation followed 813 participants treated intermittently with ubrogepant 50 or 100 mg over the course of 1 year. A total of 21,454 migraine attacks were treated with 31,968 doses of ubrogepant. Participants treated ≥8 migraine attacks with ubrogepant 50 or 100 mg in a total of 144 months. Overall, there was a low incidence of TEAEs, which were mostly mild

  • log in to wiley online library

    Log in to Wiley Online Library

    Medication registries provide important opportunities to evaluate real‐world medication‐related problems. However, underreporting of well‐known problems should be considered. The product design can be used as an (additional) risk mitigation measure to support medication safety in hospital practice.

  • suitability of a generic virus safety evaluation

    Suitability of a generic virus safety evaluation

    Suitability of a generic virus safety evaluation for monoclonal antibody investigational new drug applications. Patrick Sipple. Product Development, Bristol‐Myers Squibb, Princeton, New Jersey . Search for more papers by this author. Tung Nguyen. Product Development, Bristol‐Myers Squibb, Princeton, New Jersey. Search for more papers by this author. Krina Patel. Product Development

  • evaluation of the safety wiley online library

    Evaluation of the Safety Wiley Online Library

    No new safety signals were identified for either vital signs or clinical laboratory parameters. A dose‐dependent increase was observed in miridesap exposure (area under the concentration‐time curve and maximum observed drug concentration) in the 10 to 40 mg/h dose range after a 1‐hour IV infusion of miridesap. Rapid depletion of circulating serum amyloid P component was observed after

  • log in to wiley online library

    Log in to Wiley Online Library

    A follow‐up evaluation (Study 3, n = 138) using the same survey (measuring burnout, physical and mental health, bullying and/or harassment, and safety climate) examined changes over time (analysis of variance) and relative to instrument norms (t tests and chi‐square test).

  • the evaluation of risks of wiley online library

    The evaluation of risks of Wiley Online Library

    Process Safety Progress. Volume 26, Issue 4. The evaluation of risks of ethoxylation reactors. Ernesto Salzano. Corresponding Author. E-mail address: salzano@irc.cnr.it. Istituto di Ricerche sulla Combustione, Consiglio Nazionale delle Ricerche, Via Diocleziano 328, 80124 Napoli, Italy. Istituto di Ricerche sulla Combustione, Consiglio Nazionale delle Ricerche, Via Diocleziano 328, 80124

  • log in to wiley online library

    Log in to Wiley Online Library

    Medication registries provide important opportunities to evaluate real‐world medication‐related problems. However, underreporting of well‐known problems should be considered. The product design can be used as an (additional) risk mitigation measure to support medication safety in hospital practice.

  • log in to wiley online library

    Log in to Wiley Online Library

    A follow‐up evaluation (Study 3, n = 138) using the same survey (measuring burnout, physical and mental health, bullying and/or harassment, and safety climate) examined changes over time (analysis of variance) and relative to instrument norms (t tests and chi‐square test).

  • evaluation of serious postmarket wiley online library

    Evaluation of Serious Postmarket Wiley Online Library

    Evaluation of Serious Postmarket Safety Signals Within 2 Years of FDA Approval for New Cancer Drugs. Janice Kim. Corresponding Author. E-mail address: janice.kim@fda.hhs.gov. Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA. Correspondence: Janice Kim, Pharm. D., Office of Hematology and Oncology

  • evaluation of the safety of drugs wiley online library

    Evaluation of the Safety of Drugs Wiley Online Library

    Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary. J Wang. Office of Drug Evaluation IV, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA . Search for more papers by this author. T Johnson. Division of Pediatric and Maternal Health, Office of Drug Evaluation IV, Center for Drug Evaluation

  • implementation and evaluation of wiley online library

    Implementation and evaluation of Wiley Online Library

    There was high‐fidelity use (median WHOBARS score 5·0 of 7; use of basic safety processes ranged from 85·0 to 99·0 per cent), and high penetration shown by a significant improvement in hospital safety culture (adapted Human Factors Attitude Questionnaire scores of 76·7, 81·1 and 82·2 per cent before, and at 4 and 12–18 months after training respectively; P < 0·001). Acceptability

  • the effect of co‐trimoxazole on wiley online library

    The effect of co‐trimoxazole on Wiley Online Library

    DRUG SAFETY. Free Access. The effect of co‐trimoxazole on serum potassium concentration: safety evaluation of a randomized controlled trial. Wei Yee Chan. Corresponding Author. E-mail address: wychan@doctors.org.uk. Norwich Medical School, University of East Anglia, Norwich, UK . Correspondence. Dr Wei Yee Chan, Norwich Medical School, University of East Anglia, Norwich UK.

  • evaluation of clinical and safety outcomes following

    Evaluation of Clinical and Safety Outcomes Following

    Conflict of interest: RRA serves on the following corporate advisory committees: Sanofi Genzyme Advisory Board and Speakers Bureau, and Veloxis Speakers Bureau, with Research Grants with Bristol Myers Squibb, Hookipa, and Abbvie, which did not interfere with the study design, analysis, interpretation, and publication of the manuscript.

  • evaluation of the safety wiley online library

    Evaluation of the Safety Wiley Online Library

    Evaluation of the Safety, Tolerability, and Pharmacokinetics of GSK2269557 (Nemiralisib) Administered Via Dry Powder Inhaler to Healthy Japanese Subjects. Hiroko Ino . Corresponding Author. E-mail address: hiroko.2.ino@gsk. Medicines Development (Clinical Pharmacology Office), Japan Development Division, GlaxoSmithKline K.K., Tokyo, Japan. Corresponding Author : Hiroko Ino, MPH,

  • log in to wiley online library

    Log in to Wiley Online Library

    A Multiinstitutional Evaluation of the Analgesic Efficacy and Safety of Ketorolac Tromethamine, Acetaminophen plus Codeine, and Placebo in Cancer Pain . Dr. Robert W. Carlson M.D. Corresponding Author. Department of Medicine, Stanford University, Stanford, California. Northern California Oncology Group, Northern California Cancer Center, Belmont, California. Division of Medical Oncology, M211

  • safety evaluation of aflatoxin b1 wiley online library

    Safety evaluation of aflatoxin B1 Wiley Online Library

    Safety evaluation of aflatoxin B 1 in peanut oil after ultraviolet irradiation detoxification in a photodegradation reactor Enjie Diao. College of Food Science & Engineering, Shandong Agricultural University, No. 61, Daizong Street, Taian, 271018 China. Search for more papers by this author. Xiangzhen Shen. College of Food Science & Engineering, Shandong Agricultural University, No. 61