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Catherine Wayte Primary School Drugs, Alcohol and Tobacco Policy
Catherine Wayte Primary School Drugs, Alcohol and Tobacco Policy

...  External visitors e.g. police or school nurse. Drug education is taught as part of a spiral programme of PSHE&C and it builds on concepts that the children already know and understand. It links to work on safety, healthy living and relationships. It focuses on relevant situations and the subsequen ...
Research and Development at Sun Pharma
Research and Development at Sun Pharma

...  At equivalent dosage, AUC 1.6 times higher than existing marketed products  Substantially improved efficacy seen in muscle coordination in animal model  Current global market size : USD 200 million (all existing products are generic)  No. of spastic patients under treatment (US+Europe) : 1.5 mi ...
Within Grey Area: Patents, Pharmaceuticals, and Genomics
Within Grey Area: Patents, Pharmaceuticals, and Genomics

... “purposeful human intervention” to meet the uniqueness standard.5,11 However, the nature of the issue remains more complicated in terms of gene patents, which come into the spotlight with the advent of genomics. Due to the moral issues mentioned earlier, gene patents have become somewhat analogous t ...
U.S. FDA APPROVES ANTIEMETIC AGENT AKYNZEO FOR PREVENTION OF
U.S. FDA APPROVES ANTIEMETIC AGENT AKYNZEO FOR PREVENTION OF

... World’s First Oral Fixed Combination Targeting Two Critical Pathways Involved in CINV Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that Helsinn Healthcare S.A. (Headquarters: Lugano, Switzerland, CEO: Riccardo Braglia, “Helsinn”) has received approval from the U.S ...
Potassium Iodide (KI) - Muskegon County Public Health
Potassium Iodide (KI) - Muskegon County Public Health

... autoimmune thyroiditis should be treated with caution -- especially if dosing extends beyond a few days. What are the possible risks and side effects of taking potassium iodide (KI)? Thyroidal side effects of KI at recommended doses rarely occur in iodine-sufficient populations such as the U.S. As a ...
Alan Goldhammer, PhD
Alan Goldhammer, PhD

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A Clinically-oriented Approach To Teaching Medical

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Vemurafenib film-coated tablets 240 mg product - EMA

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here - The Therapeutics Initiative
here - The Therapeutics Initiative

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... formulation is used, this cannot be done without altering the dose of the other component(s). 3. The time course of action of the components may be different: administering them at the same intervals may be inappropriate. 4. Altered renal or hepatic function of the patient may differently affect the ...
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Antimicrobial Agents (General considerations 4)
Antimicrobial Agents (General considerations 4)

... • Cytochrome P-450 system (CYP3A4, CYP2D6, CYP2C9, CYP1A2, CYP2E1) – Phase II • Conjugation of the parent compound with larger molecules, increasing the polarity • Generally inactivate the parent compound • Glucuronidation, sulfation, acetylation Elimination – Total body clearance (Half life) • Rena ...
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The Patented Medicines (Notice of Compliance) Regulations

... • Innovative pharmaceutical company is typically the first person to discover/develop a drug and/or a new therapeutic indication • Therefore, an NDS is typically filed by an “innovative” pharmaceutical company • Generally, an innovator will have one or more patents pertaining to a new drug • Any cha ...
Introduction to Drugs and Pharmacy
Introduction to Drugs and Pharmacy

... The Federal Food, Drug, and Cosmetic Act,as regulated through Title 21 of the U.S. Code of Federal Regulations, requires a new drug to be approved by the Food and Drug Administration(FDA) before it may be legally introduced in interstate commerce ...
Chapter 4
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PTCB PRACTICE TEST - Pharmacy Technician Educators
PTCB PRACTICE TEST - Pharmacy Technician Educators

... A limited list of drugs found in the pharmacy setting A list of different formulations of drugs Drugs that are extended or sustained – release A compounding principle involving forms of gelatin capsules ...
Questcor Finds Profit for Acthar Drug, at $28,000 a Vial
Questcor Finds Profit for Acthar Drug, at $28,000 a Vial

Outsourcing human tissue research_Outsourcing Pharma
Outsourcing human tissue research_Outsourcing Pharma

Regulatory Considerations for Radiological Software
Regulatory Considerations for Radiological Software

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Ch. 6-Basic Pharmacology - NAC / CNA Certification Spokane
Ch. 6-Basic Pharmacology - NAC / CNA Certification Spokane

... (expected response) usually occurs • All drugs can affect more than one body system, therefore potentially causing side effects and adverse drug reactions – Side Effects: » Unintended reactions to a drug given in a normal dose – Drug Reaction: » Unintended effect on the body from using a legal drug, ...
Drugs - fblocks
Drugs - fblocks

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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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