Restoring Youth
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UFC PROHIBITED LIST Effective June 1, 2021 the UFC PROHIBITED LIST
UFC PROHIBITED LIST Effective June 1, 2021 THE UFC PROHIBITED LIST UFC PROHIBITED LIST Effective June 1, 2021 PART 1. Except as provided otherwise in PART 2 below, the UFC Prohibited List shall incorporate the most current Prohibited List published by WADA, as well as any WADA Technical Documents establishing decision limits or reporting levels, and, unless otherwise modified by the UFC Prohibited List or the UFC Anti-Doping Policy, Prohibited Substances, Prohibited Methods, Specified or Non-Specified Substances and Specified or Non-Specified Methods shall be as identified as such on the WADA Prohibited List or WADA Technical Documents. PART 2. Notwithstanding the WADA Prohibited List and any otherwise applicable WADA Technical Documents, the following modifications shall be in full force and effect: 1. Decision Concentration Levels. Adverse Analytical Findings reported at a concentration below the following Decision Concentration Levels shall be managed by USADA as Atypical Findings. • Cannabinoids: natural or synthetic delta-9-tetrahydrocannabinol (THC) or Cannabimimetics (e.g., “Spice,” JWH-018, JWH-073, HU-210): any level • Clomiphene: 0.1 ng/mL1 • Dehydrochloromethyltestosterone (DHCMT) long-term metabolite (M3): 0.1 ng/mL • Selective Androgen Receptor Modulators (SARMs): 0.1 ng/mL2 • GW-1516 (GW-501516) metabolites: 0.1 ng/mL • Epitrenbolone (Trenbolone metabolite): 0.2 ng/mL 2. SARMs/GW-1516: Adverse Analytical Findings reported at a concentration at or above the applicable Decision Concentration Level but under 1 ng/mL shall be managed by USADA as Specified Substances. 3. Higenamine: Higenamine shall be a Prohibited Substance under the UFC Anti-Doping Policy only In-Competition (and not Out-of- Competition). -
Fully Automated Dried Blood Spot Sample Preparation Enables the Detection of Lower Molecular Mass Peptide and Non-Peptide Doping Agents by Means of LC-HRMS
Analytical and Bioanalytical Chemistry (2020) 412:3765–3777 https://doi.org/10.1007/s00216-020-02634-4 RESEARCH PAPER Fully automated dried blood spot sample preparation enables the detection of lower molecular mass peptide and non-peptide doping agents by means of LC-HRMS Tobias Lange1 & Andreas Thomas1 & Katja Walpurgis1 & Mario Thevis1,2 Received: 10 December 2019 /Revised: 26 March 2020 /Accepted: 31 March 2020 # The Author(s) 2020 Abstract The added value of dried blood spot (DBS) samples complementing the information obtained from commonly routine doping control matrices is continuously increasing in sports drug testing. In this project, a robotic-assisted non-destructive hematocrit measurement from dried blood spots by near-infrared spectroscopy followed by a fully automated sample preparation including strong cation exchange solid-phase extraction and evaporation enabled the detection of 46 lower molecular mass (< 2 kDa) peptide and non-peptide drugs and drug candidates by means of LC-HRMS. The target analytes included, amongst others, agonists of the gonadotropin-releasing hormone receptor, the ghrelin receptor, the human growth hormone receptor, and the antidiuretic hormone receptor. Furthermore, several glycine derivatives of growth hormone–releasing peptides (GHRPs), argu- ably designed to undermine current anti-doping testing approaches, were implemented to the presented detection method. The initial testing assay was validated according to the World Anti-Doping Agency guidelines with estimated LODs between 0.5 and 20 ng/mL. As a proof of concept, authentic post-administration specimens containing GHRP-2 and GHRP-6 were successfully analyzed. Furthermore, DBS obtained from a sampling device operating with microneedles for blood collection from the upper arm were analyzed and the matrix was cross-validated for selected parameters. -
To Download a List of Prescription Drugs Requiring Prior Authorization
Essential Health Benefits Standard Specialty PA and QL List July 2016 The following products require prior authorization. In addition, there may be quantity limits for these drugs, which is notated below. Therapeutic Category Drug Name Quantity Limit Anti-infectives Antiretrovirals, HIV SELZENTRY (maraviroc) None Cardiology Antilipemic JUXTAPID (lomitapide) 1 tab/day PRALUENT (alirocumab) 2 syringes/28 days REPATHA (evolocumab) 3 syringes/28 days Pulmonary Arterial Hypertension ADCIRCA (tadalafil) 2 tabs/day ADEMPAS (riociguat) 3 tabs/day FLOLAN (epoprostenol) None LETAIRIS (ambrisentan) 1 tab/day OPSUMIT (macitentan) 1 tab/day ORENITRAM (treprostinil diolamine) None REMODULIN (treprostinil) None REVATIO (sildenafil) Soln None REVATIO (sildenafil) Tabs 3 tabs/day TRACLEER (bosentan) 2 tabs/day TYVASO (treprostinil) 1 ampule/day UPTRAVI (selexipag) 2 tabs/day UPTRAVI (selexipag) Pack 2 packs/year VELETRI (epoprostenol) None VENTAVIS (iloprost) 9 ampules/day Central Nervous System Anticonvulsants SABRIL (vigabatrin) pack None Depressant XYREM (sodium oxybate) 3 bottles (540 mL)/30 days Neurotoxins BOTOX (onabotulinumtoxinA) None DYSPORT (abobotulinumtoxinA) None MYOBLOC (rimabotulinumtoxinB) None XEOMIN (incobotulinumtoxinA) None Parkinson's APOKYN (apomorphine) 20 cartridges/30 days Sleep Disorder HETLIOZ (tasimelteon) 1 cap/day Dermatology Alkylating Agents VALCHLOR (mechlorethamine) Gel None Electrolyte & Renal Agents Diuretics KEVEYIS (dichlorphenamide) 4 tabs/day Endocrinology & Metabolism Gonadotropins ELIGARD (leuprolide) 22.5 mg -
Effect of Ghrelin Receptor Ligands on Proliferation of Prostate Stromal Cells and on Smooth Muscle Contraction in the Human Prostate
Aus der Urologischen Klinik und Poliklinik der Ludwig-Maximilians-Universität München Direktor: Prof. Dr. Christian G. Stief Effect of ghrelin receptor ligands on proliferation of prostate stromal cells and on smooth muscle contraction in the human prostate Dissertation zum Erwerb des Doktorgrades der Medizin an der Medizinischen Fakultät der Ludwig-Maximilians-Universität zu München vorgelegt von Xiaolong Wang aus Wuhan, China 2020 Mit Genehmigung der Medizinischen Fakultät der Universität München Berichterstatter: Prof. Dr. rer. nat. Martin Hennenberg Mitberichterstatter: PD Dr. Heike Pohla Prof. Dr. Wolf Mutschler Dekan: Prof. Dr. med. dent. Reinhard Hickel Tag der mündlichen Prüfung: 20.02.2020 1. Introduction ........................................................................................ 1 1.1 Definition of LUTS .......................................................................... 1 1.2 Epidemiology, etiology and nature history of LUTS ................... 2 1.3 Pathogenesis of LUTS suggestive to BPH ..................................... 4 1.3.1 Age .............................................................................................. 6 1.3.2 Inflammation ............................................................................... 6 1.3.3 Sex hormones .............................................................................. 7 1.3.4. Metabolic factors ....................................................................... 7 1.3.5 Other urologic diseases associated with LUTS .......................... 9 -
( 12 ) United States Patent
US010317418B2 (12 ) United States Patent ( 10 ) Patent No. : US 10 ,317 ,418 B2 Goosens (45 ) Date of Patent: * Jun . 11 , 2019 (54 ) USE OF GHRELIN OR FUNCTIONAL 7 , 479 ,271 B2 1 / 2009 Marquis et al . GHRELIN RECEPTOR AGONISTS TO 7 ,632 , 809 B2 12 / 2009 Chen 7 ,666 , 833 B2 2 /2010 Ghigo et al. PREVENT AND TREAT STRESS -SENSITIVE 7 , 901 ,679 B2 3 / 2011 Marquis et al . PSYCHIATRIC ILLNESS 8 ,013 , 015 B2 9 / 2011 Harran et al . 8 ,293 , 709 B2 10 /2012 Ross et al . (71 ) Applicant: Massachusetts Institute of 9 ,724 , 396 B2 * 8 / 2017 Goosens A61K 38 /27 9 , 821 ,042 B2 * 11 /2017 Goosens .. A61K 39/ 0005 Technology , Cambridge , MA (US ) 10 , 039 ,813 B2 8 / 2018 Goosens 2002/ 0187938 A1 12 / 2002 Deghenghi (72 ) Inventor : Ki Ann Goosens, Cambridge , MA (US ) 2003 / 0032636 Al 2 /2003 Cremers et al. 2004 / 0033948 Al 2 / 2004 Chen ( 73 ) Assignee : Massachusetts Institute of 2005 / 0070712 A1 3 /2005 Kosogof et al. Technology , Cambridge , MA (US ) 2005 / 0148515 Al 7/ 2005 Dong 2005 / 0187237 A1 8 / 2005 Distefano et al. 2005 /0191317 A1 9 / 2005 Bachmann et al. ( * ) Notice : Subject to any disclaimer , the term of this 2005 /0201938 A1 9 /2005 Bryant et al. patent is extended or adjusted under 35 2005 /0257279 AL 11 / 2005 Qian et al. U . S . C . 154 ( b ) by 0 days. 2006 / 0025344 Al 2 /2006 Lange et al. 2006 / 0025566 A 2 /2006 Hoveyda et al. This patent is subject to a terminal dis 2006 / 0293370 AL 12 / 2006 Saunders et al . -
Assessment Report
15 November 2018 EMA/CHMP/845216/2018 Committee for Medicinal Products for Human Use (CHMP) Assessment report Macimorelin Aeterna Zentaris International non-proprietary name: macimorelin Procedure No. EMEA/H/C/004660/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Background information on the procedure .............................................. 6 1.1. Submission of the dossier ...................................................................................... 6 1.2. Steps taken for the assessment of the product ......................................................... 7 2. Scientific discussion ................................................................................ 8 2.1. Problem statement ............................................................................................... 8 2.1.1. Disease or condition ........................................................................................... 8 2.1.1. Epidemiology .................................................................................................... 8 2.1.2. Aetiology and pathogenesis ............................................................................... -
VIII. Hypothalamo Pituitary Axis Bone Turnover
Drugs affecting the hypothalamic – pituitary axis Regina Demlová, FÚ LF MU The hypothalamo-pituitary axis is the unit formed by the hypothalamus and pituitary gland , which exerts control over many parts of the endocrine system. the nervous system regulates the endocrine system and endocrine activity modulates the activity of the CNS. Hormones (peptides) – receptors – muscles, bones, fat tissue A/ membrane R → AC – catalyze the conversion of ATP to cAMP and pyrophosphate - a regulatory signal via specific cAMP-binding proteins, either transcription factors or other enzymes (e.g., cAMP- dependent kinases). B/ cytosolic receptor → translocation to the nucleus in a form capable of interacting with the DNA. Controlling the hypothalamic-pituitary-target organ axis : . important factor Negative feedback the action of hypothalamic hormones may be inhibited : A/ by long feedback patway from the target gland hormone or B/ by short feedback pathway from the pituitary hormone. There may also be direct feedback from the target gland hormone to the pituitary gland. Input is also received at the hypothalamus from higher brain centres Negative feedback CNS (sensoric, psychogenic) HYPOTHALAMIC HORMONES Releasing factors Long negative „feedback“ pathway Short negative „feedback“ pathway PITUITARY GLAND „trophs“ TSH ACTH FSH LH peripheral endocrine tissue gland Endocrinopathy • any disease due to disorder of the endocrine system A. the hypothalamic-pituitary-target organ axis • Peripheral - primary - arise at the level of peripheral endocrine.glands -
Growth Hormone Secretagogues: History, Mechanism of Action and Clinical Development
Growth hormone secretagogues: history, mechanism of action and clinical development Junichi Ishida1, Masakazu Saitoh1, Nicole Ebner1, Jochen Springer1, Stefan D Anker1, Stephan von Haehling 1 , Department of Cardiology and Pneumology, University Medical Center Göttingen, Göttingen, Germany Abstract Growth hormone secretagogues (GHSs) are a generic term to describe compounds which increase growth hormone (GH) release. GHSs include agonists of the growth hormone secretagogue receptor (GHS‐R), whose natural ligand is ghrelin, and agonists of the growth hormone‐releasing hormone receptor (GHRH‐R), to which the growth hormone‐ releasing hormone (GHRH) binds as a native ligand. Several GHSs have been developed with a view to treating or diagnosisg of GH deficiency, which causes growth retardation, gastrointestinal dysfunction and altered body composition, in parallel with extensive research to identify GHRH, GHS‐R and ghrelin. This review will focus on the research history and the pharmacology of each GHS, which reached randomized clinical trials. Furthermore, we will highlight the publicly disclosed clinical trials regarding GHSs. Address for correspondence: Corresponding author: Stephan von Haehling, MD, PhD Department of Cardiology and Pneumology, University Medical Center Göttingen, Göttingen, Germany Robert‐Koch‐Strasse 40, 37075 Göttingen, Germany, Tel: +49 (0) 551 39‐20911, Fax: +49 (0) 551 39‐20918 E‐mail: [email protected]‐goettingen.de Key words: GHRPs, GHSs, Ghrelin, Morelins, Body composition, Growth hormone deficiency, Received 10 September 2018 Accepted 07 November 2018 1. Introduction testing in clinical trials. A vast array of indications of ghrelin receptor agonists has been evaluated including The term growth hormone secretagogues growth retardation, gastrointestinal dysfunction, and (GHSs) embraces compounds that have been developed altered body composition, some of which have received to increase growth hormone (GH) release. -
CS/HB 1041 Controlled Substances SPONSOR(S): Criminal Justice Subcommittee; Berman TIED BILLS: IDEN./SIM
HOUSE OF REPRESENTATIVES STAFF ANALYSIS BILL #: CS/HB 1041 Controlled Substances SPONSOR(S): Criminal Justice Subcommittee; Berman TIED BILLS: IDEN./SIM. BILLS: CS/SB 1448 REFERENCE ACTION ANALYST STAFF DIRECTOR or BUDGET/POLICY CHIEF 1) Criminal Justice Subcommittee 13 Y, 0 N, As Jones Cunningham CS 2) Justice Appropriations Subcommittee 3) Judiciary Committee SUMMARY ANALYSIS Chapter 893, F.S., sets forth the Florida Comprehensive Drug Abuse Prevention and Control Act and classifies controlled substances into five categories, known as schedules. These schedules are used to regulate the manufacture, distribution, preparation and dispensing of the substances listed therein. The distinguishing factors between the different drug schedules are the “potential for abuse” of the substance listed therein and whether there is a currently accepted medical use for the substance. Schedule III substances have a potential for abuse less than the substances contained in schedules I and II, and have an accepted medical use in treatment in the United States. Some examples of schedule III substances are barbituric acid, nalorphine, and anabolic steroids. The bill amends s. 893.03(3), F.S., to add the following substances to schedule III of Florida’s controlled substance schedules: hCG; CJC-1295; GHRH; GHRP-6; HGH; Somatropin; and Tesamorelin. As a result, the criminal penalties relating to the possession, sale, manufacture, delivery, etc. of schedule III controlled substances will apply to these newly added substances. The bill will likely have a negative fiscal impact on the Florida Department of Law Enforcement and the Department of Corrections. See fiscal section. The bill is effective on October 1, 2013. -
(12) Patent Application Publication (10) Pub. No.: US 2016/0243197 A1 G00 Sens (43) Pub
US 20160243 197A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2016/0243197 A1 G00 sens (43) Pub. Date: Aug. 25, 2016 (54) USE OF GHRELIN ORFUNCTIONAL Publication Classification GHRELIN RECEPTORAGONSTS TO PREVENT AND TREAT STRESS-SENSITIVE (51) Int. Cl. PSYCHATRC LLNESS A638/22 (2006.01) GOIN33/74 (2006.01) (71) Applicant: Massachusetts Institute of Technology, A613 L/435 (2006.01) Cambridge, MA (US) (52) U.S. Cl. CPC ............... A61K 38/22 (2013.01); A61 K3I/435 (72) Inventor: Ki Ann Goosens, Cambridge, MA (US) (2013.01); G0IN33/74 (2013.01); G0IN (73) Assignee: Massachusetts Institute of Technology, 2800/7004 (2013.01); G0IN 2800/54 (2013.01); Cambridge, MA (US) G0IN 2333/575 (2013.01) (21) Appl. No.: 15/052,110 (57) ABSTRACT (22) Filed: Feb. 24, 2016 The invention relates to methods of treating stress-sensitive psychiatric diseases arising from trauma in a Subject by Related U.S. Application Data enhancing ghrelin signaling in the BLA of the Subject. The (60) Provisional application No. 62/119,898, filed on Feb. invention also relates to methods of reversing ghrelin resis 24, 2015. tance. Patent Application Publication Aug. 25, 2016 Sheet 1 of 18 US 2016/0243.197 A1 itediate Baseline Sarapie Auditory fear critioning Sarpie at 8, it, 36, 60, i28, atti i8 it long-term context long-terra Aisitory ear Recai Fair Recai F.G. 1A Patent Application Publication Aug. 25, 2016 Sheet 2 of 18 US 2016/0243.197 A1 10. a 30 s t 60 5 40 s { 200 t 3. 2 8 Minutes. -
Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Updated June 07, 2021 Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Three categories of bulk drug substances: • Category 1: Bulk Drug Substances Under Evaluation • Category 2: Bulk Drug Substances that Raise Significant Safety Risks • Category 3: Bulk Drug Substances Nominated Without Adequate Support Updates to Categories of Substances Nominated for the 503B Bulk Drug Substances List1 • Add the following entry to category 2 due to serious safety concerns of mutagenicity, cytotoxicity, and possible carcinogenicity when quinacrine hydrochloride is used for intrauterine administration for non- surgical female sterilization: 2,3 o Quinacrine Hydrochloride for intrauterine administration • Revision to category 1 for clarity: o Modify the entry for “Quinacrine Hydrochloride” to “Quinacrine Hydrochloride (except for intrauterine administration).” • Revision to category 1 to correct a substance name error: o Correct the error in the substance name “DHEA (dehydroepiandosterone)” to “DHEA (dehydroepiandrosterone).” 1 For the purposes of the substance names in the categories, hydrated forms of the substance are included in the scope of the substance name. 2 Quinacrine HCl was previously reviewed in 2016 as part of FDA’s consideration of this bulk drug substance for inclusion on the 503A Bulks List. As part of this review, the Division of Bone, Reproductive and Urologic Products (DBRUP), now the Division of Urology, Obstetrics and Gynecology (DUOG), evaluated the nomination of quinacrine for intrauterine administration for non-surgical female sterilization and recommended that quinacrine should not be included on the 503A Bulks List for this use. This recommendation was based on the lack of information on efficacy comparable to other available methods of female sterilization and serious safety concerns of mutagenicity, cytotoxicity and possible carcinogenicity in use of quinacrine for this indication and route of administration. -
2019 Prohibited List
THE WORLD ANTI-DOPING CODE INTERNATIONAL STANDARD PROHIBITED LIST JANUARY 2019 The official text of the Prohibited List shall be maintained by WADA and shall be published in English and French. In the event of any conflict between the English and French versions, the English version shall prevail. This List shall come into effect on 1 January 2019 SUBSTANCES & METHODS PROHIBITED AT ALL TIMES (IN- AND OUT-OF-COMPETITION) IN ACCORDANCE WITH ARTICLE 4.2.2 OF THE WORLD ANTI-DOPING CODE, ALL PROHIBITED SUBSTANCES SHALL BE CONSIDERED AS “SPECIFIED SUBSTANCES” EXCEPT SUBSTANCES IN CLASSES S1, S2, S4.4, S4.5, S6.A, AND PROHIBITED METHODS M1, M2 AND M3. PROHIBITED SUBSTANCES NON-APPROVED SUBSTANCES Mestanolone; S0 Mesterolone; Any pharmacological substance which is not Metandienone (17β-hydroxy-17α-methylandrosta-1,4-dien- addressed by any of the subsequent sections of the 3-one); List and with no current approval by any governmental Metenolone; regulatory health authority for human therapeutic use Methandriol; (e.g. drugs under pre-clinical or clinical development Methasterone (17β-hydroxy-2α,17α-dimethyl-5α- or discontinued, designer drugs, substances approved androstan-3-one); only for veterinary use) is prohibited at all times. Methyldienolone (17β-hydroxy-17α-methylestra-4,9-dien- 3-one); ANABOLIC AGENTS Methyl-1-testosterone (17β-hydroxy-17α-methyl-5α- S1 androst-1-en-3-one); Anabolic agents are prohibited. Methylnortestosterone (17β-hydroxy-17α-methylestr-4-en- 3-one); 1. ANABOLIC ANDROGENIC STEROIDS (AAS) Methyltestosterone; a. Exogenous*