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WHO Drug Information - World Health Organization
WHO Drug Information - World Health Organization

... presence of 345 participants from over 90 agencies. In addition to the event, participants were invited to celebrate thirty years of ICDRAs. Both developed and developing country officials joined in confirming the value and impact of this forum to national, regional and international medicines regul ...
Sketchy knowledge skeptical attitude towards generic and branded
Sketchy knowledge skeptical attitude towards generic and branded

... version of a drug is manufactured by other companies for sale, after expiry of patent protecting innovator drug.(1) Generic Drug is defined as “A drug product that should have same active ingredient, strength, and dosage form, route of administration, quality, performance and intended use as the bra ...
Vitamin B15 A Review and Update
Vitamin B15 A Review and Update

... they noted that it is without historical precedence, according to Dr. Kendall, Research Director at DaVinci Labs. If DMG were marketed as the pure, unadulterated, identifiable chemical substance, the "food additive" designation would not apply and the product could be freely sold in interstate comme ...
Objectives for Pharmacists - New York State Council of Health
Objectives for Pharmacists - New York State Council of Health

CDAS|Safety Pharmacology
CDAS|Safety Pharmacology

... Database (SED). Our SED contains profile data for more than 2,300 compounds including marketed, failed, withdrawn, and OTC drugs as well as reference agents, agrochemicals and natural product compounds which have been screened through 65 ligand binding and enzyme assays. The result is a highly enric ...
FORMULATION AND CHARACTERIZATION OF DRUG IN ADHESIVE TRANSDERMAL PATCHES Research Article
FORMULATION AND CHARACTERIZATION OF DRUG IN ADHESIVE TRANSDERMAL PATCHES Research Article

... physical stability and integrity of the patches at high humid conditions. In the present study the moisture absorption capacities of the films were determined in the following manner. The patches were placed in dessicator containing saturated solution of aluminum chloride, keeping the humidity insid ...
Interactions of Grapefruit Juice with Drugs
Interactions of Grapefruit Juice with Drugs

Amitriptyline Hydrochloride 10mg/5ml Oral Solution PL 29831/0460
Amitriptyline Hydrochloride 10mg/5ml Oral Solution PL 29831/0460

EA_QA312.3_levothyroxineseakelp
EA_QA312.3_levothyroxineseakelp

... thyroid disorders, mainly hypothyroidism and hyperthyroidism. This effect has been attributed to the iodine contained in these products (1, 2, 4-7). Several case reports about this association have been published (1, 4). Mechanism of Interaction The normal daily iodine requirement ranges from 100 to ...
Call for data for the 81st meeting of JECFA to be held on 17 to 26 November 2015
Call for data for the 81st meeting of JECFA to be held on 17 to 26 November 2015

... the mid-1950s by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) to assess chemical additives in food on an international basis. The first meeting was held in 1956 in response to recommendations made at an FAO/WHO Conference on Food Additives ...
Perspective Herb–Drug Interactions: Challenges and Opportunities
Perspective Herb–Drug Interactions: Challenges and Opportunities

... associate and dissociate rapidly from the enzyme is termed timedependent inhibition (TDI). Mechanism-based inhibition (MBI), often observed as TDI, is characterized by irreversible or quasi-irreversible noncovalent binding of a reactive metabolite to the enzyme (Grimm et al., 2009). Such binding can ...
Modern Methods in Drug Discovery WS06/07
Modern Methods in Drug Discovery WS06/07

... present SNPs in it allow two approaches: 1. Finding new targets (either on the genome, the mRNA, or the protein level) 2. pharmacogenomic methods will lead to personalized medicine (which drug and at what dosage), esp. for long term application of certain drugs (hypertension, analgesics, anti-psycho ...
Revised: November 2014 AN: 00887/2014 SUMMARY OF
Revised: November 2014 AN: 00887/2014 SUMMARY OF

... Direct contact with the skin should be avoided because of sensitisation, contact dermatitis and possible hypersensitivity reactions. ...
P h a rmaceutical  industry  is  short ... drugs. Whereas in past decades about 50-60 new
P h a rmaceutical industry is short ... drugs. Whereas in past decades about 50-60 new

... drugs. Whereas in past decades about 50-60 new drugs (new chemical entities, NCEs) were approved every year and introduced into therapy, this number declined significantly in the last few years, reaching its historical low in the year 2000 with 27 NCE’s, 2001 with 24 NCEs, and 2002 with only 18 NCEs ...
Open Access Could Transform Drug Discovery
Open Access Could Transform Drug Discovery

Read Document - MotherToBaby
Read Document - MotherToBaby

... • Retinoid: Natural or synthetic derivative of vitamin A • Retinoic Acid: A synthetic form of vitamin A –Isotretinoin (Accutane®) is a retinoic acid. ...
Abuse of OTC Drugs
Abuse of OTC Drugs

product monograph
product monograph

... NEULASTA with 5-FU or other anti-metabolites has not been evaluated in humans, although it has been studied and shown to potentiate myelosuppression in animal models (see TOXICOLOGY). The safety and efficacy of NEULASTA have not been evaluated in patients receiving radiation therapy. Carcinogenesis ...
QSAR_AND_DRUG_DESIGN_new
QSAR_AND_DRUG_DESIGN_new

AusPAR: Normal Human Immunoglobulin
AusPAR: Normal Human Immunoglobulin

Interactions of herbs and food products with drugs
Interactions of herbs and food products with drugs

... properties and herbal medicines are popular worldwide. Since, all herbal medicines are mixtures of more than one active ingredient, such combinations of many substances obviously increase the likelihood of interactions taking place. Although herbal medicines have been used as remedies for number of ...
2014 Report on prescription drug costs
2014 Report on prescription drug costs

The anti-tubercular drug delamanid as a potential oral treatment for
The anti-tubercular drug delamanid as a potential oral treatment for

... A cost-effective way to find a new treatment for a disease is to repurpose existing clinically approved drugs that are used to treat other diseases. Patterson, Wyllie et al. now report that a drug called delamanid, which was recently approved for the treatment of tuberculosis, can cure visceral leis ...
Dimethyl MEA - Mattilsynet
Dimethyl MEA - Mattilsynet

A mathematical model for maximizing the value of phase 3
A mathematical model for maximizing the value of phase 3

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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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