Endocrine Test Protocols
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The Activation of the Glucagon-Like Peptide-1 (GLP-1) Receptor by Peptide and Non-Peptide Ligands
The Activation of the Glucagon-Like Peptide-1 (GLP-1) Receptor by Peptide and Non-Peptide Ligands Clare Louise Wishart Submitted in accordance with the requirements for the degree of Doctor of Philosophy of Science University of Leeds School of Biomedical Sciences Faculty of Biological Sciences September 2013 I Intellectual Property and Publication Statements The candidate confirms that the work submitted is her own and that appropriate credit has been given where reference has been made to the work of others. This copy has been supplied on the understanding that it is copyright material and that no quotation from the thesis may be published without proper acknowledgement. The right of Clare Louise Wishart to be identified as Author of this work has been asserted by her in accordance with the Copyright, Designs and Patents Act 1988. © 2013 The University of Leeds and Clare Louise Wishart. II Acknowledgments Firstly I would like to offer my sincerest thanks and gratitude to my supervisor, Dr. Dan Donnelly, who has been nothing but encouraging and engaging from day one. I have thoroughly enjoyed every moment of working alongside him and learning from his guidance and wisdom. My thanks go to my academic assessor Professor Paul Milner whom I have known for several years, and during my time at the University of Leeds he has offered me invaluable advice and inspiration. Additionally I would like to thank my academic project advisor Dr. Michael Harrison for his friendship, help and advice. I would like to thank Dr. Rosalind Mann and Dr. Elsayed Nasr for welcoming me into the lab as a new PhD student and sharing their experimental techniques with me, these techniques have helped me no end in my time as a research student. -
Metabolism Lectures Diabetes
Metabolism Lectures Diabetes Dalay Olson Ph.D. Integrative Biology and Physiology Email: [email protected] Office: 3-120 Jackson Hall Learning Objectives 1. Compare and contrast type 1 and type 2 diabetes. Identify the major similarities and differences (insulin level, insulin signaling events, treatment options, glucose tolerance test responses etc.) 2. How is diabetes diagnosed in the clinic? What tests are available and commonly used? What information does a glucose tolerance give you? What information does a hemoglobin A1C tell you? What are the limitations of these tests? 3. Explain how chronic elevation of blood glucose levels can result in AGE formation and AGE receptor (RAGE) activation. Explain the downstream effects of RAGE activation. 4. Identify the role of PKC (Protein Kinase C) in arteriolar vasoconstriction in type 2 diabetics. 5. List the common symptoms you might see in the clinic for a patient suffering from type 2 diabetes. 6. Explain why the plasma becomes acidic in a patient with uncontrolled diabetes. 7. Explain the mechanism of action (what is the point of the drug?) of insulin sensitizers, insulin mimetics, insulin secretagogues and SGLT2 inhibitors. Natural Progression of Type-2-Diabetes Pre-diabetes Lean Obese Henry, Am J Med 1998; 105 (1A):20S-6S Think about what is happening with Type 1 diabetics…how does their response differ from that of a normal person? Glucose Insulin is not present, Insulin binds to receptor therefore the signal transduction pathway is not initiated and glucose Glucose transporters remain in enters cell Exocytosis intracellular vesicles. Signal transduction cascade Plasma glucose remains high! GLUT4 Think about what is happening with Type-2-diabetics…how does their response differ from that of a Type-1- diabetic? Glucose Insulin is present but is not Insulin binds to receptor functional, therefore the signal transduction pathway is not initiated and glucose Glucose transporters remain in Exocytosis enters cell intracellular vesicles. -
The National Drugs List
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List of Approved Ndas for Biological Products That Were Deemed to Be Blas on March 23, 2020
List of Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020 On March 23, 2020, an approved application for a biological product under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) was deemed to be a license for the biological product under section 351 of the Public Health Service Act (PHS Act) (see section 7002(e)(4)(A) of the Biologics Price Competition and Innovation Act of 2009). To enhance transparency and facilitate planning for the March 23, 2020, transition date, FDA compiled a preliminary list of approved applications for biological products under the FD&C Act that were listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) and that would be affected by this transition provision. FDA posted this list on the FDA website in December 2018, and periodically updated this list before the March 23, 2020, transition date. The September 2019 update to this preliminary list added certain administratively closed applications related to approved applications for biological products that were on the December 2018 version of this list. The January 2020 update to the preliminary list reflected a change to the definition of “biological product” made by the Further Consolidated Appropriations Act, 2020, which was enacted on December 20, 2019. Section 605 of this Act further amended the definition of a “biological product” in section 351(i) of the PHS Act to remove the parenthetical “(except any chemically synthesized polypeptide)” from the statutory category of “protein.” FDA has provided below a list of each approved application for a biological product under the FD&C Act that was deemed to be a license (i.e., an approved biologics license application (BLA)) for the biological product on March 23, 2020. -
Corticorelin Acetate, a Synthetic Corticotropin-Releasing Factor with Preclinical Antitumor Activity, Alone and with Bevacizumab, Against Human Brain Tumor Models
ANTICANCER RESEARCH 30: 5037-5042 (2010) Corticorelin Acetate, a Synthetic Corticotropin-releasing Factor with Preclinical Antitumor Activity, alone and with Bevacizumab, against Human Brain Tumor Models IDOIA GAMEZ1, ROBERT P. RYAN1 and STEPHEN T. KEIR2 1Celtic Pharmaceutical Development Services America, Inc., New York, NY 10022, U.S.A.; 2The Preston Robert Tisch Brain Tumor Center, Duke University, Durham, NC 27710, U.S.A. Abstract. Background: Corticorelin acetate (CrA) is a brain tumors. The cause of PBE is believed to result in part synthetic form of corticotropin-releasing factor that is from the leakage of edematous brain tumor fluid from currently undergoing clinical trials in the treatment of abnormal tumor vasculature into the surrounding tissue (1, peritumoral brain edema (PBE). This study preclinically 2). The mechanism(s) of action by which CrA exerts its investigated its potential as an antitumor agent against beneficial effect in the therapy of PBE has not been human brain tumor xenografts. Materials and Methods: The elucidated, but two factors appear to be relevant: decreased in vivo efficacy of CrA as a single agent and in combination vascular leakage and preserved integrity of the endothelial with the antiangiogenic agent, bevacizumab, was examined cells, which ultimately helps to maintain the blood-brain in three different patient-derived human brain tumor barrier (3, 4). xenografts implanted orthotopically (intracranially) or CrA appears to mediate its activity through two subtypes subcutaneously in athymic mice. Results: CrA significantly of G-protein coupled receptors: CRF receptor-1 (CRFR1) increased the lifespan of mice implanted orthotopically with and CRF receptor-2 (CRFR2) (5). These CRFRs are widely two different pediatric brain tumor xenograft models. -
1. Two Components, Two Sets of Lecturers
Conditions 1. Two components, two sets of lecturers. 2. Lectures 1-5 Prof. F. Hudecz Lectures 6-9 Dr. Gy. Domány Lectures 10-12 Dr. P. Buzder-Lantos 3. Examination: two parts determined by the lecturers and one mark. - option A: written test - option B: presentation based on literature - option C: oral examination 4. Participation at lectures > 70 % [email protected] Some Approved Peptide Pharmaceuticals and their Methods of Manufacture First generatioin Second generation New generation Oxytocin (L) Carbetocin (S) Abarelix (GnRH) (L) ACTH (1-24) & (1-39) (L,S) Terlipressin (L,S) Cetrorelix (GnRH) (L) Vasopressin (L,S) Felypressin (L,S) Ganirelix (GnRH) (L) Insulin (E,SS, R) Buserelin (L,S) Eptifibatide Glucagon (E,S,R) Deslorelin (L,S) Bivalirudin (L) Calcitonins (L,S,R) Goserelin (L) Copaxone (L) TRH (L) Histrelin (L) Techtide P-289(S) Gonadorelin (L,S) Leuprolide (L,S) Cubicin (F) Somatostatin (L,S) Nafarelin (S) Fuzeon (antiHIV (H) GHRH (1-29) & (1-44) (S) Tryptorelin (L,S) Ziconotide (pain) (S) CRF (Human & Ovine) (S) Lecirelin (S) Pramlintide (diabetes) (S) Cyclosporin (F) Lanreotide (S) Exenatide (diabetes) (S) Thymopentin (L) Octreotide (L,S) Icatibant (brady-rec) Thymosin Alpha-1 (S) Atosiban (L) Romiplostim (hormon) Secretins (Human & Porcine) (E,S) Desmopressin (L,S) Degarelix (GnRH) Parathyroid Hormone (1-34) & (1-84)(S) Lypressin (L) Mifamurtide (rák, adj.) Vasoactive Intestinal Polypeptide (S) Ornipressin Ecallantide (ödéma) Brain Natriuretic Peptide (R) Pitressin (L) Liraglutide (diabetes) Cholecystokinin (L) ACE Inhibitors (Enalapril, Lisinopril) (L) Tesamorelin Tetragastrin (L) HIV Protease Inhibitors (L) Surfaxin Pentagastrin (L) Peginesatide Eledoisin (L) Carfilzomib Linaclotide (enz.inh) L = in solution; S = on solid phase; E = extraction; F = fermentation; H = hybrid synthesis; R = recombinant; SS = semi-synthesis. -
Gastric Secretory and Plasma Hormonal Responses to Sham-Feeding of Varying Duration in Patients with Duodenal Ulcer
Gut: first published as 10.1136/gut.22.12.1003 on 1 December 1981. Downloaded from Gut, 1981, 22,1003-1010 Gastric secretory and plasma hormonal responses to sham-feeding of varying duration in patients with duodenal ulcer S J KONTUREK,* J SWIERCZEK, N KWIECIEN, W OBTUTOWICZ, M DOBRZANSKA, B KOPP, AND J OLEKSY From the Institute ofPhysiology, Medica, Academy, Krakow, and District Hospital, Krakow, Poland SUMMARY Gastric acid and serum gastrin, pancreatic polypeptide, and insulin responses to cephalic vagal stimulation were studied in eight patients with duodenal ulcer using modified sham- feeding for periods varying from four to 30 minutes. In addition, the maximal acid response to sham-feeding was compared with that induced by pentagastrin in 10 healthy subjects and 14 patients with duodenal ulcer. It was found that the gastric acid response to modified sham-feeding reached the maximal value after 15 minutes of sham-feeding and amounted to about 68% of the pentagastrin maximum. The serum pancreatic polypeptide response was also increased after modified sham-feeding and depended on the duration of this procedure, whereas gastrin and insulin responses were not significantly affected by modified sham-feeding. When the peak acid output induced by modified sham-feeding was normalised as percentage of the peak response to pentagastrin, it was similar in healthy subjects and in patients with duodenal ulcer; this indicates that the increased peak acid response to modified sham-feeding observed in patients with duodenal ulcer corresponded with -
BCBSVT Specialty Drug List Effective 2021.07.01.Xlsx
Effective Date: 07/01/2021 SPECIALTY DRUG LIST Revised Date: 05/07/2021 DOSAGE EXCLUDED ON NATIONAL DRUG CLASS DRUG NAME GENERIC NAME FORM PERFORMANCE FORMULARY ANEMIA ARANESP SOLN DARBEPOETIN ALFA SOLN INJ ANEMIA ARANESP SOSY DARBEPOETIN ALFA SOLN PREFILLED SYRINGE ANEMIA EPOGEN SOLN EPOETIN ALFA INJ X ANEMIA PROCRIT SOLN EPOETIN ALFA INJ X ANEMIA REBLOZYL SOLR LUSPATERCEPT-AAMT FOR SUBCUTANEOUS INJ ANEMIA RETACRIT SOLN EPOETIN ALFA-EPBX INJ ANTI-GOUT AGENT KRYSTEXXA SOLN PEGLOTICASE INJ (FOR IV INFUSION) ANTI-INFECTIVE PREVYMIS SOLN LETERMOVIR IV SOLN ANTI-INFECTIVE PREVYMIS TABS LETERMOVIR TAB ASTHMA CINQAIR SOLN RESLIZUMAB IV INFUSION SOLN ASTHMA FASENRA SOSY BENRALIZUMAB SUBCUTANEOUS SOLN PREFILLED SYRINGE ASTHMA FASENRA PEN SOAJ BENRALIZUMAB SUBCUTANEOUS SOLN AUTO-INJECTOR ASTHMA NUCALA SOAJ MEPOLIZUMAB SUBCUTANEOUS SOLUTION AUTO-INJECTOR ASTHMA NUCALA SOLR MEPOLIZUMAB FOR INJ ASTHMA NUCALA SOSY MEPOLIZUMAB SUBCUTANEOUS SOLUTION PREF SYRINGE ASTHMA XOLAIR SOLR OMALIZUMAB FOR INJ ASTHMA XOLAIR SOSY OMALIZUMAB SUBCUTANEOUS SOLN PREFILLED SYRINGE CARDIOVASCULAR VYNDAMAX CAPS TAFAMIDIS CAP CARDIOVASCULAR VYNDAQEL CAPS TAFAMIDIS MEGLUMINE (CARDIAC) CAP CENTRAL NERVOUS SYSTEM AGENTS AUSTEDO TABS DEUTETRABENAZINE TAB CENTRAL NERVOUS SYSTEM AGENTS ENSPRYNG SOSY SATRALIZUMAB-MWGE SUBCUTANEOUS SOLN PREF SYRINGE CENTRAL NERVOUS SYSTEM AGENTS HETLIOZ CAPS TASIMELTEON CAPSULE CENTRAL NERVOUS SYSTEM AGENTS HETLIOZ LQ SUSP TASIMELTEON ORAL SUSP CHEMOTHERAPY PROTECTANT AMIFOSTINE SOLR AMIFOSTINE CRYSTALLINE FOR INJ CHEMOTHERAPY PROTECTANT ELITEK -
Preferred Drug List (Formulary)
January 2020 Molina Healthcare of Michigan Preferred Drug List (Formulary) 1 Molina Healthcare of Michigan Preferred Drug List (Formulary) (01/01/2020) INTRODUCTION ..........................................................................................................................................................................................................................................5 PREFACE .....................................................................................................................................................................................................................................................5 PHARMACY AND THERAPEUTICS (P&T) COMMITTEE ..........................................................................................................................................................................5 DRUG LIST PRODUCT DESCRIPTIONS ...................................................................................................................................................................................................5 GENERIC SUBSTITUTION ..........................................................................................................................................................................................................................5 PLAN DESIGN .............................................................................................................................................................................................................................................6 -
Title 16. Crimes and Offenses Chapter 13. Controlled Substances Article 1
TITLE 16. CRIMES AND OFFENSES CHAPTER 13. CONTROLLED SUBSTANCES ARTICLE 1. GENERAL PROVISIONS § 16-13-1. Drug related objects (a) As used in this Code section, the term: (1) "Controlled substance" shall have the same meaning as defined in Article 2 of this chapter, relating to controlled substances. For the purposes of this Code section, the term "controlled substance" shall include marijuana as defined by paragraph (16) of Code Section 16-13-21. (2) "Dangerous drug" shall have the same meaning as defined in Article 3 of this chapter, relating to dangerous drugs. (3) "Drug related object" means any machine, instrument, tool, equipment, contrivance, or device which an average person would reasonably conclude is intended to be used for one or more of the following purposes: (A) To introduce into the human body any dangerous drug or controlled substance under circumstances in violation of the laws of this state; (B) To enhance the effect on the human body of any dangerous drug or controlled substance under circumstances in violation of the laws of this state; (C) To conceal any quantity of any dangerous drug or controlled substance under circumstances in violation of the laws of this state; or (D) To test the strength, effectiveness, or purity of any dangerous drug or controlled substance under circumstances in violation of the laws of this state. (4) "Knowingly" means having general knowledge that a machine, instrument, tool, item of equipment, contrivance, or device is a drug related object or having reasonable grounds to believe that any such object is or may, to an average person, appear to be a drug related object. -
ACTH Stimulation Tests for the Diagnosis of Adrenal Insufficiency: Systematic Review and Meta-Analysis
ORIGINAL ARTICLE ACTH Stimulation Tests for the Diagnosis of Adrenal Insufficiency: Systematic Review and Meta-Analysis Naykky Singh Ospina,* Alaa Al Nofal,* Irina Bancos, Asma Javed, Khalid Benkhadra, Ekta Kapoor, Aida N. Lteif, Neena Natt, and M. Hassan Murad Evidence-Based Practice Research Program (N.S.O., A.A.N., K.B., M.H.M.), Mayo Clinic, Rochester, Downloaded from https://academic.oup.com/jcem/article/101/2/427/2810551 by guest on 29 September 2021 Minnesota; Knowledge and Evaluation Research Unit (N.S.O., K.B., M.H.M.), Mayo Clinic, Rochester, Minnesota; Division of Endocrinology, Diabetes, Metabolism, and Nutrition (N.S.O., N.N., I.B.), Mayo Clinic, Rochester, Minnesota; Division of Pediatric Endocrinology and Metabolism (A.A.N., A.J., A.N.L.), Mayo Clinic, Rochester, Minnesota; Division of General Internal Medicine (E.K.), Mayo Clinic, Rochester, Minnesota 55905 Context: The diagnosis of adrenal insufficiency is clinically challenging and often requires ACTH stimulation tests. Objective: To determine the diagnostic accuracy of the high- (250 mcg) and low- (1 mcg) dose ACTH stimulation tests in the diagnosis of adrenal insufficiency. Methods: We searched six databases through February 2014. Pairs of independent reviewers se- lected studies and appraised the risk of bias. Diagnostic association measures were pooled across studies using a bivariate model. Data Synthesis: For secondary adrenal insufficiency, we included 30 studies enrolling 1209 adults and 228 children. High- and low-dose ACTH stimulation tests had similar diagnostic accuracy in adults and children using different peak serum cortisol cutoffs. In general, both tests had low sensitivity and high specificity resulting in reasonable likelihood ratios for a positive test (adults: high dose, 9.1; low dose, 5.9; children: high dose, 43.5; low dose, 7.7), but a fairly suboptimal likelihood ratio for a negative test (adults: high dose, 0.39; low dose, 0.19; children: high dose, 0.65; low dose, 0.34). -
Study Protocol
Cover Page for Protocol Sponsor name: Novo Nordisk A/S NCT number NCT02501161 Sponsor trial ID: NN9068-4228 Official title of study: A 104 week clinical trial comparing long term glycaemic control of insulin degludec/liraglutide (IDegLira) versus insulin glargine therapy in subjects with type 2 diabetes mellitus (DUAL™ VIII) Document date: 01 March 2019 IDegLira Date: 01 March 2019 Novo Nordisk Trial ID: NN9068-4228 Version: 1.0 CONFIDENTIAL Clinical Trial Report Status: Final Appendix 16.1.1 16.1.1 Protocol and protocol amendments List of contents Protocol ............................................................................................................................................... Link Appendix A ......................................................................................................................................... Link Appendix B................................................................................................ .......................................... Link Attachment I and II............................................................................................................................ Link Protocol amendment 1 - MX ................................................................ ............................................. Link Protocol amendment 2 - NO.............................................................................................................. Link Protocol amendment 3 - Global/HQ ................................................................................................