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Drug Deletions - Texas Department of State Health Services
Drug Deletions - Texas Department of State Health Services

... docusate sodium with casanthranol ipecac ...
DOCTORAL THESIS
DOCTORAL THESIS

... consumption of antidiabetic drugs (5,6). Thus, CVD prevention should be considered in all patients with one or more cardiovascular risk factors. Currently there are several risk scores for prediction of CVD. Developing a general applicable risk score is difficult because of confounders associated wi ...
National Medicines Information Centre MEDICATION SAFETY
National Medicines Information Centre MEDICATION SAFETY

... Improving safety in the prescribing, dispensing and administration of medicines is a priority for health services throughout the world and many countries have put in place strategies to deal with this issue.19 Many of these provide good practice recommendations in areas that are known to be error pr ...
July 2013 Monitoring International Trends
July 2013 Monitoring International Trends

... prevention of bleeding episodes in haemophilia B in patients over the age of 16. It is a purified protein made with recombinant DNA technology. For prophylaxis it is administered intravenously twice a week. The drug's efficacy was assessed in 73 male patients aged from 12 to 65. Reported side effect ...
Developing Integrated Clinical Trials Systems: The ClinAccess Experience
Developing Integrated Clinical Trials Systems: The ClinAccess Experience

... validation, and audit trails. One or more users are identified to CLiNAcCESS as Database Administrators (DBA). To protect the integrity of the data, only the DBA's have access to a subsystem of CLiNAcCESS which is used to: create study libraries, define new studies to the system, manage existing stu ...
Joint Therapies Laura Werner, DVM, MS, DACVS From the moment
Joint Therapies Laura Werner, DVM, MS, DACVS From the moment

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Document

... Nomenclature Drugs are categorized under broad ...
in vivo
in vivo

... -Glucagon-Like peptide-1(GRP-1) induces pancreatic secretion of insulin for type II diabetic patients -Type II diabetes market expect to reach US$20.5 billion by 2012 - 10/2002 resolved formulation problems due to degradation of product; slowed phase I/II trials; now last 3 months -Phase I/II result ...
Herbal Remedies: Drug-Herb Interactions
Herbal Remedies: Drug-Herb Interactions

... were developed from plants. So, indeed, herbs can be potent products. Herbs can affect body functions; therefore, when herbs are taken concurrently with drugs, interactions are possible. Botanical medications have increased in popularity. In the United States, botanical products are now a $1.5 billi ...
FDA Continues to Study BPA
FDA Continues to Study BPA

... epoxy resins. These hard, clear plastics are often used in containers that store food and beverages, such as some water bottles. The resins are also used to protect foods from microbial and other contamination by coating the inside of metal products, such as some food cans. Research has shown that p ...
Amberlite IRP69 -- Technical Data Sheet
Amberlite IRP69 -- Technical Data Sheet

... exchange resins. Proper design of process equipment to prevent rapid buildup of pressure is necessary if use of an oxidising agent such as nitric acid is contemplated. Before using strong oxidising agents in contact with ion exchange resins, consult sources knowledgeable in the handling of these mat ...
optimising drug and device together for novel
optimising drug and device together for novel

... and drugs with poor lung tissue penetration (Ciclosporin A). Compared with individual actuations from a pMDI or DPI, nebulisers generate a large amount of fine aerosol which enables the drug to be more evenly distributed to the large surface area of the lungs (best illustrated by “wetting” a tennis ...
Primer for Investigational New Drug
Primer for Investigational New Drug

... Scenario 1: Yes. An IND is needed for this study because: a) it involves the use of a product for the purpose of mitigating the effects of a disease, and b) the results may be used in support of a new indication for labeling and/or marketing. Scenario 2: Yes. An IND is needed for this study because: ...
THE CROSSROADS OF PHARMACEUTICAL
THE CROSSROADS OF PHARMACEUTICAL

... The annual global market for pharmaceuticals is estimated at $500 billion. The World Health Organization (“WHO”) reported in 2006 that the counterfeit drug industry worldwide had revenues of over $40 billion. The same report also referenced that counterfeit drug sales will likely reach $75 billion g ...
From the Editor Nimesulide Adverse Reactions Reported
From the Editor Nimesulide Adverse Reactions Reported

FREEDOM OF INFORMATION SUMMARY REVOLUTION
FREEDOM OF INFORMATION SUMMARY REVOLUTION

... Data on human food safety, pertaining to consumption of drug residues in food were not required for approval of this supplemental NADA. This drug is labeled for use in dogs and cats which are non-food producing animals. Human warnings are provided on the product label as follows: “May be irritating ...
pharmaceuticals: restrictions in use and availability
pharmaceuticals: restrictions in use and availability

... chemical names; the effective date on which the regulation came into force; a summary of regulatory measures taken by governments; brief explanatory comments where necessary; and legal and bibliographical references. While the information cannot be regarded as exhaustive, either in terms of products ...
Drugs - World of Teaching
Drugs - World of Teaching

Bacon Wrapped Presentation 2014 FDB
Bacon Wrapped Presentation 2014 FDB

... metabolize these drugs more quickly or more slowly than average. These variations can help the physician identify how a patient's metabolism works. If the test reveals that a patient metabolize drugs rapidly or slowly, the doctor may consider adjusting your drug dosages or switching to a non 2D6 or ...
Extrapolating from animal studies to the efficacy in humans of a
Extrapolating from animal studies to the efficacy in humans of a

... In pretreatment therapy against nerve agents, careful dose determination is even more crucial than in antidotal therapy, since excessive doses may lead to adverse effects or performance decrements. The common method of comparing dose per body weight, still used in some studies, may lead to erroneous ...
DEPARTMENT  OF  HEALTH  AND  HUMAN ... Food  and  Drug  Administratiqn
DEPARTMENT OF HEALTH AND HUMAN ... Food and Drug Administratiqn

... the study. The Yale investigators su mitted protocols to FDA forreview. ...
R D ESEARCH AND EVELOPMENT
R D ESEARCH AND EVELOPMENT

... raise ethical problems. For the time being, the descriptors obtained at a very early stage are mainly those predicting the pharmacokinetics of drugs (via their metabolism genetically determined by cytochromes P450 and their transport). The intermediate situation in which the descriptor is identified ...
HiQ VERISEQ Nitrogen
HiQ VERISEQ Nitrogen

... internationally harmonised specifications from an approved supplier. Such pharmaceutical grade products are delivered in accordance with applicable pharmacopoeia monographs. To be approved by the United States (US) Food and Drug Administration (FDA) as a manufacturer of active pharmaceutical ingredi ...
Comments Submitted by Immel Resources LLC
Comments Submitted by Immel Resources LLC

... cleaning or adding materials to the batch is problematic – because an error in those operations would be difficult to detect (you can only test for what you know to test for). The error may not be discovered prior to distribution, and may result in patient injury and product recall. We have had nume ...
Clinically relevant safety issues associated with St. John`s wort
Clinically relevant safety issues associated with St. John`s wort

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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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