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Acaisia - Acacia Pharma
Acaisia - Acacia Pharma

... – Down-regulation of cytokines TNFα, IL-1, IL-6 and IFNγ • Rectify abnormalities and stimulate appetite ...
Product Development Issues of Powders for Injection
Product Development Issues of Powders for Injection

... primary pack allows the formulation of drugs that are thermolabile or unstable in aqueous solution. However, lyophilization normally yields an amorphous or partially amorphous product, which leads to solid-state instability (3). A more-stable crystalline stage can be obtained by crystallization in a ...
BASS & ULLMAN, E G.
BASS & ULLMAN, E G.

... Schedule IV “be supplied or dispensed for use by individuals As a signatory to pursuant to medical prescription only. . . .“ the Convention, if the WHO recommendations are adopted by the CND, the United States would be obligated to reclassify ephedrine as a prescription only substance, an action whi ...
Feline Arthritis Treatments
Feline Arthritis Treatments

... behavior changes. It can be expensive for long term use but it is a good option for an acute short term flare up of pain when needed. With long term use it may also cause constipation. c. NON-STEROIDAL ANTI-INFLAMMATORY DRUGS OR NSAIDS. Here is a link from an Australian website on the NSAID MELOXICA ...
Slides - Clinical Trial Results
Slides - Clinical Trial Results

... ● Pediatric drug trials are technically challenging, yet wellpowered safety and efficacy trials are critically important for child health ● Results of negative studies provide important information ● Issues such as lack of a liquid formulation, failure to incorporate PK into dosing, lack of equipois ...
Continuing evolution of the drug discovery process in
Continuing evolution of the drug discovery process in

Benefits of Listing a Patent
Benefits of Listing a Patent

... Partner, Frommer Lawrence & Haug LLP Editor, FDA Lawyers Blog ...
Routes of Administration
Routes of Administration

...  A drug’s effects may be longer and more intense if liver and/or kidney are not functioning up to par. ...
Application of Induced Infringement Law in Pharmaceutical Patent
Application of Induced Infringement Law in Pharmaceutical Patent

... 378. The Federal Circuit affirmed the ruling on induced infringement, noting they “have long held that the sale of a product specifically labeled for use in a patented method constitutes inducement to infringe that patent . . . .” Eli Lilly & Co., 435 Fed. Appx. at 926. In AstraZeneca LP v. Apotex, ...
9th July 2014 meeting minutes - Gateshead Health NHS Foundation
9th July 2014 meeting minutes - Gateshead Health NHS Foundation

... TA313 – Psoriatic arthritis – ustekinumab – not approved by NICE and not on the formulary. TA315 – Canagliflozin in combination for type 2 diabetes - – approved as an option by NICE. Formulary will reflect this. CG180 – Advanced breast cancer (update): diagnosis & treatment – all drugs currently on ...
Diapositive 1 - Moodle Lille 2
Diapositive 1 - Moodle Lille 2

... • Avoid the use of Alemtuzumab before & after the MS-indication approval ? Total dose ...
Development of Pharmaceutical Products from Medicinal Plants
Development of Pharmaceutical Products from Medicinal Plants

... bases to explain its properties and to develop clinical studies to demonstrated the scientifically probed useful of this extract. ...
Interactions with systemic antifungal agents
Interactions with systemic antifungal agents

Creatinine Clearance
Creatinine Clearance

Pharmacy Update on Dose Optimization Program
Pharmacy Update on Dose Optimization Program

1 Topical Corticosteroids in Children
1 Topical Corticosteroids in Children

... amount recommended for adults and a child between one and four years of age will require one-third of the adult amount. Children over four years of age may be treated as adults.5 In addition to addressing the amount of medication to be applied, specific information should be provided on the frequenc ...
Antibiotic Use in Agriculture: Background and Legislation CRS Report for Congress
Antibiotic Use in Agriculture: Background and Legislation CRS Report for Congress

... Use of Antibiotics in Agriculture8 Types of Use Antibiotics are used in food-producing animals for three major reasons, according to HHS’s Centers for Disease Control and Prevention (CDC).9 First, they are used in high doses for short periods of time to treat sick animals. Second, they are used—also ...
1294-Dodoo-_b
1294-Dodoo-_b

... • (a) take all appropriate measures to encourage patients, doctors, pharmacists and other healthcare professionals to report suspected adverse reactions to the national competent authority; for these tasks, organizations representing consumers, patients and healthcare professionals may be involved a ...
The Patented Medicines (Notice of Compliance) Regulations
The Patented Medicines (Notice of Compliance) Regulations

... • Innovative pharmaceutical company is typically the first person to discover/develop a drug and/or a new therapeutic indication • Therefore, an NDS is typically filed by an “innovative” pharmaceutical company • Generally, an innovator will have one or more patents pertaining to a new drug ...
Revised: September 2012 AN: 00730/2012 SUMMARY OF
Revised: September 2012 AN: 00730/2012 SUMMARY OF

... nervous, the product may be given in divided doses at 15 minute intervals. ii) Transport of boars: 0.5 ml/20 kg (1 mg/kg) The animals should not be brought together within the first half hour following injection because they are still likely to be aggressive; they should be left alone in a quiet env ...
EU Regulations for Clinical Studies in Pediatric Patients
EU Regulations for Clinical Studies in Pediatric Patients

... it is a pediatric orphan drug or to another type of extension of exclusivity obtained for having provided “significant clinical benefit in comparison with existing therapies.”14 (In the EU, a drug or biologic is eligible for orphan designation if it “is intended for the diagnosis, prevention, or tre ...
100908 Gen Pharm (pt 2).
100908 Gen Pharm (pt 2).

... • Albumen is one of the chief proteins in the blood available for binding with drugs. • When a pt. Is malnourished, albumen is low. • What significance does this have re; drug therapy? ...
Mid-semester test 2008 - The University of Auckland
Mid-semester test 2008 - The University of Auckland

... Complete your name and ID information (as per your ID card) and version code (i.e. 00000001) on the SCANTRON MCQ form as instructed using a pencil (no entry is required for the STREAM box). Answer all questions; you have 45 minutes to complete the paper of 40 questions. There is only one correct ans ...
SUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS

Panacur horse and cattle dewormer suspension
Panacur horse and cattle dewormer suspension

... Do not use in horses intended for food. Cattle must not be slaughtered for human consumption within 8 days following treatment. Do not use at 10 mg/kg in dairy cattle. Dose rate of 10 mg/kg is for beef cattle only. Dose rate of 10 mg/kg in dairy cattle could result in violative residues in milk. A w ...
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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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