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Product Name: Ibuprofen Oral Suspension 100mg/5mL
Product Name: Ibuprofen Oral Suspension 100mg/5mL

... 1ug/mL did not demonstrate ibuprofen in the milk of lactating mothers. Because of the limited nature of these studies, however, and the possible adverse effects of prostaglandin inhibiting drugs on newborns, this drug is not recommended for use in nursing mothers. The safety and effectiveness in ped ...
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Modified-release preparations
Modified-release preparations

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Part 5: How Do I Design and Adjust a Dosage Regimen
Part 5: How Do I Design and Adjust a Dosage Regimen

... In other words, the amount of drug that must be given to achieve rapidly a target concentration of drug in the plasma is solely determined by VD, B and [D]P(target). ...
Drug Effects on the Fetus and Breast-Fed Infant
Drug Effects on the Fetus and Breast-Fed Infant

... pregnancy experience, so the estimation of pregnancy risk is difficult at best. Three methods to reduce the risks arising from treating pregnant women with drugs are readily apparent: try to use only those agents considered relatively safe in pregnancy; if a drug known to be toxic must be used, avoi ...
Modern Methods in Drug Discovery WS06/07
Modern Methods in Drug Discovery WS06/07

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In-Vitro-In-Vivo Correlation Definitions and Regulatory
In-Vitro-In-Vivo Correlation Definitions and Regulatory

... specifications. This is because the IVIVC includes in-vivo relevance to invitro dissolution specification. In other words, dissolution specifications are set based on the performance of the biobatch in-vivo. The general dissolution time point specification is ± 10% deviation from the mean dissolutio ...
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7. Calculation of Doses- General considerations.ppt [相容模式]

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17.Ramdas T. Dolas, Dr. Avinash Hosmani and Sachin B. Somwanshi
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Drugs of Abuse - QML Pathology
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review - International Research Journal of Pharmacy
review - International Research Journal of Pharmacy

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Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

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Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

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Drug Delivery from Devices

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Pharmacokinetics and doses of anti-TB drugs in children
Pharmacokinetics and doses of anti-TB drugs in children

... • To rapidly kill most bacilli in order to: - prevent disease progression - prevent transmission of infection - prevent development of drug resistance Continuation phase • To effect cure and prevent relapse (eliminate dormant bacilli) ...
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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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