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Vm - Veterinary Medicines Directorate
Vm - Veterinary Medicines Directorate

... 4.5 Special precautions for use Special precautions for use in animals If more than 10 mg per day is required animals should be monitored particularly carefully. Use of the product in cats with renal dysfunction should be subject to careful risk : benefit assessment by the clinician. Due to the effe ...
Highlights of FDA Activities - College of Pharmacy
Highlights of FDA Activities - College of Pharmacy

... The FDA is advising that rare cases of underactive thyroid have been reported in infants following use of contrast media containing iodine for medical imaging procedures. In all reported cases, infants were either premature or had other serious underlying medical conditions. Available evidence sugge ...
Safety Considerations in Phase 1 Trials - M
Safety Considerations in Phase 1 Trials - M

FINAL Catabasis Pharmaceuticals Presents Positive CAT
FINAL Catabasis Pharmaceuticals Presents Positive CAT

DEPARTMENT OF  HEALTH  AND  HUMAN  SERVICES
DEPARTMENT OF HEALTH AND HUMAN SERVICES

... This is to inform you that the notification you submitted, dated September 27,2004, pursuant to 21 U.S.C. 35Ob(a)(2)(section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act (the Act)) was filed by the Food and Drug Administration (FDA) on September 28,2004. Your notification concerns the subst ...
Medicare JH Local Coverage Article A52018
Medicare JH Local Coverage Article A52018

... Drugs that are usually self-administered by the patient, such as those in pill form, or are used for self-injection, are generally not covered by Part B. However, there are a limited number of self-administered drugs that are covered because the Medicare statute explicitly provides coverage. Example ...
SAFETY OF ORAL IBUPROFEN ñ ANALYSIS OF DATA FROM THE
SAFETY OF ORAL IBUPROFEN ñ ANALYSIS OF DATA FROM THE

... from different sources and also the overall view of the data may use different logic. Individual case reports can provide excellent evidence on attribution in one or more specific patients (6) Among the reported cases, the first one occurred due to medical error connected with the incorrect administ ...
Support for Ohio House Bill 248 Chairwoman Gonzales, Vice Chair
Support for Ohio House Bill 248 Chairwoman Gonzales, Vice Chair

benzydamine hydrochloride - E
benzydamine hydrochloride - E

... tongue, the folds between the teeth, the surfaces under the tongue and to other oral tissues. It is then released over time from these locations into the saliva, rather than being systemically absorbed. Pharmacokinetic conclusions The proposed and reference formulations are oral solutions containing ...
MODEL QUESTION PAPER “Do not write anything on question
MODEL QUESTION PAPER “Do not write anything on question

Vioxx
Vioxx

... of Vioxx and alternative treatments. Any decision about which drug product to take to treat your symptoms should be made in consultation with your physician based on an assessment of your specific treatment needs. 6. What are the likely long-term health effects, if any, of taking this product? The n ...
Slide 1 - edl.io
Slide 1 - edl.io

... A drug is a natural or synthetic substance designed to affect the subject psychologically or physiologically. “Controlled substances” are drugs that are restricted by law. The Controlled Substances Act is a law that was enacted in 1970; it lists illegal drugs, their categories, and penalties for pos ...
Slide 1
Slide 1

... A drug is a natural or synthetic substance designed to affect the subject psychologically or physiologically. “Controlled substances” are drugs that are restricted by law. The Controlled Substances Act is a law that was enacted in 1970; it lists illegal drugs, their categories, and penalties for pos ...
Chapter 7 PPT
Chapter 7 PPT

... A drug is a natural or synthetic substance designed to affect the subject psychologically or physiologically. “Controlled substances” are drugs that are restricted by law. The Controlled Substances Act is a law that was enacted in 1970; it lists illegal drugs, their categories, and penalties for pos ...
The Elements of A Clinical Trial
The Elements of A Clinical Trial

... failure rate is less than 1% per year Any other methods with published data showing that the lowest failure rate is less than 1% per year Barrier method only if used in combination with any of the above acceptable methods.  
Identifying and establishing consensus on the most important safety
Identifying and establishing consensus on the most important safety

... There is an increasing body of evidence that errors in primary care result in harm to patients, particularly in relation to medicines management.1 Most prescribing in the United Kingdom (UK) is undertaken by general practitioners (GPs), and it is here that attention needs to be focused in order to r ...
The Stability of Monoclonal Antibodies (MABs)
The Stability of Monoclonal Antibodies (MABs)

... monospecific antibodies that are the same because they are made by identical immune cells that are all clones of a unique parent cell  Sources of MABs – mouse and human (chimeric) ...
Attachment: Product Information: Vismodegib
Attachment: Product Information: Vismodegib

... Vismodegib is slowly eliminated by a combination of metabolism and excretion of parent drug. Vismodegib is predominant in plasma, with concentrations representing greater than 98% of the total circulating drug-related components. Metabolic pathways of vismodegib in human include oxidation, glucuroni ...
ASHP Guidelines on Pharmacy-Prepared Ophthalmic Products
ASHP Guidelines on Pharmacy-Prepared Ophthalmic Products

... preparation of intravitreal solutions, which resulted in concentrations up to double the intended amounts.3 To ensure adequate stability, uniformity, and sterility, ophthalmic products from licensed manufacturers should be used whenever possible. The following guidelines are intended to assist pharm ...
Phenytoin Sodium 50 mg Film-coated Tablets
Phenytoin Sodium 50 mg Film-coated Tablets

July/August 2008, Number 7
July/August 2008, Number 7

CPS 8 - SCT talk slides 05-16-2016
CPS 8 - SCT talk slides 05-16-2016

... The 5 similar Lucentis-Avastin trials in other countries did not find increased risk of SAE associated with Avastin ...
Clinically Relevant Specifications in Practice
Clinically Relevant Specifications in Practice

ADVANCE IN TREATMENT OF TYPE 2 D.M.
ADVANCE IN TREATMENT OF TYPE 2 D.M.

Presentation
Presentation

... Package Insert Leaflet ...
< 1 ... 96 97 98 99 100 101 102 103 104 ... 193 >

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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