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Parenteral - Pharmacy Fun
Parenteral - Pharmacy Fun

... A variety of agents are used in sterile products to adjust tonicity. Most common are simple electrolytes such as sodium chloride or other sodium salts and non-electrolytes such as glycerin and lactose. Tonicity adjusters are usually the last ingredient added to the formulation after other ingredient ...
EU Clinical Trials Register Glossary | Search for Clinical Trials
EU Clinical Trials Register Glossary | Search for Clinical Trials

... active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled in a different way from the authorised form, or when used for an unauthorised indication, or when used to gain further information abou ...
The OtisMed plea agreement
The OtisMed plea agreement

... its subsidiaries that:  Falls within the scope of the Information to which OtisMed is pleading guilty;  Was a subject of the investigation regarding the “Custom Fit Total Knee Replacement with OtisKnee” (hereinafter “OtisKnee”) medical devices; or  Was otherwise known to the U.S. Attorney for the ...
Antipsychotics in the Pipeline
Antipsychotics in the Pipeline

... Division of Neuropharmacological Drug Products Food and Drug Administration ...
renal impairment studies in early development services
renal impairment studies in early development services

... should be discussed as recommendations about dose adjustments should be based on comparisons to patients with renal functions that is typical for the usual patient population intended to treat with the IMP. As noted in the Executive Summary, it is recommended to have renal impairment trials conducte ...
- Covenant University
- Covenant University

... Pharmacies permeate and interconnect various actions developed in different sectors within the complex process of the use of drugs in a hospital. The health care systems have to be reorganized to systems that function in a cross-border fashion. This demands a significant redesign of business process ...
FDA Warning Letter to SR Burzynski Manufacturing Facility 2016
FDA Warning Letter to SR Burzynski Manufacturing Facility 2016

pharmacokinetics-5
pharmacokinetics-5

... • Highly polar drugs will dissolve in GIT but they will fail to be absorbed through the lipid cell membrane of the gut wall while nonpolar drugs will be poorly soluble in the GIT instead they will dissolve in the fat globules leading to poor surface contact with cell membranes resulting in poor abso ...
DDD107498: A novel clinical candidate for malaria
DDD107498: A novel clinical candidate for malaria

... Half of the world’s population, 3.2 billion people, is at risk of malaria 198 millions cases in 2013 584 000 deaths, mostly among children under five (437 000) 90% of all malaria deaths occur in Africa $12 billion lost GDP Consumes 40% of public health spending There are four types of human Plasmodi ...
スライド タイトルなし
スライド タイトルなし

... Public Relations ...
Patch development with new drugs versus generic development
Patch development with new drugs versus generic development

... Government records show that at least four children have died and six have been hospitalized since 1997 after being exposed to just one type of transdermal drug, the fentanyl patch, which also sickened the Maine boy. Another three were exposed to the drug, but the outcome wasn’t recorded, according ...
Glossary - CHRISTUS Health
Glossary - CHRISTUS Health

... Cohort - A group of subjects initially identified as having one or more characteristics in common who are followed over time. In social science research, this term may refer to any group of persons who are born at about the same time and share common historical or cultural experiences. Collaborator ...
Cyclodextrins and Cyclodextrin Derivatives as
Cyclodextrins and Cyclodextrin Derivatives as

File
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... 3. Microorganism: antibiotics 4. Synthetic and chemical substance: as sodium bicarbonate. 5. Drugs produced by genetic engineering : Human insulin, human growth hormone ...
impurities in new veterinary medicinal products (revision)
impurities in new veterinary medicinal products (revision)

... concern, including drug class effects and clinical experience. For example, qualification can be especially important when there is evidence that such degradation products in certain new veterinary medicinal products or therapeutic classes have previously been associated with adverse reactions in an ...
COSMIC-HF AHA Data Presentation Press Release
COSMIC-HF AHA Data Presentation Press Release

... indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Furth ...
Discovery Labs Presents Surfaxin and Aerosurf
Discovery Labs Presents Surfaxin and Aerosurf

... those contained in these forward-looking statements are the risk that Discovery may not profitably develop and market its products, the risk that financial market conditions may change, the risk that Discovery will not be able to raise additional capital or enter into additional collaboration agreem ...
Prescription_Medications
Prescription_Medications

... for use. Additionally, the doses used in Qsymia are much lower than the usual doses of phentermine and topiramate when prescribed separately. Qsymia is available in three doses: a starting dose, a recommended dose, and a higher dose. After 1 year of treatment with Qsymia, 62 percent of patients who ...
Provision or distribution of growth hormone for
Provision or distribution of growth hormone for

... 26% reporting peripheral edema (3% for placebo).21 Because of these high rates of adverse effects,22 nonsustained improvements in quality of life23,24 and anabolic effects,24,25 and the drug’s high cost, even the treatment of AIDS wasting syndrome with GH has little support.23,26,27 The doses used i ...
Investigational Drugs
Investigational Drugs

... approved commercial IRB, prior to starting the research. Research that requires an IND will be reviewed as follows: • A project that meets the criteria for Expedited Review will be evaluated by the IRB Chair or his/her designee. This individual will confirm that the IND number and information provid ...
1361 FEBl32003 '03  MWR24  P1:52
1361 FEBl32003 '03 MWR24 P1:52

... The interpretation of the term “ingestion” to mean enteral administration into the stomach and gastrointestinal tract is also supported by the language of the statutory sections immediately preceding and following section 35O(c)( l)(B)(ii). Section 35O(c)( l)(B)(i) states that the vitamin must be in ...
Pharmacogenetics: Clinical Implications
Pharmacogenetics: Clinical Implications

... Patients with low or absent TPMT activity are at an increased risk of developing severe, life-threatening myelotoxicity from IMURAN if conventional doses are given. Physicians may consider alternative therapies for patients who have low or absent TPMT activity (homozygous for nonfunctional alleles). ...
DRUG INTERACTIONS
DRUG INTERACTIONS

... GFJ increases bioavailability for felodipine by 200%, nifedipine 57% and verapamil by 36%. Inhibition of P-glycoprotein increases bioavailability of drugs. GFJ : enzyme and P-glycoprotein inhibitor ...
English - emcdda
English - emcdda

... control the substance) and reports of seizures in 14 European countries. A risk-assessment report will be submitted to the European Commission and Council of the EU after the meeting, on the basis of which the Council may decide to subject the drug to control measures across the EU. 4-MA belongs to ...
Introduction Drug interference Validity of control and
Introduction Drug interference Validity of control and

... Drug tolerance can be improved by implementing an acid dissociation step, using in solution phase kinetics or by switching assay format or platform ...
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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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