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Lifestyle Drugs” for Men and Women
Development of “Lifestyle Drugs” for Men and Women Armin Schultz CRS - Clinical Research Services Mannheim GmbH AGAH Annual Meeting 2012, Leipzig, March 01 - 02 Lifestyle drugs Smart drugs, Quality-of-life drugs, Vanity drugs etc. Lifestyle? Lifestyle-Drugs? Active development? Discovery by chance? AGAH Annual Meeting 2012, Leipzig, March 01 - 02 Lifestyle A lifestyle is a characteristic bundle of behaviors that makes sense to both others and oneself in a given time and place, including social relations, consumption, entertainment, and dress. The behaviors and practices within lifestyles are a mixture of habits, conventional ways of doing things, and reasoned actions „Ein Lebensstil ist [...] der regelmäßig wiederkehrende Gesamtzusammenhang der Verhaltensweisen, Interaktionen, Meinungen, Wissensbestände und bewertenden Einstellungen eines Menschen“ (Hradil 2005: 46) Different definitions in social sciences, philosophy, psychology or medicine AGAH Annual Meeting 2012, Leipzig, March 01 - 02 Lifestyle Many “subdivisions” LOHAS: “Lifestyles of Health and Sustainability“ LOVOS: “Lifestyles of Voluntary Simplicity“ SLOHAS: “Slow Lifestyles of Happiness and Sustainability” PARKOS: “Partizipative Konsumenten“ ……. ……. ……. AGAH Annual Meeting 2012, Leipzig, March 01 - 02 Lifestyle drugs Lifestyle drug is an imprecise term commonly applied to medications which treat non-life threatening and non-painful conditions such as baldness, impotence, wrinkles, or acne, without any medical relevance at all or only minor medical relevance relative to others. Desire for increase of personal well-being and quality of life It is sometimes intended as a pejorative, bearing the implication that the scarce medical research resources allocated to develop such drugs were spent frivolously when they could have been better spent researching cures for more serious medical conditions. -
Choline for a Healthy Pregnancy
To support healthy for a Healthy weight gain and keep up with the nutritional needs of both mom and Pregnancy the developing baby, CHOLINE additional nutrients are necessary. Nine out of 10 Americans don’t meet the daily recommended choline intake of 550 mg1,2 and it can be challenging to reach this goal even when choosing choline-containing foods like beef, eggs, wheat germ and Brussels sprouts. Choline is particularly important during pregnancy for both mom and baby because it supports healthy brain growth and offers protection against neural tube defects. Women are encouraged to take a prenatal supplement before and during pregnancy to ensure they’re meeting vitamin and mineral recommendations. In fact, the American Medical Association recommends that choline be included in all prenatal vitamins to help ensure women get enough choline to maintain a normal pregnancy.3 Look for a prenatal supplement that contains folic acid, iron, DHA (omega-3s), vitamin D and choline. Consider smart swaps to get the most choline in your diet for a healthy pregnancy, as well as optimal health after baby arrives. PREGNANCY EATING PATTERN* CHOLINE-FOCUSED PREGNANCY EATING PATTERN* 1 1 hard-cooked egg 1 2 cups toasted whole grain oat cereal / 1 large peach 1 cup nonfat milk 1 1 slice whole grain bread /3 cup blueberries 1 1 tablespoon jelly /3 cup sliced banana BREAKFAST 1 cup nonfat milk 1 /2 whole grain bagel 1 whole wheat tortilla 2 tablespoons peanut butter 2 tablespoons peanut butter 1 small apple 1 SNACK 1 /2 large banana /2 cup nonfat vanilla Greek yogurt 2 slices whole grain bread 3 oz. -
(12) Patent Application Publication (10) Pub. No.: US 2006/0110428A1 De Juan Et Al
US 200601 10428A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2006/0110428A1 de Juan et al. (43) Pub. Date: May 25, 2006 (54) METHODS AND DEVICES FOR THE Publication Classification TREATMENT OF OCULAR CONDITIONS (51) Int. Cl. (76) Inventors: Eugene de Juan, LaCanada, CA (US); A6F 2/00 (2006.01) Signe E. Varner, Los Angeles, CA (52) U.S. Cl. .............................................................. 424/427 (US); Laurie R. Lawin, New Brighton, MN (US) (57) ABSTRACT Correspondence Address: Featured is a method for instilling one or more bioactive SCOTT PRIBNOW agents into ocular tissue within an eye of a patient for the Kagan Binder, PLLC treatment of an ocular condition, the method comprising Suite 200 concurrently using at least two of the following bioactive 221 Main Street North agent delivery methods (A)-(C): Stillwater, MN 55082 (US) (A) implanting a Sustained release delivery device com (21) Appl. No.: 11/175,850 prising one or more bioactive agents in a posterior region of the eye so that it delivers the one or more (22) Filed: Jul. 5, 2005 bioactive agents into the vitreous humor of the eye; (B) instilling (e.g., injecting or implanting) one or more Related U.S. Application Data bioactive agents Subretinally; and (60) Provisional application No. 60/585,236, filed on Jul. (C) instilling (e.g., injecting or delivering by ocular ion 2, 2004. Provisional application No. 60/669,701, filed tophoresis) one or more bioactive agents into the Vit on Apr. 8, 2005. reous humor of the eye. Patent Application Publication May 25, 2006 Sheet 1 of 22 US 2006/0110428A1 R 2 2 C.6 Fig. -
(19) United States (12) Patent Application Publication (10) Pub
US 20130289061A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2013/0289061 A1 Bhide et al. (43) Pub. Date: Oct. 31, 2013 (54) METHODS AND COMPOSITIONS TO Publication Classi?cation PREVENT ADDICTION (51) Int. Cl. (71) Applicant: The General Hospital Corporation, A61K 31/485 (2006-01) Boston’ MA (Us) A61K 31/4458 (2006.01) (52) U.S. Cl. (72) Inventors: Pradeep G. Bhide; Peabody, MA (US); CPC """"" " A61K31/485 (201301); ‘4161223011? Jmm‘“ Zhu’ Ansm’ MA. (Us); USPC ......... .. 514/282; 514/317; 514/654; 514/618; Thomas J. Spencer; Carhsle; MA (US); 514/279 Joseph Biederman; Brookline; MA (Us) (57) ABSTRACT Disclosed herein is a method of reducing or preventing the development of aversion to a CNS stimulant in a subject (21) App1_ NO_; 13/924,815 comprising; administering a therapeutic amount of the neu rological stimulant and administering an antagonist of the kappa opioid receptor; to thereby reduce or prevent the devel - . opment of aversion to the CNS stimulant in the subject. Also (22) Flled' Jun‘ 24’ 2013 disclosed is a method of reducing or preventing the develop ment of addiction to a CNS stimulant in a subj ect; comprising; _ _ administering the CNS stimulant and administering a mu Related U‘s‘ Apphcatlon Data opioid receptor antagonist to thereby reduce or prevent the (63) Continuation of application NO 13/389,959, ?led on development of addiction to the CNS stimulant in the subject. Apt 27’ 2012’ ?led as application NO_ PCT/US2010/ Also disclosed are pharmaceutical compositions comprising 045486 on Aug' 13 2010' a central nervous system stimulant and an opioid receptor ’ antagonist. -
Customs Tariff - Schedule
CUSTOMS TARIFF - SCHEDULE 99 - i Chapter 99 SPECIAL CLASSIFICATION PROVISIONS - COMMERCIAL Notes. 1. The provisions of this Chapter are not subject to the rule of specificity in General Interpretative Rule 3 (a). 2. Goods which may be classified under the provisions of Chapter 99, if also eligible for classification under the provisions of Chapter 98, shall be classified in Chapter 98. 3. Goods may be classified under a tariff item in this Chapter and be entitled to the Most-Favoured-Nation Tariff or a preferential tariff rate of customs duty under this Chapter that applies to those goods according to the tariff treatment applicable to their country of origin only after classification under a tariff item in Chapters 1 to 97 has been determined and the conditions of any Chapter 99 provision and any applicable regulations or orders in relation thereto have been met. 4. The words and expressions used in this Chapter have the same meaning as in Chapters 1 to 97. Issued January 1, 2020 99 - 1 CUSTOMS TARIFF - SCHEDULE Tariff Unit of MFN Applicable SS Description of Goods Item Meas. Tariff Preferential Tariffs 9901.00.00 Articles and materials for use in the manufacture or repair of the Free CCCT, LDCT, GPT, UST, following to be employed in commercial fishing or the commercial MT, MUST, CIAT, CT, harvesting of marine plants: CRT, IT, NT, SLT, PT, COLT, JT, PAT, HNT, Artificial bait; KRT, CEUT, UAT, CPTPT: Free Carapace measures; Cordage, fishing lines (including marlines), rope and twine, of a circumference not exceeding 38 mm; Devices for keeping nets open; Fish hooks; Fishing nets and netting; Jiggers; Line floats; Lobster traps; Lures; Marker buoys of any material excluding wood; Net floats; Scallop drag nets; Spat collectors and collector holders; Swivels. -
(12) United States Patent (10) Patent No.: US 6,264,917 B1 Klaveness Et Al
USOO6264,917B1 (12) United States Patent (10) Patent No.: US 6,264,917 B1 Klaveness et al. (45) Date of Patent: Jul. 24, 2001 (54) TARGETED ULTRASOUND CONTRAST 5,733,572 3/1998 Unger et al.. AGENTS 5,780,010 7/1998 Lanza et al. 5,846,517 12/1998 Unger .................................. 424/9.52 (75) Inventors: Jo Klaveness; Pál Rongved; Dagfinn 5,849,727 12/1998 Porter et al. ......................... 514/156 Lovhaug, all of Oslo (NO) 5,910,300 6/1999 Tournier et al. .................... 424/9.34 FOREIGN PATENT DOCUMENTS (73) Assignee: Nycomed Imaging AS, Oslo (NO) 2 145 SOS 4/1994 (CA). (*) Notice: Subject to any disclaimer, the term of this 19 626 530 1/1998 (DE). patent is extended or adjusted under 35 O 727 225 8/1996 (EP). U.S.C. 154(b) by 0 days. WO91/15244 10/1991 (WO). WO 93/20802 10/1993 (WO). WO 94/07539 4/1994 (WO). (21) Appl. No.: 08/958,993 WO 94/28873 12/1994 (WO). WO 94/28874 12/1994 (WO). (22) Filed: Oct. 28, 1997 WO95/03356 2/1995 (WO). WO95/03357 2/1995 (WO). Related U.S. Application Data WO95/07072 3/1995 (WO). (60) Provisional application No. 60/049.264, filed on Jun. 7, WO95/15118 6/1995 (WO). 1997, provisional application No. 60/049,265, filed on Jun. WO 96/39149 12/1996 (WO). 7, 1997, and provisional application No. 60/049.268, filed WO 96/40277 12/1996 (WO). on Jun. 7, 1997. WO 96/40285 12/1996 (WO). (30) Foreign Application Priority Data WO 96/41647 12/1996 (WO). -
Brain Choline Acetyltransferase Activity in Chronic, Human Users of Cocaine
Molecular Psychiatry (1999) 4, 26–32 1999 Stockton Press All rights reserved 1359–4184/99 $12.00 ORIGINAL RESEARCH ARTICLE Brain choline acetyltransferase activity in chronic, human users of cocaine, methamphetamine, and heroin SJ Kish1, KS Kalasinsky2, Y Furukawa1, M Guttman1, L Ang3,LLi4, V Adams5, G Reiber6, RA Anthony6, W Anderson7, J Smialek4 and L DiStefano1 1Human Neurochemical Pathology Laboratory, Centre for Addiction and Mental Health, Toronto, Canada; 2Division of Forensic Toxicology, Armed Forces Institute of Pathology, Washington, DC, USA; 3Department of Pathology (Neuropathology), Sunnybrook Hospital, Toronto, Canada; 4Department of Pathology, University of Maryland, Baltimore, MD; 5Office of the Hillsborough County Medical Examiner, Tampa, FL; 6Northern California Forensic Pathology, Sacramento, CA; 7Office of the Medical Examiner of District 9, Orlando, FL, USA Cognitive impairment has been reported in some chronic users of psychostimulants, raising the possibility that long-term drug exposure might damage brain neuronal systems, including the cholinergic system, which are responsible for normal cognition. We measured the activity of choline acetyltransferase (ChAT), the marker enzyme for cholinergic neurones, in autopsied brain of chronic users of cocaine, methamphetamine, and, for comparison, heroin. As com- pared with the controls, mean ChAT levels were normal in all cortical and subcortical brain areas examined. However, the two of 12 methamphetamine users, who had the highest brain/blood drug levels at autopsy, had a severe (up to 94%) depletion of ChAT activity in cerebral cortex, striatum, and thalamus. Based on the subjects examined in the present study, our neurochemical data suggest that brain cholinergic neurone damage is unlikely to be a typical feature of chronic use of cocaine, methamphetamine, or heroin, but that exposure to very high doses of methamphetamine could impair, at least acutely, cognitive function requir- ing a normal nucleus basalis cholinergic neuronal system. -
Choline an Essential Nutrient for Public Health
Continuing Education Elevating Awareness and Intake of Choline An Essential Nutrient for Public Health Marie Caudill, PhD, RD Steven Zeisel, MD, PhD Kerry-Ann da Costa, PhD Betsy Hornick, MS, RD Emerging science has revealed that choline plays important Choline is the newest roles in health throughout the life cycle with potentially essential nutrient. serious health consequences associated with inadequate choline intakes. Recent national consumption data indicate that the vast majority of Americans are falling short of recommended intakes. Increased education, including In 2009, the Choline Science Summit was held in Washington, District of Columbia, bringing together recommendations to consume more choline-rich foods, prominent scientists and researchers along with nutrition is needed to improve choline intakes for optimal health. leaders from organizations including the American Nutr Today. 2011;46(5):235–241 College of Obstetricians and Gynecologists, American Dietetic Association, American Society for Nutrition, International Life Sciences Institute, National WIC Association, and US Department of Agriculture (USDA). holine was discovered as a vitamin in 1862, The symposium addressed the latest science on choline but it was more than a century later that it and gathered insights for helping raise awareness Cwas recognized as an essential nutrient. It was and intake of this essential nutrient, especially among officially recognized as an essential nutrient by the vulnerable populations. It included discussions of Institute of Medicine (IOM) in 1998, and an adequate choline’s critical role in human health and development intake (AI) was established based on estimated throughout the life cycle, the role of genetics in dietary intakes and studies reporting liver damage determining choline requirements, and a closer look with lower choline intakes.1 Choline is essential for at the gaps in choline requirements compared with liver and brain function, lipid metabolism, and for actual intakes. -
The Relationship Between Choline Bioavailability from Diet, Intestinal Microbiota Composition, and Its Modulation of Human Diseases
nutrients Review The Relationship between Choline Bioavailability from Diet, Intestinal Microbiota Composition, and Its Modulation of Human Diseases Natalia Arias 1,2,*, Silvia Arboleya 3 , Joseph Allison 2, Aleksandra Kaliszewska 2, Sara G. Higarza 1,4 , Miguel Gueimonde 3 and Jorge L. Arias 1,4 1 Instituto de Neurociencias del Principado de Asturias (INEUROPA), 33003 Oviedo, Asturias, Spain; [email protected] (S.G.H.); [email protected] (J.L.A.) 2 Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, Denmark Hill, London SE5 8AF, UK; [email protected] (J.A.); [email protected] (A.K.) 3 Department of Microbiology and Biochemistry of Dairy Products, Instituto de Productos Lácteos de Asturias (IPLA-CSIC), 33003 Oviedo, Asturias, Spain; [email protected] (S.A.); [email protected] (M.G.) 4 Laboratory of Neuroscience, Department of Psychology, University of Oviedo, Plaza Feijóo, s/n, 33003 Oviedo, Asturias, Spain * Correspondence: [email protected] Received: 14 July 2020; Accepted: 30 July 2020; Published: 5 August 2020 Abstract: Choline is a water-soluble nutrient essential for human life. Gut microbial metabolism of choline results in the production of trimethylamine (TMA), which, upon absorption by the host is converted into trimethylamine-N-oxide (TMAO) in the liver. A high accumulation of both components is related to cardiovascular disease, inflammatory bowel disease, non-alcoholic fatty liver disease, and chronic kidney disease. However, the relationship between the microbiota production of these components and its impact on these diseases still remains unknown. In this review, we will address which microbes contribute to TMA production in the human gut, the extent to which host factors (e.g., the genotype) and diet affect TMA production, and the colonization of these microbes and the reversal of dysbiosis as a therapy for these diseases. -
Marrakesh Agreement Establishing the World Trade Organization
No. 31874 Multilateral Marrakesh Agreement establishing the World Trade Organ ization (with final act, annexes and protocol). Concluded at Marrakesh on 15 April 1994 Authentic texts: English, French and Spanish. Registered by the Director-General of the World Trade Organization, acting on behalf of the Parties, on 1 June 1995. Multilat ral Accord de Marrakech instituant l©Organisation mondiale du commerce (avec acte final, annexes et protocole). Conclu Marrakech le 15 avril 1994 Textes authentiques : anglais, français et espagnol. Enregistré par le Directeur général de l'Organisation mondiale du com merce, agissant au nom des Parties, le 1er juin 1995. Vol. 1867, 1-31874 4_________United Nations — Treaty Series • Nations Unies — Recueil des Traités 1995 Table of contents Table des matières Indice [Volume 1867] FINAL ACT EMBODYING THE RESULTS OF THE URUGUAY ROUND OF MULTILATERAL TRADE NEGOTIATIONS ACTE FINAL REPRENANT LES RESULTATS DES NEGOCIATIONS COMMERCIALES MULTILATERALES DU CYCLE D©URUGUAY ACTA FINAL EN QUE SE INCORPOR N LOS RESULTADOS DE LA RONDA URUGUAY DE NEGOCIACIONES COMERCIALES MULTILATERALES SIGNATURES - SIGNATURES - FIRMAS MINISTERIAL DECISIONS, DECLARATIONS AND UNDERSTANDING DECISIONS, DECLARATIONS ET MEMORANDUM D©ACCORD MINISTERIELS DECISIONES, DECLARACIONES Y ENTEND MIENTO MINISTERIALES MARRAKESH AGREEMENT ESTABLISHING THE WORLD TRADE ORGANIZATION ACCORD DE MARRAKECH INSTITUANT L©ORGANISATION MONDIALE DU COMMERCE ACUERDO DE MARRAKECH POR EL QUE SE ESTABLECE LA ORGANIZACI N MUND1AL DEL COMERCIO ANNEX 1 ANNEXE 1 ANEXO 1 ANNEX -
Suthat Liangpunsakul, M.D. 18 U.S.C
Waiver to Allow Participation in a Food and Drug Administration Advisory Committee DATE: May 12, 2021 TO: Russell Fortney Director, Advisory Committee Oversight and Management Staff Office of the Chief Scientist FROM: Byron Marshall Director, Division of Advisory Committee and Consultant Management Office of Executive Programs Center for Drug Evaluation and Research Name of Advisory Committee Temporary Voting Member: Suthat Liangpunsakul, MD, MPH Committee: Pharmacy Compounding Advisory Committee (PCAC) Meeting date: June 9, 2021 Description of the Particular Matter to Which the Waiver Applies: Suthat Liangpunsakul, MD, MPH, is a temporary voting member of the Pharmacy Compounding Advisory Committee (PCAC). The committee’s function is to provide advice on scientific, technical, and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, and, as required, any other product for which the Food and Drug Administration has regulatory responsibility, and make appropriate recommendations to the Commissioner of Food and Drugs. On June 9th, the committee will discuss bulk drug substances nominated for inclusion on the 503A Bulks List. The nominators of these substances or another interested party will be invited to make a short presentation supporting the nomination. One of the bulk substances to be discussed is choline chloride (uses are for liver diseases (including non-alcoholic fatty liver disease), hepatic steatosis, atherosclerosis, fetal alcohol spectrum disorder, and supplementation in long term total parenteral nutrition). The topic to be discussed during the meeting is a particular matter involving specific parties. Type, Nature, and Magnitude of the Financial Interest: Dr. Liangpunsakul reported that he and his spouse have a financial interest in (b) (6) , a medical technology and device sector mutual fund. -
(12) Patent Application Publication (10) Pub. No.: US 2011/0207718A1 Bird (43) Pub
US 2011 0207718A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2011/0207718A1 Bird (43) Pub. Date: Aug. 25, 2011 (54) COMPOSITIONS AND METHODS FOR A63L/466 (2006.01) TREATING PSYCHATRIC DISORDERS A6II 3/4458 (2006.01) A63/492 (2006.01) (75) Inventor: Philip Bird, Maroochydore (AU) A6IP 25/18 (2006.01) A6IP 25/28 (2006.01) (73) Assignee: GOSFORTH CENTRE A6IP 25/00 (2006.01) (HOLDINGS) PTY LTD., A6IP3/00 (2006.01) Maroochydore (AU) A6IP 25/22 (2006.01) A6IP 25/14 (2006.01) 1-1. A6IP27/02 (2006.01) (22) PCT Filed: Aug. 6, 2009 A6IP 25/08 (2006.01) (86). PCT No.: PCT/AU2O09/OO1OOO (52) U.S. Cl. ......... 514/217: 514/557; 514/454: 514/391; 514/317; 514/359 S371 (c)(1), (2), (4) Date: May 6, 2011 (57) ABSTRACT (30) Foreign Application Priority Data Methods of treating psychiatric disorders are provided which include administration of one or more anti-epileptic agents Aug. 6, 2008 (AU) ................................ 20O8904O16 and, optionally, one or more a psychostimulants. Also pro Aug. 6, 2008 (AU) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20O8904O21 vided are pharmaceutical compositions comprising, in com bination, one or more anti-epileptic agents and one or more Publication Classification psychostimulants. Psychiatric disorders include those asso (51) Int. Cl. ciated with impaired cognitive processing, degenerative dis A6 IK3I/55 (2006.01) orders such as Mild Cognitive Impairment, Parkinson's dis A6 IK3I/I9 (2006.01) ease, dementia, non-compliance with therapeutic regimes A6 IK3I/36 (2006.01) and eating disorders, although without limitation thereto. US 2011/0207718A1 Aug. 25, 2011 COMPOSITIONS AND METHODS FOR the gains in motivation provided by the stimulant will inevi TREATING PSYCHATRC DSORDERS tably wane resulting in the associated return of symptoms.