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EMA/CHMP/83874/2014
EMA/CHMP/83874/2014

... The primary goal of a pharmacokinetic study in subjects with decreased renal function is to determine if the pharmacokinetics of a drug or an active metabolite is altered to such an extent that specific treatment recommendations are needed in this population. A pharmacokinetic study in subjects with ...
Grapefruit-medication interactions: Forbidden fruit or avoidable
Grapefruit-medication interactions: Forbidden fruit or avoidable

... alone). Conversely, drugs with high bioavailability have a marginally clinically relevant increase in systemic drug concentration. Circumstances of grapefruit consumption Although some pharmacokinetic studies have tested a higher than usual amount of grapefruit juice to determine the maximum effect, ...
Product Information - Therapeutic Goods Administration
Product Information - Therapeutic Goods Administration

oxycodone/naloxone controlled release
oxycodone/naloxone controlled release

... It is uncertain if subjects taking OxyContin® concurrently used an adequate preventative bowel regimen. As such, the clinical benefit of oxycodone/naloxone CR versus Oxycontin® and an adequate preventative bowel regimen has not been established (guidelines generally recommend preventative bowel regi ...
A SURVEY BASED STUDY IN CURRENT SCENARIO OF GENERIC AND... Research Article
A SURVEY BASED STUDY IN CURRENT SCENARIO OF GENERIC AND... Research Article

... medicines allow more patients to be treated with the same amount of money and mobilizes fund to finance other treatment modalities [5]. While manufacturing generic drugs, the drug companies use the same active ingredients and are shown to work the same way in the body, they have the same risks and b ...
Drug Review - Shodhganga
Drug Review - Shodhganga

... Any substance that when taken into the living organism may modify one or more of its function is defined as Drug. W.H.O. has given a more comprehensive definition as “Drug is any substance or product that is used or intended to be used to modify or explore physiological systems or pathological statu ...
MedSafe Paperapplication/msword
MedSafe Paperapplication/msword

... the condition (i.e. self limiting) it should be considered whether any risk is acceptable in the patient population involved. General Cough cold remedies have been widely available in the over the counter arena for many years now, and there is wide acceptance of use of these products in the paediatr ...
Guideline on the investigation of drug interactions - EMA
Guideline on the investigation of drug interactions - EMA

... approach should be well justified and supported by scientific literature. Potential for pharmacokinetic interactions should be investigated both with respect to the effects of other drugs on the investigational drug and the effects of the investigational drug on other medicinal products. As the stud ...
Trends in methylamphetamine availability, use and treatment: 2003
Trends in methylamphetamine availability, use and treatment: 2003

... Australia in 2013, and globally around 5% of the adult population in 2010 (AIHW 2014, UNODC 2012). However, usage patterns continue to change. Changes in the use of methylamphetamine have been one area of increasing concern among health professionals and the Australian community. The harms associate ...


... Prophylaxis can begin 1-2 days before travel to malarial areas. It should be continued daily during travel in the malarial areas and for 4 weeks after the traveller leaves the malarial area. For current advice on geographical resistance patterns and appropriate chemoprophylaxis, current guidelines o ...
nw-qa151-5-how-do-you-switch-between-maois-and-ssris-tcas
nw-qa151-5-how-do-you-switch-between-maois-and-ssris-tcas

... The main reasons for switching antidepressants are an inadequate response to initial therapy despite being used at the right dose for an appropriate duration of time, or the presence of intolerable side effects. When switching between antidepressants there is the potential for interaction between th ...
Quality Control, Screening, Toxicity, and Regulation of Herbal Drugs 2
Quality Control, Screening, Toxicity, and Regulation of Herbal Drugs 2

... Typically, there is no one single herb that is recommended for a given health disorder; and there is no one single health disorder linked with just one single herb. Herbal products often contain a variety of biochemicals found naturally in the plants and many different biochemicals contribute to a p ...
Formulation Development of Chlorpheniramine Maleate Tablet by
Formulation Development of Chlorpheniramine Maleate Tablet by

... had better or nearly equal dissolution and assay. This seems that the direct compression method can be used for manufacturing of low dose drugs like chlorpheniramine maleate tablets. In contrast to wet granulation, direct compression methods are rather simple, save labor time, equipment and space. I ...
EFFECT OF LICORICE AND GRAPEFRUIT JUICE ON PARACETAMOL PHARMACOKINETICS IN
EFFECT OF LICORICE AND GRAPEFRUIT JUICE ON PARACETAMOL PHARMACOKINETICS IN

... Some dietary substances, particularly fruit juices, have been shown to inhibit biochemical processes in the intestine, leading to altered pharmacokinetic and pharmacodynamic outcomes. Cytochrome P450 (CYP450) enzymes constitute the major catalysts of phase I drug biotransformation 1. The CYP3A subfa ...
ANALYSIS  OF COMPARTMENT  MODELS, KINETICS  OF
ANALYSIS OF COMPARTMENT MODELS, KINETICS OF

... per unit time. The symbol is CL and the units are ml/min, L/hr, i.e. volume per time. Another way of looking at Clearance is to consider the drug being eliminated from the body ONLY via the kidneys. [If we were to also assume that the entire drug that reaches the kidneys is removed from the plasma t ...
Can methylphenidate be used for adults with attention deficit
Can methylphenidate be used for adults with attention deficit

... Methylphenidate may reduce the risk of discontinuation when compared with placebo. Long-term studies of side effects in adults are scarce. Safety reviews have indicated an association between the use of methylphenidate and sudden death, however, given the lack of background rates the evidence is inc ...
EA_QA47.7Methylphenidateinadults
EA_QA47.7Methylphenidateinadults

... Methylphenidate may reduce the risk of discontinuation when compared with placebo. Long-term studies of side effects in adults are scarce. Safety reviews have indicated an association between the use of methylphenidate and sudden death, however, given the lack of background rates the evidence is inc ...
INHIBITORY EFFECTS OF ACTIVE CONSTITUENTS AND EXTRACTS OF ANDROGRAPHIS
INHIBITORY EFFECTS OF ACTIVE CONSTITUENTS AND EXTRACTS OF ANDROGRAPHIS

... Herbal-drug interactions are generally characterized as either pharmacodynamic, via the site of action at the drug-receptor level, or pharmacokinetic, involving absorption, distribution, metabolism and excretion [1]. The most commonly documented interactions are pharmacokinetic interactions secondar ...
Guidelines for the regulation of herbal medicines in the South
Guidelines for the regulation of herbal medicines in the South

... In most cases, severe diseases refer to a life-threatening illness or those diseases in which delayed treatment will lead to deterioration of the disease state or loss of capability to cure them. For example, severe cardiovascular, gastrointestinal, endocrine, haematological diseases, and immune dis ...
Controlling drug delivery chapter 1 Over view
Controlling drug delivery chapter 1 Over view

... and intraperitoneal administration. Usually aqueous solutions are used for intravenous delivery, but it is also possible that the dosage form contains a dispersed phase (solid or liquid), provided the dispersed particles are small enough (e.g. smaller than 100–150 nm) to avoid embolism. For other ro ...
EA_QA68.6_ErythromycinandStatins
EA_QA68.6_ErythromycinandStatins

... Simvastatin is metabolised by cytochrome P450 3A4 [8, 11]. Potent inhibitors of cytochrome P450 3A4 such as erythromycin and some other macrolides increase plasma levels of simvastatin and significantly increasing the risk of myopathy and rhabdomyolysis during concomitant treatment. In an interactio ...
Enabling Pharmacists To Respond To The Health Needs Of
Enabling Pharmacists To Respond To The Health Needs Of

... property of curing, preventing, treating, or mitigating diseases, or that is used for that purpose. Discussion: These definitions “Drug” and “Medicine” come forward from the 1937 Act, unchanged. Contemporary professional usage makes little distinction between the two. However, lay usage ascribes a n ...
proposed rule
proposed rule

... Purpose of the Regulatory Action The Food and Drug Administration (FDA) is proposing to amend its labeling regulations at 21 CFR 201.100, 201.306, 201.310, 606.121, 606.122, 610.60, and 610.61 for human prescription drugs and biological products, and blood and blood components intended for transfusi ...
As we know, there are two main areas of pharmacology, they are
As we know, there are two main areas of pharmacology, they are

... ions, glucose and amino acids. The action of the sodium-potassium pump is an example of active transport, you’ll discuss it in 24 chapter, in drugs used heart failure. As to facilitated diffusion, it is a process of passive transport without needing energy. In facilitated diffusion, the solutes move ...
Assessment of model BE study
Assessment of model BE study

...  FDA - Guidance for Industry: “Bioavailability and Bioequivalence Studies for Orally Administered Drug Products – General Considerations” (Oct. ...
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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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