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Enalapril Maleate
Enalapril Maleate

... Concentration (PEC) / Predicted No Effect Concentration (PNEC) has not been determined. No information is available concerning the biodegradability, however enalapril is not predicted to bioaccumulate in aquatic organisms. Predicted Environmental Concentration (PEC) The PEC is based on the following ...
Vet Info 1 Noromectin PLUS
Vet Info 1 Noromectin PLUS

... Transitory discomfort has been observed in some cattle following subcutaneous administration. Soft-tissue swelling at the injection site has also been observed. These reactions have disappeared without treatment. Divide doses greater than 10 mL between two injection sites to reduce occasional discom ...
a review on dosage regimen - Indian Journal of Pharmaceutical
a review on dosage regimen - Indian Journal of Pharmaceutical

... The main objective of individualization is aimed at optimizing the dosage regimen. An inadequate therapeutic response calls for a higher dosage whereas drug related toxicity calls for a reduction in dosage. Thus in order to aid individualization, a drug must be made available in dosage forms of diff ...
Preparation of PCR Products for DNA Sequencing
Preparation of PCR Products for DNA Sequencing

... suboptimal PCR were revealed by DNA sequencing and autoradiographic detection (n >10; data not shown). Artifacts ranged from 52–68 bp in length. A strong interfering signal was observed across all four lanes at a position corresponding to a product length of 52 nucleotide (nt) on the sequencing gels ...
SHARED CARE GUIDELINES ON MELATONIN FOR SLEEP DISORDERS/DIFFICULTIES IN CHILDREN (NELFT)
SHARED CARE GUIDELINES ON MELATONIN FOR SLEEP DISORDERS/DIFFICULTIES IN CHILDREN (NELFT)

... are headaches, dizziness, nausea, and drowsiness. Increased seizure activity has been reported in patients with epilepsy but there is also anecdotal evidence that seizure activity improves as a result of improved sleep. Much of the clinical trial data with melatonin does not report an increase in se ...
Drugs that may exacerbate psoriasis
Drugs that may exacerbate psoriasis

The over-the-counter pharmaceutical market - policy and practice
The over-the-counter pharmaceutical market - policy and practice

... equilibrium. When a new medicinal compound is first licensed for use by the public in the UK, and depending on the evidence of safety and efficacy in the premarketed period, it is classified as POM. After two years this classification defaults to P unless there is a specific application to retain th ...
Drug Absorption
Drug Absorption

... • Water-insoluble drugs, such as spironolactone (diuretic drug) and griseofulvin (antifungal drug) are better absorbed when taken directly after a meal. • However, absorption of these water-insoluble drugs, and also carbamazepine (antiparasitic drug) and nitrofurantoin (antibiotic) is improved when ...
Psychopharmacology Update
Psychopharmacology Update

... -Drug 0.25 mg -Drug 2 mg -Drug 4 mg -Placebo ...
innovative self-injection solutions
innovative self-injection solutions

this PDF file
this PDF file

Read more - Jal pharma
Read more - Jal pharma

... Herbal – Herbal Results of clinical studies with an extract of manufacturer A are not automatically valid for the extract of manufacturer B ...
Yolande Knight serotonin syndrome presentation BASH meeting
Yolande Knight serotonin syndrome presentation BASH meeting

Physicians` attitude towards voluntary reporting of adverse drug
Physicians` attitude towards voluntary reporting of adverse drug

... advantage of covering a large number of patients and a wide range of drugs. Taking all these in consideration, any new marketed drug and those that are already well established, should be closely monitored in order to detect any new, unexpected or serious ADRs. In order to clarify some terms used in ...
Drug Class 5-HT3 Receptor Antagonists (Anti
Drug Class 5-HT3 Receptor Antagonists (Anti

... interval, diuretics which can induce electrolyte disturbances and cumulative high dose anthracycline therapy. ...
pdf version here - Health Sciences Authority
pdf version here - Health Sciences Authority

... and effectiveness of medicines ordered, as they are not evaluated by the authorities. Harmful chemicals or ingredients may be added and such medications can be addictive or harmful to your health. iii. Risk of Poor Quality Products Unapproved medicines may not have been manufactured under quality as ...
Dosage Form Design: Pharmaceutical and Formulation
Dosage Form Design: Pharmaceutical and Formulation

... administered conveniently as such. Also, the liquid nature of undecylenic acid certainly does not hinder but rather enhances its use topically in the treatment of fungus infections of the skin. However, for the most part, pharmacists prefer solid materials in formulation work because they can easily ...
Interchangeability and study design
Interchangeability and study design

... Analytical assay sensitivity ...
Budget Impact Assessment Form
Budget Impact Assessment Form

... should be used, where possible. If Alberta-specific data is not available, other sources may be used if justification is provided, sources are adequately referenced and ...
Pharmacokinetic/Pharmacodynamic Parameters: Rationale
Pharmacokinetic/Pharmacodynamic Parameters: Rationale

... duration of time that the levels exceeded the MIC. The 24hour AUC/MIC ratio for the two regimens would be the same. Such study designs are rarely used in human clinical trials but are easily performed with animal infection models. Several investigators have used multiple dosage regimens in animal in ...
Adverse Drug Reaction–Related Hospitalizations Among
Adverse Drug Reaction–Related Hospitalizations Among

... hospitalization (Table 1). Among the five drug classesvii most commonly associated with ADR-related hospitalization, glucocorticoids had the next-highest linkage rate, at 82.4%, while opioids and NSAIDs had rates of 78.1% and 62.6%, respectively, among patients with a related hospitalization. The li ...
Therapeutic Drug Monitoring (TDM)
Therapeutic Drug Monitoring (TDM)

... dosage must, therefore, be adjusted on the basis of the plasma lithium concentration 6–12 hours post-dose. The plasma lithium should then be monitored 3–4 monthly to ensure that dosage is still optimal.3 As indicated above a very important general point in TDM is the time the sample is taken in rela ...
Sample pages 1 PDF
Sample pages 1 PDF

... Various chemicals have been used as permeation enhancers. These include surfactants, bile salts, fatty acids and non-surfactants (such as cyclodextrins, chitosan and Azones) [6,17,18,19–21]. Mucoadhesive polymers [22–24] and penetration enhancers used for oral mucosal delivery have been extensively ...
Role of Dosimetric Scaling and Species
Role of Dosimetric Scaling and Species

Dissolution Testing of Poorly Soluble Compounds
Dissolution Testing of Poorly Soluble Compounds

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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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