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3. ACHIEVEment of policy goals
3. ACHIEVEment of policy goals

... considering them in the context of the broader policy and market environment in which they operate, and investigating their role in contributing to Canada’s achievements in meeting a range of objectives relating to the pharmaceutical policy. The federal government regulates prices of patented pharma ...
BAOJ Pharmaceutical Sciences
BAOJ Pharmaceutical Sciences

... the gastrointestinal contents, poor membrane permeability, or presystemic metabolism. Compounds can have poor membrane permeation due to large-molecular weight, as is the case with proteins and other macromolecules, or insufficient lipophilicity to partition into biological membranes, as with many h ...
Introduction - Harvard DASH
Introduction - Harvard DASH

... During the New Drug Application (NDA) approval process, FDA conducts a form of costbenefit analysis based on data from trials provided by the drug’s sponsor. The agency may approve a drug with higher risks so long as it shows promising clinical results, and conversely it may require less proof of e ...
Rethinking and Restructuring the FDA Drug Approval Process in
Rethinking and Restructuring the FDA Drug Approval Process in

... mandate, critics contend that the FDA cannot rely on private drug manufacturers to selfregulate their products. Merck’s decision is a mere indicator of the substantial problems that cripple the effectiveness of FDA pharmaceutical regulatory approvals, particularly in regard to the management and use ...
Pelagia Research Library Hydroxypropyl methylcellulose
Pelagia Research Library Hydroxypropyl methylcellulose

... retention, and as a binder. HPMC imparts little or no flavor to food. The historical record in the literature is not entirely clear on when HPMC was first introduced into food or any other commercial use. However, references point to a US patent on its preparation having been issued in 1960 to the D ...
Pharmacokinetics
Pharmacokinetics

... of systemic infections that could complicate treatment. Moreover, toxicities or overdose by the oral route may be overcome with antidotes such as activated charcoal. On the other hand, the pathways involved in drug absorption are the most complicated, and the drug is exposed to harsh gastrointestina ...
Pharmaceutical Marketing: A Comparison of Different
Pharmaceutical Marketing: A Comparison of Different

... The other sections are as follows: Important things that you should know about your medicine – this section outlines the most important things that the patient needs to know about the drug. What the drug is and what it is used for – this describes what the drug is and a description of what it is use ...
Modeling and comparison of dissolution profiles
Modeling and comparison of dissolution profiles

... can be used as a surrogate for the assessment of Bioequivalence. Several theories / kinetics models describe drug dissolution from immediate and modified release dosage forms. There are several models to represent the drug dissolution profiles where ft is a function of t (time) related to the amount ...
QUANTIFICATION OF HEALTH COMMODITIES: ARV COMPANION GUIDE Forecasting ARV Drugs Using the Morbidity
QUANTIFICATION OF HEALTH COMMODITIES: ARV COMPANION GUIDE Forecasting ARV Drugs Using the Morbidity

... A country’s forecasts need to be updated routinely (ideally quarterly, but at least semi-annually) to accommodate new ARV drug formulations and more user-friendly fixed dose combinations as they become available. More information on suppliers, packaging, storage, shelf life, and pricing of these and ...
Serum Transaminase Elevations as Indicators of - UNC
Serum Transaminase Elevations as Indicators of - UNC

... ALT is widely distributed. Human isozymes are found in the cytosol and mitochondria of liver, kidney, and skeletal and cardiac muscles (Sakagishi, 1995). Mitochondrial ALT comprises only a small portion of the tissue activity and has not been demonstrated in normal human serum. The largest pool of A ...
Multi compartment models (Delayed distribution models)
Multi compartment models (Delayed distribution models)

... such a plasma level-time profile determines the no. of kinetically homogeneous compartments into which a drug will distribute. • The simplest and commonest is the two compartment model which classifies the body tissues in two categories : 1. Central compartment or Compartment 1 2. Peripheral or Tiss ...
IOSR Journal of Pharmacy and Biological Sciences (IOSR-JPBS)
IOSR Journal of Pharmacy and Biological Sciences (IOSR-JPBS)

... at ambient temperature 25±20 C and 60±5%RH and in incubator 40±20 C and 75±5% RH for 3 months. Samples were collected at the end of 1 month, 2month and 3month and assayed to determine % drug degraded. There is no considerable degradation during the three months period of stability testing. ...
What is Nanocrystal Technology
What is Nanocrystal Technology

... • 15 products in clinical development • Extensive product development, scale-up and manufacturing capabilities in US and ...
Elan Drug Technology
Elan Drug Technology

... • 15 products in clinical development • Extensive product development, scale-up and manufacturing capabilities in US and ...
The fight against fake drugs by NAFDAC in Nigeria
The fight against fake drugs by NAFDAC in Nigeria

... high death rates. Over 150 children died in 1989 as a result of a formulation error in a drug. Such problems led to the establishment of NAFDAC, which would help create a fake-drug-free environment (NAFDAC consumer safety, 2003). The intent was to ensure effective registration of good quality drugs ...
Drugs working template
Drugs working template

... used for killing P. falciparum gametocytes and the safety of these low doses [Graves, 2015]. An important trial in Uganda showed that a dose of 04.mg/kg was as effective as the WHO recommended dose of 0.75 mg/kg [Eziefula, 2014a], and other trials of low dose regimens are in progress. However, as t ...
IOSR Journal of Pharmacy and Biological Sciences (IOSR-JPBS) e-ISSN: 2278-3008, p-ISSN:2319-7676.
IOSR Journal of Pharmacy and Biological Sciences (IOSR-JPBS) e-ISSN: 2278-3008, p-ISSN:2319-7676.

... The concept of mouth dissolving tablet also known as MDTs has emerged with an objective to improve patient‟s compliance. Methods to improve patient‟s compliance have always attracted scientists towards the development of fancy oral drug delivery systems. Among them, mouth dissolving drug delivery sy ...
How FDA Approves Drugs and Regulates Their Safety and
How FDA Approves Drugs and Regulates Their Safety and

... drugs sold in the United States. FDA divides that responsibility into two phases: preapproval (premarket) and postapproval (postmarket). FDA reviews manufacturers’ applications to market drugs in the United States; a drug may not be sold unless it has FDA approval. The agency continues its oversight ...
Investigating the role of benzodiazepines in drug-related
Investigating the role of benzodiazepines in drug-related

... later deaths in drug users from all causes.3,4 The new database was designed to provide detailed accounts of the characteristics of the individuals involved in drug-related mortality and the circumstances surrounding their deaths, and to establish a longitudinal resource to measure and observe trend ...
Drug Master Files
Drug Master Files

... Highly Regulated Markets (Drug Master Files used to support approval process) ...
Antihistamines - Take Control of your Health
Antihistamines - Take Control of your Health

... products were not included in the analysis conducted by the Oregon Health & Science University’s Drug Effectiveness Review Project, which forms the basis of this report, so we do not include them in our review. But you should know that decongestant products should be used with caution by people with ...
schering-plough gmp consent decree puts drug
schering-plough gmp consent decree puts drug

... Schering-Plough had experienced chronic problems in the manufacture of its albuterol inhaler products, which are used by patients with asthma. In September 1999, albulterol manufacturing problems led the company to issue a recall of more than 190,000 inhaler canisters because some did not contain th ...
B. Pharmacy 2009-10
B. Pharmacy 2009-10

... 6. Cultivation, collection, processing and storage of crude drugs: Factors influencing cultivation of medicinal plants. Types of soils and fertilizers of common use. Pest management and natural pest control agents. Plant hormones and their applications. Polyploidy, mutation and hybridization with re ...
Pharmacokinetics and Pharmacodynamics for Anesthesiologists
Pharmacokinetics and Pharmacodynamics for Anesthesiologists

... I hated pharmacokinetics as a medical student. There were too many logarithms, exponents, and other weird stuff. Studying pharmacokinetics meant memorizing a bunch of equations. Why would anyone waste time on that? Then I became an anesthesiologist, and found I could improve the accuracy with which ...
Riboflavin 0.1% (VibeX) for the treatment of keratoconus
Riboflavin 0.1% (VibeX) for the treatment of keratoconus

... Introduction: Keratoconus is an ectatic disease of the cornea characterized by biomechanical instability of stromal collagen leading to reduction of corneal thickness, variation in posterior and anterior corneal curvatures with associated progressive deterioration of visual acuity mainly due to a se ...
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Orphan drug

An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease.In the US and EU it is easier to gain marketing approval for an orphan drug, and there may be other financial incentives, such as extended exclusivity periods, all intended to encourage the development of drugs which might otherwise lack a sufficient profit motive. The assignment of orphan status to a disease and to any drugs developed to treat it is a matter of public policy in many countries, and has resulted in medical breakthroughs that may not have otherwise been achieved due to the economics of drug research and development.According to Thomson Reuters in their 2012 publication ""The Economic Power of Orphan Drugs"", there has been increased investing in orphan drug Research and Development partly due to the U. S. Orphan Drug Act (ODA) 1983 and similar Acts in other regions of the world and also driven by ""high-profile philanthropic funding."" The period between 2001 to 2011 was the ""most productive period in the history of orphan drug development, in terms of average annual orphan drug designations and orphan drug approvals."" For the same decade the compound annual growth rate (CAGR) of the orphan drugs was an ""impressive 25.8 percent, compared to only 20.1 percent for a matched control group of non-orphan drugs."" By 2012 the market for orphan drugs was worth USD$637 million compared to the USD$638 million matched control group of non-orphan drugs, Thomson Reuters.By 2012, ""the revenue-generating potential of orphan drugs [was] as great as for non-orphan drugs, even though patient populations for rare diseases are significantly smaller. Moreover, we suggest that orphan drugs have greater profitability when considered in the full context of developmental drivers including government financial incentives, smaller clinical trial sizes, shorter clinical trial times and higher rates of regulatory success.""
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