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Phenylpropanolamine (PPA) Advisory
Phenylpropanolamine (PPA) Advisory

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PowerPoint 簡報
PowerPoint 簡報

... fraction drug →↑risk for adverse effects from highly proteinbound drugs Ex.: Anticoagulant - warfarin, ...
Drugs may be indirect to pathogenesis
Drugs may be indirect to pathogenesis

... No consensus has been reached ...
Safety issues of drug use - WHO archives
Safety issues of drug use - WHO archives

r MAR 03 2004 Memorandum
r MAR 03 2004 Memorandum

... This is to inform you that the notification you submittedpursuantto 21 U.S.C. 350b(a)(2)(section413(a)(2)of the FederalFood, Drug, and dosmetic Act (the Act)) was filed by the Food and Drug Administration (FDA) on October27,2003. Your notification concernsthe substance“Piracetam”also known as 2-oxo- ...
plants as a source of new medicines
plants as a source of new medicines

... new research programme; define the target; synthesise and screen the activity of potential leads; select the optimal few and further define their pharmacological and safety profile. Optimistically, one or two candidates make it into development. If clinical efficacy and safety are demonstrated to ac ...
506861726d2032303038
506861726d2032303038

... Metabolism: How a drug is broken down for excretion. Products of breakdown are called metabolites. Metabolites are rendered small, inactive or less active before excretion occurs. Metabolism usually occurs in the liver, however can occur in the kidneys, lungs, blood plasma, or intestinal mucosa. ...
Deutsche Bank 36th Annual Health Care Conference
Deutsche Bank 36th Annual Health Care Conference

... Deutsche Bank 36th Annual Health Care Conference ...
The Benefits of Bacillus-derived Hyaluronic Acid
The Benefits of Bacillus-derived Hyaluronic Acid

... mix of polymers without the ability to distinguish between high and low molecular weight. From the outset, it was essential that a technique was found to modify all elements of filtration including flow, process times and temperature, to enable a highly viscous polymer such as HA to be moved through ...
THE DISTURBANCES OF ABSORPTION
THE DISTURBANCES OF ABSORPTION

... Bioavailability of a drug According to the European Medicines Evaluation Agency (EMEA): bioavailability means the rate and extent (amount) to which the active substance or active moiety is absorbed from a pharmaceutical form, and becomes available at the site of action (in the general circulation). ...
thiazide diuretics - Christchurch Drug Information Service
thiazide diuretics - Christchurch Drug Information Service

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Pharmacology - New Caney ISD
Pharmacology - New Caney ISD

... •Evaluates safety or harmful effects of a drug to ensure the drug provides effective treatment ...
Questions for Term Test #2
Questions for Term Test #2

... 3. Which one of the following statements best describes drugs classified as partial receptor agonists? a. Partial agonists are prodrugs that split into full agonists in the body b. Full agonists are more potent than partial agonists c. Partial agonists have less efficacy than full agonists d. Partia ...
PRESENTATION FOR IMMEDIATE RELEASE
PRESENTATION FOR IMMEDIATE RELEASE

... Dr Allen Bain – pharmacologist who co-developed a block buster antiarrhythmia drug now being commercialized by Merck Dr Aldar Bourinbaiar – specialist in viral disease, discovered an AIDS treatment used globally Dr Galyna Kutsyna – a researcher and specialist in AIDS and viral disease Dr Manuel Carp ...
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AMERICAN COLLEGE of

... conditions for which there are no associated symptoms with which a consumer can assess the drug’s efficacy. The risk of sub-therapeutic dosage or sub-optimal therapeutic endpoint is increased in a drug which requires monitoring to assess its effectiveness. High-risk consumers and those with establis ...
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Bio-Path Holdings to Initiate Development of Liposomal Bcl

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Irbesartan/Hydrochlorothiazide
Irbesartan/Hydrochlorothiazide

... Environmental risk assessment Environmental risk assessment is not required. This product is intended to substitute for other identical products on the market. The approval of this product does not result in an increase of the total quantity of irbesartan and hydrochlorothiazide released into the en ...
CPP-109 Clinical Trial Data to be Presented at the American Society
CPP-109 Clinical Trial Data to be Presented at the American Society

... FDA has recognized that CPP-109 is intended for the treatment of a serious or life-threatening condition for which there is no effective treatment and which demonstrates the potential to address an unmet medical need. Catalyst also expects to evaluate CPP-109 for the treatment of other addictions an ...
BIOAVAILABILITY AND BIOEQUIVALENCE STUDIES
BIOAVAILABILITY AND BIOEQUIVALENCE STUDIES

ICCVAM Test Method Evaluation Report: Appendix B2 December 2007 § 314.50
ICCVAM Test Method Evaluation Report: Appendix B2 December 2007 § 314.50

... proved applications are required to be submitted in the form and contain the information, as appropriate for the par­ ticular submission, required under this section. Three copies of the application are required: An archival copy, a re­ view copy, and a field copy. An applica­ tion for a new chemica ...
Prescribing in Pregnancy_2011
Prescribing in Pregnancy_2011

... • 60% of mothers gave a history of taking Contergan • Drug was withdrawn between 1962-1963 • 10,000 affected children were born world-wide • 40% of victims died before their first birthday ...
Classification of research and development activities
Classification of research and development activities

... introduced on the market, they must be tested systematically on human volunteers to ensure that they are both safe and effective. These clinical trials are divided into four standard phases, three of which take place before permission to manufacture is accorded. For the purposes of international com ...
DEPARTMENT OF  HEALTH  AND  HWAN  SE&VICES
DEPARTMENT OF HEALTH AND HWAN SE&VICES

... becom e effective ...
Traditional Chinese Medicine And New Drug Development
Traditional Chinese Medicine And New Drug Development

... – Part of Asian American (especially Chinese American) culture – The Chinese railroad workers used TCM for routine medical needs since the early 1850s (CPRR) ...
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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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