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pharm tech 2016-2017 class 2 ch 7 thru 13
pharm tech 2016-2017 class 2 ch 7 thru 13

... and transmission of electronic devices O Greatly increases punishment for unauthorized release of PHI O Important provisions: O Strengthens electronic security of PHI O Allows online access to PHI by patient O Allows online submission of PHI forms ...
thalidomide - Universidade Nova de Lisboa
thalidomide - Universidade Nova de Lisboa

... finally stop distribution within Germany. Other countries followed and, by March of 1962, the drug was banned in most countries where it was previously sold. ...
a randomised, controlled, open-label, phase ii
a randomised, controlled, open-label, phase ii

... Goals of PRACTECAL  Identify a new regimen(s) for M/XDR-TB that is radically shorter, tolerable, effective and feasible to scale up through a clinical trial compliant with international standards for Good Clinical Practice (ICH-GCP); ...
PUBLIC ASSESSMENT REPORT of the Medicines Evaluation Board
PUBLIC ASSESSMENT REPORT of the Medicines Evaluation Board

... A CEP has been submitted; therefore no details on the manufacturing process have been included. Quality control of drug substance The drug substance specification is in line with the Ph.Eur. monograph on cefixime and with the additional requirements for the highest unknown impurity and residual solv ...
Sponsor vs. Investigator
Sponsor vs. Investigator

Dr. Alex Nivorozhkin, Chief Operating Officer Amorsa Therapeutics
Dr. Alex Nivorozhkin, Chief Operating Officer Amorsa Therapeutics

... Unlocking Ketamine’s Potential “The medical community is missing out on one of the best pain drugs there is.” Director, Defense Center for Integrative Pain Management • Ketamine was approved as an anesthetic in 1970 • Recent studies have shown ketamine’s analgesic and antidepressant effects but wit ...
Merck Global Security
Merck Global Security

... Robert D. Moore, Executive Director; Global Security Group Merck & Co., Inc. ...
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Part II Summary of Product Characteristics

... Do not use in animals known to be hypersensitive to the active substance. ...
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... Once ANDA is approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. A generic drug product is the one that is comparable to an innovator drug product in dosage form, strength, route of administration, qual ...
See Jefferies presentation here
See Jefferies presentation here

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or S-warfarin
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HESS 525 - The Citadel
HESS 525 - The Citadel

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1 Thus , Knowledge of physicochemical properties

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Phase I Issues for Novel TB Drugs

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Emerging Drug Trends - Northland Coalition
Emerging Drug Trends - Northland Coalition

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... product processed in a single process or series of processes so that it could be expected to be homogenous. In the case of continuous manufacture, the batch must correspond to a defined fraction of the production, characterized by its intended homogeneity. It may sometimes be necessary to divide a b ...
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Notes on the Design of Bioequivalence Study: Dolutegravir
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PLEXION® Cleanser - Mission Pharmacal
PLEXION® Cleanser - Mission Pharmacal

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Decisions taken in the 59th Meeting of the Genetic Engineering

... DCGI representative informed that the formal market authorization for import and use of the drug in India is under issue. It was also clarified that DCGI approval is initially only for a period of two years during which the applicant has to generate adequate data on safety and efficacy of the produc ...
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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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