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Rizatriptan Orifarm tablet ENG PL
Rizatriptan Orifarm tablet ENG PL

... Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. [Product name] is used to treat migraine attacks. Take [Product name] as soon as possible after your migraine headache has started. Do not use it to prevent an attac ...
Strategies for discovering drugs from previously unexplored natural
Strategies for discovering drugs from previously unexplored natural

dosage guide - Veterinary Medicines Directorate
dosage guide - Veterinary Medicines Directorate

Document
Document

... U.S. Customs and Border Protection’s C-TPAT program as either C-TPAT Tier II or Tier III. http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/ucm365626.htm ...
Herbal / Drug Interactions PHARM 512: Clinical Applications of Drug
Herbal / Drug Interactions PHARM 512: Clinical Applications of Drug

... inducer and a p-glycoprotein inducer – Product selection: want standardized extract containing about 0.3% hypericin and 1% hyperforin – Dose: about 300mg TID for treatment – Questions remaining include • How best to use this herbal given that there are drug interaction problems ...
1-Copy of CHAPTER 1
1-Copy of CHAPTER 1

... Where to Measure Concentration? Rarely can the concentration of the drug at the site of action be measured directly; instead the concentration is measured at an alternative and more accessible site, the plasma. ...
Vitex agnus
Vitex agnus

... syndrome (PMS) and especially breast swelling and pain, due to its dopaminergic effect. Although approximately 50% or more of young women suffer from PMS, there is no generally accepted therapy and only a few preparations for that purpose are available on the Swiss market. Therefore the extract prep ...
Slide 1
Slide 1

... approved drug product or conditionally approved drug products currently marketed for human use. • IIG is compile by DDIR – Division of Drug Information Resources. ...
Registration process of API - International Journal of Pharma
Registration process of API - International Journal of Pharma

... Registration procedure for API in US: DMFs have no legal or regulatory basis in the United States; however, they do provide companies a relatively easy and confidential way to provide confidential information about a process without making it available to other commercial companies. The DMF should c ...
pharmacokinetics
pharmacokinetics

Exam 2013 - Qu 37 Student 3
Exam 2013 - Qu 37 Student 3

... through the cell cycle. Egg cells and sperm cells are produced by meiosis. Firstly the amount of DNA must double through semi-conservative replication to ensure the daughter cells have enough chromosomes. Once the DNA has grown and been through checkpoints meiosis can occur, for the separation of ho ...
Guidelines
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... Case study……Artemisinin based FDCs Artesunate + Amodiaquine HCl  Dosing regimen based on weight to age data  Optimised dose ratio i.e. 1 : 3  Rationale: To ensure that patients take both drugs together in the right dose, with a particular attention paid to paediatric needs (dose ratio, age-adapt ...
Colistimethate Sodium 1 Million I.U. Powder for Solution for Injection
Colistimethate Sodium 1 Million I.U. Powder for Solution for Injection

... Based on the review of the data on quality, safety and efficacy, the UK granted a marketing authorisation for the medicinal product Colistimethate Sodium 1 Million I.U. Powder for Solution for Injection (PL 18157/0009) to Beacon Pharmaceuticals Limited on 28th September 2009. This product is a presc ...
- American Heart Journal
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... assessment of QT prolongation. Preclinical safety pharmacologic studies are commonly performed before firstin-human testing to provide an indication of a study drug's likely clinical QT risk. Pharmacologic characterization of the study agent in animals may further reveal circumstances in which incre ...
FY M.Pharm Medicinal Chemistry
FY M.Pharm Medicinal Chemistry

...  Parameters – lipophilicity and related parameters, electronic parameters, steric parameters, other parameters Page 2 of 19 ...
DRUG - ichapps.com
DRUG - ichapps.com

2014 Drugs Not Covered
2014 Drugs Not Covered

... As of Jan. 1, 2014, the excluded medications shown below are not covered on the Express Scripts drug list.* In most cases, if you fill a prescription for one of these drugs after Jan. 1, you will pay the full retail price. ...
ORGANIC VOLATILE IMPURITIES AND THEIR REGULATORY LIMITS ( AS A PART OF PREFORMULATION)
ORGANIC VOLATILE IMPURITIES AND THEIR REGULATORY LIMITS ( AS A PART OF PREFORMULATION)

... solvents when production or purification processes. It is only necessary to test for solvents that are used or produced in the manufacture or purification of drug substances, excipients, or drug product. Although manufacturers may choose to test the drug product, a cumulative method may be used to c ...
教案编写基本格式与要求
教案编写基本格式与要求

... cycle after excretion into the bile are subsequently passed with stool e.g. aluminium hydroxide changes the stool into white colour, ferrous sulfate changes the stool into black and rifampicin into orange red. d) Pulmonary excretion: Drugs that are readily vaporized, such as many inhalation anaesthe ...
Drug Discovery Strategies Today
Drug Discovery Strategies Today

File
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... • Gave marketers of generic drugs ability to file “abbreviated new drug applications” to seek FDA approval • Created to give more incentives to drug manufacturers to offset time and money required to bring new, innovative drug products to market © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. ...
The Nursing Process and Drug Therapy
The Nursing Process and Drug Therapy

... – Enterohepatic circulation ...
2-Understanding Drugs in Children
2-Understanding Drugs in Children

... Fluid volume and dietary fat in the meal appear to be the primary foodrelated factors affecting drug absorption. Meals can alter the absorption rate of sustained-release drugs such as theophylline, making it unpredictable. Iron absorption is facilitated by meat ingestion. Multivitamins containing ir ...
The FDA’s Continuing Incapacity on Livestock Antibiotics *
The FDA’s Continuing Incapacity on Livestock Antibiotics *

... administered through animals’ water, the FDA is asking makers to switch from OTC status to prescription-only status,29 as drugs administered through drinking water are, by law, not subject to veterinary feed directives. The second document published in December 2013 is a proposed rule relaxing the r ...
Lamisil Singeldos cutaneous solution ENG SmPC
Lamisil Singeldos cutaneous solution ENG SmPC

< 1 ... 70 71 72 73 74 75 76 77 78 ... 193 >

Biosimilar

A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product which is a copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original ""innovator"" products, and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval.Unlike the more common small-molecule drugs, biologics generally exhibit high molecular complexity, and may be quite sensitive to changes in manufacturing processes. Follow-on manufacturers do not have access to the originator's molecular clone and original cell bank, nor to the exact fermentation and purification process, nor to the active drug substance. They do have access to the commercialized innovator product.Drug related authorities such as European Medicines Agency (EMA), Food and Drug Administration (FDA), and Health Canada hold their own guidance on requirements for demonstration of the similar nature of two biological products in terms of safety and efficacy. According to them, analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; animal studies (including the assessment of toxicity); and a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product.In case of a monoclonal antibody-containing medicinal product, such as Remsima, extensive physicochemical and biological characterization for it and its reference product Remicade was conducted in order to demonstrate their highly similar properties. Consequently, EMA have granted a marketing authorisation for only a few numbers of biosimilars since 2006 including a monoclonal antibody which is recently approved. Meanwhile, on March 6, 2015, the FDA approved the United States's first biosimilar product, the biosimilar filgrastim Zarxio.
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