16th International Conference of Drug Regulatory Authorities (ICDRA)
... the following recommendations are made. Member States Ensure there are emergency use regulatory pathways in place; ensure there is rapid and proactive cooperation and collaboration between regulators, and also with WHO, to help accelerate development and evaluation of investigational treatments and ...
... the following recommendations are made. Member States Ensure there are emergency use regulatory pathways in place; ensure there is rapid and proactive cooperation and collaboration between regulators, and also with WHO, to help accelerate development and evaluation of investigational treatments and ...
Chapter 1
... Pharmacology • A drug is any chemical substance that produces a biologic response in a living system. • A drug is a substance used as medicine to aid in the diagnosis, treatment, or prevention of disease. • The science concerned with the origin, nature, effects, and uses of drugs is called pharmacol ...
... Pharmacology • A drug is any chemical substance that produces a biologic response in a living system. • A drug is a substance used as medicine to aid in the diagnosis, treatment, or prevention of disease. • The science concerned with the origin, nature, effects, and uses of drugs is called pharmacol ...
How is “safety” - Global Campaign for Microbicides
... 2) STIs are significant causes of morbidity and mortality. Many people are at much greater risk of STIs than HIV. 3) Many microbicides active against HIV have overlapping mechanisms of action against other STIs. Source: Rockefeller Report. The Science of Microbicides ...
... 2) STIs are significant causes of morbidity and mortality. Many people are at much greater risk of STIs than HIV. 3) Many microbicides active against HIV have overlapping mechanisms of action against other STIs. Source: Rockefeller Report. The Science of Microbicides ...
Gastroretentive drug delivery systems: a review
... methylcellulose (HPMC), and floating system based on ion exchange resin technology etc [3]. Bilayer or multilayer system has also been designed [41, 42]. Drugs and excipients can be formulated independently and the gas generating material can be incorporated in to any of the layers. Further modifica ...
... methylcellulose (HPMC), and floating system based on ion exchange resin technology etc [3]. Bilayer or multilayer system has also been designed [41, 42]. Drugs and excipients can be formulated independently and the gas generating material can be incorporated in to any of the layers. Further modifica ...
Microbiology Guide to Interpreting Minimum Inhibitory Concentration
... Next to each antibiotic is the susceptibility interpretation: S (sensitive), I (intermediate) or R (resistant), followed by the MIC in μg/ml. Sensitive implies that the organism is inhibited by the serum concentration of the drug that is achieved using the recommended dosage; intermediate includes i ...
... Next to each antibiotic is the susceptibility interpretation: S (sensitive), I (intermediate) or R (resistant), followed by the MIC in μg/ml. Sensitive implies that the organism is inhibited by the serum concentration of the drug that is achieved using the recommended dosage; intermediate includes i ...
ICRF Phase I Additional Information - Imperial CRF
... Experience of Experimental Medicine studies or CTIMP studies in last 3 years? Select No. of studies and role: Experience of Phase I trials: Select No. of trials and role: Experience of FIH trials: Select No. of trials and role: Experience of studies with dose escalation: Select No. of trials and rol ...
... Experience of Experimental Medicine studies or CTIMP studies in last 3 years? Select No. of studies and role: Experience of Phase I trials: Select No. of trials and role: Experience of FIH trials: Select No. of trials and role: Experience of studies with dose escalation: Select No. of trials and rol ...
Good Manufacturing Practices (“GMPs”)
... that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.” 21 CFR 211.22(a) ...
... that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.” 21 CFR 211.22(a) ...
Pharmacokinetics and doses of anti-TB drugs in children
... Discussion MFX in children 7-15 years of age receiving 10mg/kg MFX • PK: Shorter t1/2 and lower AUC relative to published values in adults receiving 400mg MFX despite this being an older paediatric population • PD indices (adult targets) not achieved – Efficacy of Mfx in adults with TB shown in sev ...
... Discussion MFX in children 7-15 years of age receiving 10mg/kg MFX • PK: Shorter t1/2 and lower AUC relative to published values in adults receiving 400mg MFX despite this being an older paediatric population • PD indices (adult targets) not achieved – Efficacy of Mfx in adults with TB shown in sev ...
PCSK9 Inhibitors Praluent
... respective gene that reduces the liver's ability to remove LDL cholesterol before it is released into the bloodstream. Restricting this protein’s ability to hinder the liver by using PCSK9-inhibiting drugs has shown to lower LDL-C as much as 52%. Studies to date have shown that adverse events are ma ...
... respective gene that reduces the liver's ability to remove LDL cholesterol before it is released into the bloodstream. Restricting this protein’s ability to hinder the liver by using PCSK9-inhibiting drugs has shown to lower LDL-C as much as 52%. Studies to date have shown that adverse events are ma ...
Antifungal Drugs
... Conc. in plasma is same by oral or IV route Has the least effect on hepatic microsomal enzymes ...
... Conc. in plasma is same by oral or IV route Has the least effect on hepatic microsomal enzymes ...
Buprenorphine
... physician ability to maintain an addiction • 1960s: redevelopment of maintenance model • 1972: FDA approval and strict regulation of methadone Joseph, 2000 ...
... physician ability to maintain an addiction • 1960s: redevelopment of maintenance model • 1972: FDA approval and strict regulation of methadone Joseph, 2000 ...
Prevalence and predictors of potential drug
... During the study, prescriptions for 4467 patients were analyzed, 2558 clinical significant potential DDIs were identified among 1488 exposed patients (Table 1). Nine hundred and twenty one (36%) DDIs were rated as 1 and 1637 (64%) as 2, corresponding to 136 drug combinations. The mean number of DDIs ...
... During the study, prescriptions for 4467 patients were analyzed, 2558 clinical significant potential DDIs were identified among 1488 exposed patients (Table 1). Nine hundred and twenty one (36%) DDIs were rated as 1 and 1637 (64%) as 2, corresponding to 136 drug combinations. The mean number of DDIs ...
product monograph
... CARDURA is also indicated for the treatment of symptoms of benign prostatic hyperplasia (BPH). The onset of effect is rapid, with improvement in peak flow and symptoms observed within 1-2 weeks. The effect on these variables was maintained over the entire study duration (up to 4 years). CARDURA may ...
... CARDURA is also indicated for the treatment of symptoms of benign prostatic hyperplasia (BPH). The onset of effect is rapid, with improvement in peak flow and symptoms observed within 1-2 weeks. The effect on these variables was maintained over the entire study duration (up to 4 years). CARDURA may ...
ANAFRANIL PRODUCT INFORMATION
... emergence of suicidal ideation and behaviours (suicidality) whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored for ...
... emergence of suicidal ideation and behaviours (suicidality) whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored for ...
CONCERTATM methylphenidate HCl QUALITATIVE AND
... and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior or hostility, patients beginning treatment for ADHD should be monitored for the appear ...
... and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior or hostility, patients beginning treatment for ADHD should be monitored for the appear ...
DFWP Prescription Drug Module 9.2007
... What’s the big deal? “How could it be bad if it’s medicine?” “But my doctor told me to take it.” “They’re legal and certainly not as dangerous as street drugs.” ...
... What’s the big deal? “How could it be bad if it’s medicine?” “But my doctor told me to take it.” “They’re legal and certainly not as dangerous as street drugs.” ...
Effects of Advanced Liver Disease on drug PK
... and express genes that simultaneously drive both proliferation and apoptosis, with a later effect on metabolism Both, however, recovered more than 2 months after transplantation, indicating that either mature hepatocytes or a subpopulation of adult stem cells are capable of full recovery in severe c ...
... and express genes that simultaneously drive both proliferation and apoptosis, with a later effect on metabolism Both, however, recovered more than 2 months after transplantation, indicating that either mature hepatocytes or a subpopulation of adult stem cells are capable of full recovery in severe c ...
NOACs versus warfarin for stroke prevention in patients with AF: a
... Description of the intervention and how it might work Novel oral anticoagulants (NOACs) have a more specific mode of action directly targeting just one clotting factor. The factor Xa inhibitors and direct thrombin (factor IIa) inhibitors produce a more predictable and less labile anticoagulant effect ...
... Description of the intervention and how it might work Novel oral anticoagulants (NOACs) have a more specific mode of action directly targeting just one clotting factor. The factor Xa inhibitors and direct thrombin (factor IIa) inhibitors produce a more predictable and less labile anticoagulant effect ...
The over-the-counter pharmaceutical market - policy and practice
... of medicines is governed by a regulatory framework which is based on perceptions of the risks and benefits of the medicine to the population. In the UK, for example, there are three broad categories of medicines: POM (prescription only medicines), P (pharmacy supervised sale), and GSL (general sales ...
... of medicines is governed by a regulatory framework which is based on perceptions of the risks and benefits of the medicine to the population. In the UK, for example, there are three broad categories of medicines: POM (prescription only medicines), P (pharmacy supervised sale), and GSL (general sales ...
Appendix B
... Smokers need higher doses of theophylline than nonsmokers due to theophylline’s shortened half-life and increased elimination. Some reports suggest smokers may need twice the dose of nonsmokers. ...
... Smokers need higher doses of theophylline than nonsmokers due to theophylline’s shortened half-life and increased elimination. Some reports suggest smokers may need twice the dose of nonsmokers. ...
Forced Drugging Defense Package - Law Project for Psychiatric Rights
... defense and are not discovering and presenting to judges the evidence of the harm to their clients." In addition to lawyer indifference, most appointed lawyers do not have funding to obtain expert testimony even when they might want to do a good job for their clients. In trying to address this probl ...
... defense and are not discovering and presenting to judges the evidence of the harm to their clients." In addition to lawyer indifference, most appointed lawyers do not have funding to obtain expert testimony even when they might want to do a good job for their clients. In trying to address this probl ...
Bad Pharma
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Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients is a book by British physician and academic Ben Goldacre about the pharmaceutical industry, its relationship with the medical profession, and the extent to which it controls academic research into its own products. The book was published in September 2012 in the UK by the Fourth Estate imprint of HarperCollins, and in February 2013 in the United States by Faber and Faber.Goldacre argues in the book that ""the whole edifice of medicine is broken"" because the evidence on which it is based is systematically distorted by the pharmaceutical industry. He writes that the industry finances most of the clinical trials into its own products and much of doctors' continuing education, that clinical trials are often conducted on small groups of unrepresentative subjects and negative data is routinely withheld, and that apparently independent academic papers may be planned and even ghostwritten by pharmaceutical companies or their contractors, without disclosure. Goldacre calls the situation a ""murderous disaster,"" and makes suggestions for action by patients' groups, physicians, academics and the industry itself.Responding to the book's publication, the Association of the British Pharmaceutical Industry issued a statement arguing that the examples the book offers are historical, that the concerns have been addressed, that the industry is among the most regulated in the world, and that it discloses all data in accordance with international standards.In January 2013 Goldacre joined the Cochrane Collaboration, British Medical Journal and others in setting up AllTrials, a campaign calling for the results of all past and current clinical trials to be reported. The British House of Commons Public Accounts Committee expressed concern in January 2014 that drug companies were still only publishing around 50 percent of clinical-trial results.