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Orally Disintegrating Tablets
Orally Disintegrating Tablets

Internal Medicine Morning Report
Internal Medicine Morning Report

... challenge and is becoming increasingly more difficult • Multiple drug regimes carry the risk of adverse interactions ...
part b: dossier requirements for miv-1 variations
part b: dossier requirements for miv-1 variations

... 1. Source, history and passage number of the new master cell/seed with documentation of all raw material of human or animal origin used for the entire culture history. 2. Result of all identity testing, including cytogenetic characteristics that could be used to identify the cells. 3. Results of all ...
Update on the Pregnancy and Lactation Labeling Rule (PLLR)
Update on the Pregnancy and Lactation Labeling Rule (PLLR)

... 3 years after the effective date of the final rule ...
Drug Utilization and the Pharmaceutical Pipeline: Correctional
Drug Utilization and the Pharmaceutical Pipeline: Correctional

... • Identify new agents in development and compare them with currently available treatment options by therapeutic class as well as summarize first time generic dates of availability of commonly used agents over the next 24 months. • Assess the impact of new medications and newly approved generic formu ...
Revised: April 2014 AN. 01865/2013 SUMMARY OF PRODUCT
Revised: April 2014 AN. 01865/2013 SUMMARY OF PRODUCT

... Official and local antimicrobial policies should be taken into account when the product is used. Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials. Since enrofloxacin was fir ...
Small Is Beautiful: Issues in Nanomedicine
Small Is Beautiful: Issues in Nanomedicine

...  The prefix “nano” in the SI measurement system denotes 10−9 or one‐billionth. There is no firm consensus over  whether the prefix “nano” is Greek or Latin. While the term “nano” is often linked to the Greek word for “dwarf,”  the ancient Greek word for “dwarf” is actually spelled “nanno” (with a do ...
Natural Medicine LawTM Newsletter
Natural Medicine LawTM Newsletter

... and young adults after using certain introduced by Ortiz and eleven supplements. cosponsors and multisponsors to make it a deceptive trade practice And there have been reports of to sell or offer for sale dietary high school coaches encouraging supplements which are represented or ignoring the use o ...
Click to open - the Population Approach Group in Europe
Click to open - the Population Approach Group in Europe

... approved drugs and patient populations, and second, to apply this knowledge in the decisionmaking process for an internal compound. The integrated analysis included data from 37 phase II– III studies describing 13,474 patients (Figure 1). With this, the efficacy of the internal compound could be put ...
DEVELOPMENT AND IMPLEMENTATION OF PEDIATRIC FORMULARY & DRUG THERAPY
DEVELOPMENT AND IMPLEMENTATION OF PEDIATRIC FORMULARY & DRUG THERAPY

... distribution, metabolism, and elimination of drugs differ not only between pediatric versus adult patients but also among pediatric age groups. The effectiveness and safety of drugs may vary among various age groups and from one drug to another in paediatric versus adult patients. Irrespective of wh ...
Investigational New Drug (IND) Development Programs | Charles
Investigational New Drug (IND) Development Programs | Charles

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, USP 25mg
DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, USP 25mg

... Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, USP 25mg Drug Facts ...
OPKO Health FINAL 13Jan2015 print[1].pptx (Read
OPKO Health FINAL 13Jan2015 print[1].pptx (Read

... “intends,” “estimates,” "potential" and other words of similar meaning, including statements regarding our estimated revenues and financial projections, our ability to achieve high levels of growth, the potential for our products under development, the potential of the 4Kscore™ to reduce prostate bi ...
A REVIEW ON BIOAVAILABILITY AND BIOEQUIVALENCE TRIALS AND ITS NECESSITY 
A REVIEW ON BIOAVAILABILITY AND BIOEQUIVALENCE TRIALS AND ITS NECESSITY 

... standardised as much as possible and acceptable. The studies should  be  normally  performed  on  healthy  adult  volunteers  with  the  aim  to  minimise variability and permit detection of differences between the  study drugs. Subjects may be males or females; however the choice of  gender should  ...
4 FILE COPY L
4 FILE COPY L

... Although stated and restated in numerous ways, FDA’s grounds for declaring oral levothyroxine sodium drug products to be “new drugs” boil down to one, single objection: currently marketed formulations of the drug are not consistent. This point is made by reference to 1) anecdotal reports of patients ...
Day 1 Session 6 Harm Reduction
Day 1 Session 6 Harm Reduction

Kitov Pharmaceuticals
Kitov Pharmaceuticals

AN: 01895/2013 Issued: March 2015 SUMMARY OF PRODUCT
AN: 01895/2013 Issued: March 2015 SUMMARY OF PRODUCT

... In case of accidental ingestion or if you develop symptoms following exposure such as skin rash, you should seek medical advice and show the package leaflet or the label to the physician. Swelling of the face, lips or eyes or difficulty in breathing are more serious symptoms and require urgent medic ...
Oncolys BioPharma and Medigen Biotechnology Enters Strategic
Oncolys BioPharma and Medigen Biotechnology Enters Strategic

... phase-II will share future potential revenues at pre-set Revenue-Sharing-Ratio. Both companies, under Oncolys leadership, will seek a global alliance with a major pharma partner to maximize the value of Telomelysin®. For this agreement with Medigen, Oncolys will receive an up-front payment and poten ...
REM 132
REM 132

... 4. What is the importance of blood flow in relation to clearance of some drugs 5. What is the study state concentration and when is it reached? 6. What is first pass effect? 7. What are prodrugs? 8. What is the importance of therapeutic index, therapeutic window and margin of safety? 9. Which enzyme ...
Public Assessment Report
Public Assessment Report

... sibutramine hydrochloride monohydrate as the active substance. Original products are Reductil 10 and 15 mg hard capsules from Abbott GmbH and Co. KG, Germany, first authorization was granted in Germany in 1999. The original products have been marketed in the Czech Republic since 1999 under the name ...
New TKI toward highly targeted therapies
New TKI toward highly targeted therapies

... Fabbro, D. et al. (2002). Protein kinases as targets for anticancer agents: from inhibitors to useful drugs. Pharmacology & Therapeutics, 93(2-3), 79–98 Grant, S. K. (2009). Therapeutic protein kinase inhibitors. Cellular and Molecular Life Sciences : CMLS, 66(7), Hunter, T. (2007). Review series Tr ...
Food or medicine? - Chinese Medical Center in Europe
Food or medicine? - Chinese Medical Center in Europe

... Red yeast rice capsules: Food or medicine? • All aspects of the product needed to be taken into account when assessing the product, including a consideration of whether or not the dose of any active substance present would result in "appreciable effect" if the product was used as the manufacturer in ...
option
option

ADHD drugs, long
ADHD drugs, long

... and SSRIs and were very similar for 37 of 42 identified symptoms. However, they were not described as dependence for SSRIs. To define similar problems as “dependence” for benzodiazepines and as “withdrawal reactions” for SSRIs is irrational. For patients, the symptoms are just the same; it can be ve ...
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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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