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IPEC EUROPE `HOW-TO׳ DOCUMENT Guidelines of 19 March
IPEC EUROPE `HOW-TO׳ DOCUMENT Guidelines of 19 March

... insights provided in this guide will help users of excipients to proactively address this new GMP compliance assessment. Bearing in mind the EU Guidelines (OJ 2015/C 95/02) have not introduced new or higher requirements for either Users or Suppliers of excipients with Quality Management Systems comp ...
AusPAR: Metformin HCI / Linagliptin
AusPAR: Metformin HCI / Linagliptin

PPIs May Reduce Effectiveness Of Clopidogrel (PLAVIX®)
PPIs May Reduce Effectiveness Of Clopidogrel (PLAVIX®)

Comparing Inhaled Corticosteroids
Comparing Inhaled Corticosteroids

article
article

... herbal products in Palestine. In our study, the majority of pharmacists reported receiving inquires about herbal medicine by the general public. Herbal products are commonly used and dispensed in the neighboring countries as well [17-20] . Almost all pharmacists in the United Arab Emirates (UAE) and ...
RISK PROFILE of acetanilide
RISK PROFILE of acetanilide

... for total exposure assessments. Using painkillers such as ibuprofen, aspirin and paracetamol in pregnancy may harm development of the sex organs in unborn boys, warn Kristensen and coworkers (12). The condition known as cryptorchidism is a risk factor for reduced fertility and increased risk of test ...
PROPOSAL FOR THE INCLUSION OF RISPERIDONE FOR THE
PROPOSAL FOR THE INCLUSION OF RISPERIDONE FOR THE

... 5. Formulation proposed for inclusion: (for Adult Model List only) Risperidone: Oral tablets containing 0.25 mg, 0.5 mg, 1 mg, 2mg, 3 mg, 4 mg, and 6 mg 6. International availability including manufacturers and trade names: Risperidone gained US FDA-approval as a “new molecular entity” under the tra ...
Word version of Full Report
Word version of Full Report

... practitioners. Further information on these arrangements is available in the General Statement for Topical Anti-Glaucoma Drugs Prescribed by Authorised Optometrists as Pharmaceutical Benefits in the March 2009 PBS Schedule. In March 2015, the PBAC considered a submission by Optometry Australia to re ...
Daptomycin Use in United States Children*s Hospitals
Daptomycin Use in United States Children*s Hospitals

... • MRSA & VRE infections are associated with M& M, and costs across all age groups. ...
50 years of oral lipid-based formulations
50 years of oral lipid-based formulations

... ultimately colloidal structures with small particle sizes are required to diffuse across the unstirred water layer (UWL) and present drug to the intestinal absorptive surface. Formulations that are pre-dispersed to form small emulsion droplets (microemulsions, nanoemulsions), or that spontaneously e ...
Melatonin - Sweetwater OB GYN
Melatonin - Sweetwater OB GYN

... Melatonin is a natural hormone nutrient that is synthesized from the amino acid tryptophan by the pineal gland in the back of the brain. Melatonin also occurs in small amounts in a variety of foods. In the body, melatonin appears to regulate sleep/wake cycles, support normal immune function, and pro ...
Phenylpropanolamine and Hemorrhagic Stroke in the Hemorrhagic
Phenylpropanolamine and Hemorrhagic Stroke in the Hemorrhagic

... cases were asked about their PPA use prior to their catastrophic event, whereas controls were asked about their use before a day chosen in the last 7 days. Thus, cases are likely to have over-reported PPA use compared to controls. The HSP investigators concluded a lack of recall bias because they re ...
Nervous System Cells
Nervous System Cells

... • The neurotransmitter may be reabsorbed by the axon that released it (reuptake), diffuse away, be removed from the body as a waste product (metabolized), or remain in the synapse. © 2011 Cengage Learning. All Rights Reserved. May not be copied, scanned, or duplicated, in whole or in part, except fo ...
Medication and Smoking Cessation
Medication and Smoking Cessation

pharmaceutical packaging: current trends and future
pharmaceutical packaging: current trends and future

Advice to The Expert Advisory Committee on drugs on: LSD
Advice to The Expert Advisory Committee on drugs on: LSD

... suggestive of a revival in interest in the drug in the last few years. After a longterm downward trend dating back to the 1990s, both the number and the quantity of seizures increased from 2003 but might be declining again7. LSD retail prices (adjusted for inflation) have been slightly declining sin ...
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... All ADRs even if ...
Extract from the Clinical Evaluation Report for tenofovir disoproxil
Extract from the Clinical Evaluation Report for tenofovir disoproxil

... After a screening period of up to 28 days, visits occurred every four weeks during which study drug was dispensed and compliance counselling was given. At each visit, a medical history was taken and rapid testing for HIV-1 antibodies was performed. Subjects who were HBV negative at baseline were off ...
Needle Free Injection Systems - The Pharma Innovation Journal
Needle Free Injection Systems - The Pharma Innovation Journal

... gets into the bloodstream and provokes the body to create antibodies that are carried throughout the entire body. In the United States, children may get over 13 vaccine injections by the age of 16. Unfortunately, there are a variety of problems associated with the hypodermic needles used for these i ...
Ulipristal acetate - Therapeutic Goods Administration
Ulipristal acetate - Therapeutic Goods Administration

... The initially proposed assay limits at expiry were not acceptable. According to Therapeutic Goods Order No 78 (TGO78), the lower limit must be no less than 92.5%. The lower limit for assay was revised and this was acceptable. In relation to the shelf life, data was included to support an unopened sh ...
Osmotic-Controlled Release Oral Delivery System
Osmotic-Controlled Release Oral Delivery System

Public Assessment Report Scientific discussion Tracydal 20 mg, film
Public Assessment Report Scientific discussion Tracydal 20 mg, film

PART II - Veterinary Medicines Directorate
PART II - Veterinary Medicines Directorate

... faeces/diarrhea, faecal occult blood, loss of appetite and lethargy have been reported. These adverse reactions occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal. If adve ...
PRODUCT MONOGRAPH
PRODUCT MONOGRAPH

... activity during oral rinsing which is maintained between rinsings. Microbiologic sampling of plaque has shown a general reduction of both aerobic and anaerobic bacterial counts ranging from 54-97% through six months’ clinical use. Rinsing with PERICHLOR inhibits the buildup and maturation of plaque ...
The role of pharmacoepidemiological studies in the market
The role of pharmacoepidemiological studies in the market

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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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