9. Reference Standards; Standard Solutions; Reagents, Test Solutions
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
Study Protocol and Documented in the Subject Dispensing Log
Protocol Title of trial: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating Three Doses of Subcutaneous Pulsatile GnRH Administered via OmniPod Pump for Ovulation Induction in Female Subjects with Primary Amenorrhea with Hypogonadotropic Hypogonadism NCT number: NCT01976728 Sponsor trial code: 000070 Date: 06 Dec 2017 Gonadorelin Acetate, FE Trial Code: 000070 Date: 06 Dec 2017 999037, FE 999903 E-Protocol Amendment-21975;1.0 No Specified Dosage Form and Strength Supersedes: None Clinical Trial Protocol - Amendment 7 Page 1 of 82 CLINICAL TRIAL PROTOCOL A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating Three Doses of Subcutaneous Pulsatile GnRH Administered via OmniPod Pump for Ovulation Induction in Female Subjects with Primary Amenorrhea with Hypogonadotropic Hypogonadism Trial Code 000070 Consolidated Protocol Incorporating Amendments 1-7 IND Number: 22,278 Investigational Medicinal Product: LutrePulse OmniPod Indication: Primary Hypothalamic Amenorrhea Phase: III Name and Address of Sponsor: Ferring International Pharmascience Center U.S., Inc. 100 Interpace Parkway Parsippany, NJ 07054 P: 973-796-1600 F: 973-796-1660 GCP Statement: This trial will be performed in compliance with GCP. The information in this document is confidential and is proprietary to Ferring International Pharmascience Center U.S. or another company within the Ferring Group. It is understood that information in this document shall not be disclosed to any third party, in any form, without prior written consent -
Penetration of Synthetic Corticosteroids Into Human Aqueous Humour
Eye (1990) 4, 526--530 Penetration of Synthetic Corticosteroids into Human Aqueous Humour C. N. 1. McGHEE,1.3 D. G. WATSON, 3 1. M. MIDGLEY, 3 M. 1. NOBLE, 2 G. N. DUTTON, z A. I. FERNl Glasgow Summary The penetration of prednisolone acetate (1%) and fluorometholone alcohol (0.1%) into human aqueous humour following topical application was determined using the very sensitive and specific technique of Gas Chromatography with Mass Spec trometry (GCMS). Prednisolone acetate afforded peak mean concentrations of 669.9 ng/ml within two hours and levels of 28.6 ng/ml in aqueous humour were detected almost 24 hours post application. The peak aqueous humour level of flu orometholone was S.lng/ml. The results are compared and contrasted with the absorption of dexamethasone alcohol (0.1%), betamethasone sodium phosphate (0.1 %) and prednisolone sodium phosphate (0.5%) into human aqueous humour. Topical corticosteroid preparations have been prednisolone acetate (1.0%) and fluorometh used widely in ophthalmology since the early alone alcohol (0.1 %) (preliminary results) 1960s and over the last 10 years the choice of into the aqueous humour of patients under preparations has become larger and more going elective cataract surgery. varied. Unfortunately, data on the intraocular penetration of these steroids in humans has SUbjects and Methods not paralleled the expansion in the number of Patients who were scheduled to undergo rou available preparations; indeed until recently, tine cataract surgery were recruited to the estimation of intraocular penetration has study and informed consent was obtained in been reliant upon extrapolation of data from all cases (n=88), Patients with corneal disease animal models (see Watson et ai., 1988, for or inflammatory ocular conditions which bibliography). -
Prescribing Support Information GONADORELIN ANALOGUES To
Pending CCG approval Prescribing Support Information GONADORELIN ANALOGUES to achieve feminisation or masculinisation following assessment and diagnosis of Gender Incongruence at the NHS commissioned Cheshire and Merseyside Gender Identity Service AMBER patient retained by specialist Your patient has been identified as being suitable to receive a gonadorelin analogue in accordance with the indications detailed below. They have been started on treatment and have been reviewed to assess the efficacy and adverse effects of the treatment by the specialist team. Prescribing has been retained by the specialist team for the first 6-12 months until stabilisation of the dose and monitoring requirements has been achieved. Triptorelin is the Pan Mersey first line choice. Gonadorelin analogue treatment will continue until gonadectomy. Gonadorelin analogue treatment has been considered as appropriate for prescribing in primary care and the information contained in this document has been provided to support you to prescribe the medicine for your patient in the community. Your patient’s dose is now stable and is detailed in the attached clinic letter. There has been a significant amount of experience in the treatment of gender incongruence over the last 40 years, using several well-established hormonal protocols, and the available evidence demonstrates that, for carefully selected patients, hormone therapy is a safe and effective means of alleviating the potentially debilitating condition of gender dysphoria.1.2 Although these medicines are not licensed for the treatment of gender incongruence, they are medicines with which GPs may be familiar. Your patient will remain under the care of a specialist team within Cheshire and Merseyside Gender Identity Collaborative (CMAGIC) whilst receiving this medicine and will be able to be fast tracked back into the gender service if there are any issues. -
[email protected]
SAFETY DATA SHEET Revision Date 13-Jul-2016 Version 1 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING Product identifier Product Name Pred Forte Other means of identification Product Code FP61 Synonyms Prednisolone Acetate Recommended use of the chemical and restrictions on use Recommended Use Corticosteroid This safety data sheet is written to provide health, safety and environmental information for people handling this formulated product in the workplace. It is not intended to provide information relevant to medicinal use of the product. In this instance patients should consult prescribing information/package insert/product label or consult their pharmacist or physician. For health and safety information for individual ingredients used during manufacturing, refer to the appropriate safety data sheet for each ingredient. Details of the supplier of the safety data sheet Manufacturer ALLERGAN 400 Interpace Parkway, Morris Corporate Center III Parsippany, NJ 07054, USA +1-800-272-5525 E-mail address [email protected] Emergency telephone number Emergency Telephone Call CHEMTREC Day or Night Within USA or Canada: 1-800-424-9300 Outside USA and Canada: +1-703-741-5970 (collect calls accepted) 2. HAZARDS IDENTIFICATION Classification OSHA Regulatory Status This chemical is considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200) Reproductive toxicity Category 2 Effects on or via lactation Yes Label elements Emergency Overview Danger Hazard statements H362 - May cause harm to breast-fed -
Hertfordshire Medicines Management Committee (Hmmc) Nafarelin for Endometriosis Amber Initiation – Recommended for Restricted Use
HERTFORDSHIRE MEDICINES MANAGEMENT COMMITTEE (HMMC) NAFARELIN FOR ENDOMETRIOSIS AMBER INITIATION – RECOMMENDED FOR RESTRICTED USE Name: What it is Indication Date Decision NICE / SMC generic decision status Guidance (trade) last revised Nafarelin A potent agonistic The hormonal December Final NICE NG73 2mg/ml analogue of management of 2020 Nasal Spray gonadotrophin endometriosis, (Synarel®) releasing hormone including pain relief and (GnRH) reduction of endometriotic lesions HMMC recommendation: Amber initiation across Hertfordshire (i.e. suitable for primary care prescribing after specialist initiation) as an option in endometriosis Background Information: Gonadorelin analogues (or gonadotrophin-releasing hormone agonists [GnRHas]) include buserelin, goserelin, leuprorelin, nafarelin and triptorelin. The current HMMC decision recommends triptorelin as Decapeptyl SR® injection as the gonadorelin analogue of choice within licensed indications (which include endometriosis) link to decision. A request was made by ENHT to use nafarelin nasal spray as an alternative to triptorelin intramuscular injection during the COVID-19 pandemic. The hospital would provide initial 1 month supply, then GPs would continue for further 5 months as an alternative to the patient attending for further clinic appointments for administration of triptorelin. Previously at ENHT, triptorelin was the only gonadorelin analogue on formulary for gynaecological indications. At WHHT buserelin nasal spray 150mcg/dose is RED (hospital only) for infertility & endometriosis indications. Nafarelin nasal spray 2mg/ml is licensed for: . The hormonal management of endometriosis, including pain relief and reduction of endometriotic lesions. Use in controlled ovarian stimulation programmes prior to in-vitro fertilisation, under the supervision of an infertility specialist. Use of nafarelin in endometriosis aims to induce chronic pituitary desensitisation, which gives a menopause-like state maintained over many months. -
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. -
Combination of Pretreatments with Acetic Acid and Sodium Methoxide for Efficient Digoxin Preparation from Digitalis Glycosides in Digitalis Lanata Leaves
Pharmacology & Pharmacy, 2016, 7, 200-207 Published Online May 2016 in SciRes. http://www.scirp.org/journal/pp http://dx.doi.org/10.4236/pp.2016.75026 Combination of Pretreatments with Acetic Acid and Sodium Methoxide for Efficient Digoxin Preparation from Digitalis Glycosides in Digitalis lanata Leaves Yasuhiko Higashi*, Yukari Ikeda, Youichi Fujii Department of Analytical Chemistry, Faculty of Pharmaceutical Sciences, Hokuriku University, Kanazawa, Japan Received 21 April 2016; accepted 28 May 2016; published 31 May 2016 Copyright © 2016 by authors and Scientific Research Publishing Inc. This work is licensed under the Creative Commons Attribution International License (CC BY). http://creativecommons.org/licenses/by/4.0/ Abstract We previously developed an HPLC method for determination of lanatoside C, digoxin and α-acetyl- digoxin in digitalis glycosides isolated from Digitalis lanata leaves. Here, we present an improved HPLC-UV method to determine those compounds and deslanoside. We used the improved method to examine the effects of various pretreatments on the amounts of the four compounds isolated from the leaves, with the aim of maximizing the yield of digoxin. Leaves were extracted with 50% methanol, followed by clean-up on a Sep-Pak C18 cartridge prior to HPLC analysis. The amounts of lanatoside C, digoxin and α-acetyldigoxin per 100 mg of the leaves without pretreatment were 115.6, 7.45 and 23.8 μg, respectively (deslanoside was not detected). Pretreatment with acetic ac- id, which activated deglucosylation mediated by digilanidase present in the leaves, increased the amounts of digoxin and α-acetyldigoxin, while lanatoside C and deslanoside were not detected. Pretreatment with sodium methoxide, which hydrolyzed lanatoside C to deslanoside, increased the yields of deslanoside and digoxin, while lanatoside C and α-acetyldigoxin were not detected. -
NINDS Custom Collection II
ACACETIN ACEBUTOLOL HYDROCHLORIDE ACECLIDINE HYDROCHLORIDE ACEMETACIN ACETAMINOPHEN ACETAMINOSALOL ACETANILIDE ACETARSOL ACETAZOLAMIDE ACETOHYDROXAMIC ACID ACETRIAZOIC ACID ACETYL TYROSINE ETHYL ESTER ACETYLCARNITINE ACETYLCHOLINE ACETYLCYSTEINE ACETYLGLUCOSAMINE ACETYLGLUTAMIC ACID ACETYL-L-LEUCINE ACETYLPHENYLALANINE ACETYLSEROTONIN ACETYLTRYPTOPHAN ACEXAMIC ACID ACIVICIN ACLACINOMYCIN A1 ACONITINE ACRIFLAVINIUM HYDROCHLORIDE ACRISORCIN ACTINONIN ACYCLOVIR ADENOSINE PHOSPHATE ADENOSINE ADRENALINE BITARTRATE AESCULIN AJMALINE AKLAVINE HYDROCHLORIDE ALANYL-dl-LEUCINE ALANYL-dl-PHENYLALANINE ALAPROCLATE ALBENDAZOLE ALBUTEROL ALEXIDINE HYDROCHLORIDE ALLANTOIN ALLOPURINOL ALMOTRIPTAN ALOIN ALPRENOLOL ALTRETAMINE ALVERINE CITRATE AMANTADINE HYDROCHLORIDE AMBROXOL HYDROCHLORIDE AMCINONIDE AMIKACIN SULFATE AMILORIDE HYDROCHLORIDE 3-AMINOBENZAMIDE gamma-AMINOBUTYRIC ACID AMINOCAPROIC ACID N- (2-AMINOETHYL)-4-CHLOROBENZAMIDE (RO-16-6491) AMINOGLUTETHIMIDE AMINOHIPPURIC ACID AMINOHYDROXYBUTYRIC ACID AMINOLEVULINIC ACID HYDROCHLORIDE AMINOPHENAZONE 3-AMINOPROPANESULPHONIC ACID AMINOPYRIDINE 9-AMINO-1,2,3,4-TETRAHYDROACRIDINE HYDROCHLORIDE AMINOTHIAZOLE AMIODARONE HYDROCHLORIDE AMIPRILOSE AMITRIPTYLINE HYDROCHLORIDE AMLODIPINE BESYLATE AMODIAQUINE DIHYDROCHLORIDE AMOXEPINE AMOXICILLIN AMPICILLIN SODIUM AMPROLIUM AMRINONE AMYGDALIN ANABASAMINE HYDROCHLORIDE ANABASINE HYDROCHLORIDE ANCITABINE HYDROCHLORIDE ANDROSTERONE SODIUM SULFATE ANIRACETAM ANISINDIONE ANISODAMINE ANISOMYCIN ANTAZOLINE PHOSPHATE ANTHRALIN ANTIMYCIN A (A1 shown) ANTIPYRINE APHYLLIC -
Tanibirumab (CUI C3490677) Add to Cart
5/17/2018 NCI Metathesaurus Contains Exact Match Begins With Name Code Property Relationship Source ALL Advanced Search NCIm Version: 201706 Version 2.8 (using LexEVS 6.5) Home | NCIt Hierarchy | Sources | Help Suggest changes to this concept Tanibirumab (CUI C3490677) Add to Cart Table of Contents Terms & Properties Synonym Details Relationships By Source Terms & Properties Concept Unique Identifier (CUI): C3490677 NCI Thesaurus Code: C102877 (see NCI Thesaurus info) Semantic Type: Immunologic Factor Semantic Type: Amino Acid, Peptide, or Protein Semantic Type: Pharmacologic Substance NCIt Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor tyrosine kinase expressed by endothelial cells, while VEGF is overexpressed in many tumors and is correlated to tumor progression. PDQ Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor -
PHARMACEUTICAL APPENDIX to the TARIFF SCHEDULE 2 Table 1
Harmonized Tariff Schedule of the United States (2020) Revision 19 Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE Harmonized Tariff Schedule of the United States (2020) Revision 19 Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 2 Table 1. This table enumerates products described by International Non-proprietary Names INN which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service CAS registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. -
Prednisolone Also Binds to Transcortin • Other Synthetic GS Only Bind to Albumin
PK/PD considerations for corticosteroids P L Toutain, National Veterinary School, Toulouse, France Wuhan October 2015 1 Anti-inflammatory drugs Corticosteroids NSAIDs 2 Glucocorticoids: main properties • Glucocorticosteroids (GCS) are broad and potent anti- inflammatory drugs. • They are extensively used to mitigate or suppress inflammation associated with a variety of conditions especially joint and respiratory system inflammation. • GCs are not curative: • GCs are only palliative symptomatic treatments and chronic use of GCs can be, in fine , detrimental • GCs possess many other pharmacological properties (not reviewed in this presentation) 3 The cortisol or hydrocortisone 4 Cortisol : An endogenous hormone and a surrogate endpoint of the duration of the GCS effects; it physiology should be understood to use properly GCS 5 Cortisol synthesis • All GCs used in therapeutics are synthetic derivatives of cortisol. • Cortisol (hydrocortisone) is synthesized in the adrenal cortex and it is the main corticosteroid hormone in most species. 6 Steroids synthesis by the adrenal gland Aldosterone Cortisol Androgens Epinephrine (adrenalin) 7 Cortisol ou Hydrocortisone structure – activity relationship Three structural properties are required for a GC activity (i.e. for cortisol to bind to GC receptor) 8 Cortisol (hydrocortisone) • Minimal information on cortisol physiology (secretion, distribution & elimination ) needs to be known to understand the clinical pharmacology of GCS 9 Plasma cortisol • Cortisol levels are very different in domestic species • Pattern of secretion – Circadian rhythm (h) – Pulsatilty (minute) 10 Plasma cortisol level Plasma concentration (ng/mL) 600 500 400 300 Series1 200 100 0 1 2 3 4 5 11 Plasma cortisol levels: circadian rhythm & pulsatility Toutain et al. Domestic.Anim.Endocrinol. -
<<Presentation Title>>
Sihuan Pharmaceutical Holdings Group Ltd. 四環醫藥控股集團有限公司 2013 Interim Results Presentation Stock Code : 0460 Disclaimer The sole purpose of this Presentation (the “Presentation”) is to assist the recipient in deciding whether it wishes to proceed with a further investigation of Sihuan Pharmaceutical Holdings Group Ltd. (the “Company”) and it is not intended to form the basis of any decision to purchase securities, interests or assets in or of the Company. This Presentation does not constitute or contain an offer or invitation or recommendation or solicitation for the sale or purchase of securities, interests or assets in or of the Company and neither this document nor anything contained herein shall form the basis of, or be relied upon in connection with, any contract or commitment whatsoever. Any decision to purchase or subscribe for securities in any offering must be made solely on the basis of the information contained in the prospectus or offering circular issued by the company in connection with such offerings. All the information in this Presentation has been provided by the Company and has not been independently verified. No representation or warranty, express or implied, is or will be made in or in relation to, and no responsibility or liability is or will be accepted by the Company or any of its subsidiaries as to the appropriateness, accuracy, completeness or reliability of, this Presentation or any other written or oral information made available to any interested party or its advisers and any liability therefore is hereby expressly disclaimed. And no reliance should be placed on the accuracy, fairness, completeness or correctness of the information contained in this Presentation.