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National Essential Anaesthesia Drugs List (NEADL)
National Essential Anaesthesia Drugs List (NEADL)

... and to make contingency plans for shortages. The AAGBI would be pleased to see such exercises submitted as abstracts at WSM London meetings and at its Annual Congresses so that experiences might be shared. In 2014, the AAGBI joined the American Society of Anesthesiologists (ASA) and other National S ...
Impurities: Residual Solvents ICH: Q3C
Impurities: Residual Solvents ICH: Q3C

Importance of in -vitro in -vivo studies in pharmaceutical
Importance of in -vitro in -vivo studies in pharmaceutical

Integrative systems control approach for reactivating Kaposi’s
Integrative systems control approach for reactivating Kaposi’s

... feedback control optimization system, they found a mixture of effectors to activate the nuclear factor kappa B (NFkB) pathway in 293T cells. Wong et al. was able to use the feedback control platform to find likely optimal combinations in less than 30 test cases out of a possible one million combinatio ...
Appendix S5.
Appendix S5.

... in the form of the pure S-enantiomer in Australia, New Zealand and Europe as an anthelminthic for veterinary use under the trade name of Zolvix®. NC S CF 3 NH O F 3C ...
Plants: The Potential for Extracting Protein, Medicines, and Other
Plants: The Potential for Extracting Protein, Medicines, and Other

... In addition to the prescription drugs, the sale of herbal teas in the United States is estimated at least $200 million annually and the sale of over-thecounter (OTC) drugs obtained from plants is probably over $1 billion. For example, about one-half of the OTC laxative preparations sold annually in ...
1/12
1/12

... development of biomarkers. Due to genetic causes of variability among individuals, genotyping and gene expression analysis are indeed key elements of the emergence of personalised medicine. However, genomic technologies have limitations (functional significance of genetic variants, false negatives, ...
kinetics of iv bolus: urine data
kinetics of iv bolus: urine data

Click here for the PowerPoint presentation
Click here for the PowerPoint presentation

Presentation
Presentation

... •Inhibition/induction of polymorphic CYP increase/decrease exposure to therapeutic drugs in EMs (and PMs for induction). Current UF for human variability in toxicokinetics (3.16) would not cater for these interactions •Results variable ; detailed analysis to classify interaction according to constan ...
CMS Issues Final Rule to Implement Medicaid Drug Pricing and
CMS Issues Final Rule to Implement Medicaid Drug Pricing and

... Sales Versus Rebates: As set forth above, rebates and other price concessions paid to Medicaid, SPAPs, SCHIP, TRRx, and Medicare Part D are excluded from AMP, according to CMS, because these programs do not purchase drugs directly but instead reimburse for drugs purchased from entities in the distri ...
Pepto – Bismol (Gastro-Bismol) (Bismuth Salicylate) PL 00129/0141
Pepto – Bismol (Gastro-Bismol) (Bismuth Salicylate) PL 00129/0141

... toxins and bile acids (c) animal studies demonstrated an inhibition of secretion and stimulation of absorption thereby reducing fluid in the intestine and (d) human studies demonstrated a decreasing GI motility or transit time. This is a bibliographic abridged application for an oral suspension cont ...
DEVELOPMENT AND EVALUATION OF CONTROLLED RELEASE
DEVELOPMENT AND EVALUATION OF CONTROLLED RELEASE

... Many of the dermal vehicles contain chemical enhancers and solvents to modify drug permeation through skin. But use of these chemical enhancers may be harmful, especially in chronic application, as many of them are irritants. Therefore, it is desirable to develop a topical vehicle system that does n ...
Gastro-Bismol
Gastro-Bismol

... toxins and bile acids (c) animal studies demonstrated an inhibition of secretion and stimulation of absorption thereby reducing fluid in the intestine and (d) human studies demonstrated a decreasing GI motility or transit time. This is a bibliographic abridged application for an oral suspension cont ...
Moore - AL.com
Moore - AL.com

... Case 2:15-cv-00529-SLB Document 1 Filed 03/30/15 Page 10 of 38 ...
in the elderly
in the elderly

... • There is no satisfactory doctor-patient relationship in time or in depth because of the crowded outpatient services. • The elderly often take OTCs (over-the-counter drugs) about which the doctor is not informed. ...
Strict Liability in the Manufacture of
Strict Liability in the Manufacture of

... chemical compound. When a drug is ingested, the response of an individual patient is difficult to predict. Every effect and each adverse reaction is unique. Frequently, the response to the chemical is more dependant on the individual's physiology than on product design. Therefore, a safely designed ...
Me-too drugs: is there a problem
Me-too drugs: is there a problem

... incentives for innovation. This seems improbable, since me-too drugs offer relatively little therapeutic benefit over pioneering drugs. This is, however, ultimately an empirical question. One perspective on this question is the following: if consumers highly value me-too drugs over pioneers, they s ...
THE ROLE OF LIPIDS IN DRUG ABSORPTION THROUGH THE GIT
THE ROLE OF LIPIDS IN DRUG ABSORPTION THROUGH THE GIT

... without using organic solvents and avoids at the same time the use of solubilisers potentially having side effects (Crauste-Manciet et al., 1998). Compared to other particulate carriers such as liposomes and polymeric nanoparticles, o/w emulsions possess several advantages: they integrate accepted e ...
Full Text - International Journal Of Pharmacology And
Full Text - International Journal Of Pharmacology And

... Result and Discussion The purpose of degradation studies is to investigate those changes, to get a shelf life for the drug product and to recommend storage conditions, which will be applicable to all future batches of the tested drug product manufactured and packaged under similar circumstances [13] ...
PFN 2003 - AIFA Agenzia Italiana del Farmaco
PFN 2003 - AIFA Agenzia Italiana del Farmaco

... instrument (DDD-PDD); DDDs or PDDs cannot make a class “homogeneous” or “unhomogeneous”; as usual the technical instrument is a dependant variable in relation to the scientific choice of the homogeneity criterion, for which the CUF has referred to the IV ATC level in a flexible way. • It is evident ...
(PSD) March 2016 PBAC Meeting
(PSD) March 2016 PBAC Meeting

Access to Quality Medicines: Rajasthan Model
Access to Quality Medicines: Rajasthan Model

... for All”, good quality healthcare is a basic fundamental right of people and should be made available to all. In all advances in medical sciences, medicines have remained the core in the healthcare and would continue to be the core; thereby it implies that access to essential medicines is also a bas ...
Apotex Launches First Generic Plavix®
Apotex Launches First Generic Plavix®

... Apotex Launches First Generic Plavix® Consumers Have Immediate Access to an Affordable Version of this Important Product Weston, Fl (August 8, 2006) - Apotex Corp. announced that it has today launched clopidogrel bisulfate 75 mg tablets. Clopidogrel is the generic equivalent of Sanofi's Plavix®, whi ...
Investor FactBook - FY 2014 results27-February
Investor FactBook - FY 2014 results27-February

... As for our commercial strategy, we have our own presence covering specialist physicians, payers and patient groups, in North America, Europe and major emerging markets. In all areas, we continue to learn from best-in-class companies outside the biopharma industry in areas such as innovation, custome ...
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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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