CTIMP Protocol development tool
... The background should be supported by appropriate references to the published literature on the disease or condition, its treatment and the use of the trial drug for the indication and contain: ...
... The background should be supported by appropriate references to the published literature on the disease or condition, its treatment and the use of the trial drug for the indication and contain: ...
PS13_Letovsky_FDA_Workshop_9_06
... Costs and Benefits of Biomarkers in Clinical Trials Washington D.C. September 29, 2006 ...
... Costs and Benefits of Biomarkers in Clinical Trials Washington D.C. September 29, 2006 ...
isoniazid
... • Isoniazid is an antibiotic. It prevents tuberculous bacteria from multiplying in the body. • Isoniazid is used to treat and to prevent tuberculosis (TB). • Isoniazid may also be used for purposes other than those listed in this medication guide. ...
... • Isoniazid is an antibiotic. It prevents tuberculous bacteria from multiplying in the body. • Isoniazid is used to treat and to prevent tuberculosis (TB). • Isoniazid may also be used for purposes other than those listed in this medication guide. ...
PRODUCT INFORMATION ZOLOFT (sertraline hydrochloride) NAME OF THE MEDICINE
... established in two multicentre placebo-controlled studies of adult outpatients who met DSM-IV criteria for Social Phobia (Social Anxiety Disorder). These criteria involve a marked and persistent fear or anxiety of behaving in an embarrassing or humiliating manner while under the gaze of other people ...
... established in two multicentre placebo-controlled studies of adult outpatients who met DSM-IV criteria for Social Phobia (Social Anxiety Disorder). These criteria involve a marked and persistent fear or anxiety of behaving in an embarrassing or humiliating manner while under the gaze of other people ...
Pocket Reference for ICU Staff
... Information in this booklet should be used as a guide only. The prescriber is responsible for the verification of indications and dosages listed in the manufacturers’ package insert for the individual drugs, from which most information for this dosing guide is obtained. The prescriber should also no ...
... Information in this booklet should be used as a guide only. The prescriber is responsible for the verification of indications and dosages listed in the manufacturers’ package insert for the individual drugs, from which most information for this dosing guide is obtained. The prescriber should also no ...
Hydroxyzine Hydrochloride Injection, USP Hydroxyzine
... Hydroxyzine Hydrochloride Injection, USP is a sterile aqueous solution intended for intramuscular administration. Each mL contains: Hydroxyzine HCl 25 mg or 50 mg, Benzyl Alcohol 0.9%, and Water for Injection q.s. pH adjusted with Sodium Hydroxide and/or Hydrochloric Acid. CLINICAL PHARMACOLOGY: Hyd ...
... Hydroxyzine Hydrochloride Injection, USP is a sterile aqueous solution intended for intramuscular administration. Each mL contains: Hydroxyzine HCl 25 mg or 50 mg, Benzyl Alcohol 0.9%, and Water for Injection q.s. pH adjusted with Sodium Hydroxide and/or Hydrochloric Acid. CLINICAL PHARMACOLOGY: Hyd ...
View Product Information
... impair absorption and should not be given to patients taking doxycycline. Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracyclines in conjunction with penicillin. Because the tetracyclines have been shown to depress plasma pro ...
... impair absorption and should not be given to patients taking doxycycline. Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracyclines in conjunction with penicillin. Because the tetracyclines have been shown to depress plasma pro ...
AGIOS PHARMACEUTICALS INC (Form: 8-K
... This Form 8-K and the exhibits attached hereto contain forward-looking statements of Agios Pharmaceuticals, Inc. (“Agios” or the “Company”) within the meaning of The Private Securities Litigation Reform Act of 1995, including statements regarding Agios’ expectations and beliefs about its business, p ...
... This Form 8-K and the exhibits attached hereto contain forward-looking statements of Agios Pharmaceuticals, Inc. (“Agios” or the “Company”) within the meaning of The Private Securities Litigation Reform Act of 1995, including statements regarding Agios’ expectations and beliefs about its business, p ...
Drug induced hypersalivation
... d) Antimuscarinic agents will have additive side effects with clozapine so patients should be observed for worsening of these side effects e.g. constipation (64). Cognitive function may also be impaired. Pirenzepine, glycopyrronium and ipratropium are believed to have little CNS penetration. Periphe ...
... d) Antimuscarinic agents will have additive side effects with clozapine so patients should be observed for worsening of these side effects e.g. constipation (64). Cognitive function may also be impaired. Pirenzepine, glycopyrronium and ipratropium are believed to have little CNS penetration. Periphe ...
Adverse Drug Interactions In Dental Practice
... are still used in patients intolerant of or unresponsive to the newer drugs. They are also prescribed for the treatment of severe anxiety disorders, neuropathic pain, nocturnal enuresis and attention deficit hyperactivity disorder. The tricyclic antidepressants block the active reuptake of biogenic ...
... are still used in patients intolerant of or unresponsive to the newer drugs. They are also prescribed for the treatment of severe anxiety disorders, neuropathic pain, nocturnal enuresis and attention deficit hyperactivity disorder. The tricyclic antidepressants block the active reuptake of biogenic ...
Development of a Common Cyclobenzaprine
... made them uniquely suitable for blinding a new drug and its positive comparators in early clinical trials. The trials are usually designed to compare one medication with another to evaluate the relative safety and/or efficacy of the new drug. In those tests, it is a common practice to blind the medi ...
... made them uniquely suitable for blinding a new drug and its positive comparators in early clinical trials. The trials are usually designed to compare one medication with another to evaluate the relative safety and/or efficacy of the new drug. In those tests, it is a common practice to blind the medi ...
Full Text - The Journal of International Advanced Otology
... Materials and Methods: Forty patients, classified as ASA physical status I-II and candidates for middle ear surgery were randomly allocated into two groups by sealed-envelope method. Before induction Group D (n=20) received 0.1 µg/kg/min dexmedetomidine for 10 minutes and Group A (n=20) received 20 ...
... Materials and Methods: Forty patients, classified as ASA physical status I-II and candidates for middle ear surgery were randomly allocated into two groups by sealed-envelope method. Before induction Group D (n=20) received 0.1 µg/kg/min dexmedetomidine for 10 minutes and Group A (n=20) received 20 ...
HƯỚNG DẪN VỀ DƯỢC PHẨM INCIVEK
... INCIVEK must not be used as monotherapy and must only be used in combination with peginterferon alfa and ribavirin. (5.6) A high proportion of previous null responders (particularly those with cirrhosis) did not achieve Sustained Virologic Response (SVR) and had telaprevir resistance-associated subs ...
... INCIVEK must not be used as monotherapy and must only be used in combination with peginterferon alfa and ribavirin. (5.6) A high proportion of previous null responders (particularly those with cirrhosis) did not achieve Sustained Virologic Response (SVR) and had telaprevir resistance-associated subs ...
A Focus on Clinical Trials
... The instrument should be widely accepted as a measurement of drug outcomes in that specific patient group and condition. As evidenced by discussion of the endpoint/instrument in at least one of the following: • a TMA within the therapeutic area (not required to be the sponsor’s TMA) • consensus guid ...
... The instrument should be widely accepted as a measurement of drug outcomes in that specific patient group and condition. As evidenced by discussion of the endpoint/instrument in at least one of the following: • a TMA within the therapeutic area (not required to be the sponsor’s TMA) • consensus guid ...
Topical Corticosteroids: Making Sense of the Options
... surgical applications, the aim of corticosteroid prescribing is first of all to prevent, rather than suppress, inflammation. The thought here is that side effects can be effectively minimized by reducing not the concentration of drug but the duration of therapy. To inhibit inflammation in cataract s ...
... surgical applications, the aim of corticosteroid prescribing is first of all to prevent, rather than suppress, inflammation. The thought here is that side effects can be effectively minimized by reducing not the concentration of drug but the duration of therapy. To inhibit inflammation in cataract s ...
us equine
... • Administer by intramuscular injection at the dosage of 1 to 2 mg ceftiofur per pound of body weight, with a maximum of 10 mL per injection site. • Treatment should be repeated at 24 hour intervals, and continued for 48 hours after clinical signs have disappeared but should not exceed 10 days. IM ...
... • Administer by intramuscular injection at the dosage of 1 to 2 mg ceftiofur per pound of body weight, with a maximum of 10 mL per injection site. • Treatment should be repeated at 24 hour intervals, and continued for 48 hours after clinical signs have disappeared but should not exceed 10 days. IM ...
Maraviroc (Selzentry)
... • The CD4+ cell count advantage of MVC over PBO was driven not only by those patients who achieved virologic suppression, but also by those who never achieved this goal • Since treatment group was found to be associated with CD4+ cell rises, these findings together suggest that MVC increases CD4+ ce ...
... • The CD4+ cell count advantage of MVC over PBO was driven not only by those patients who achieved virologic suppression, but also by those who never achieved this goal • Since treatment group was found to be associated with CD4+ cell rises, these findings together suggest that MVC increases CD4+ ce ...
A role for D2 but not D1 dopamine receptors in the cross
... Carr et al. (2001). Testing began with 30-min habituation sessions in the open field activity chamber once per day for three consecutive days. The baseline bars provided in Fig. 1A–C represent the first 15 min in the activity chambers during the last habituation session which occurred 1 day before t ...
... Carr et al. (2001). Testing began with 30-min habituation sessions in the open field activity chamber once per day for three consecutive days. The baseline bars provided in Fig. 1A–C represent the first 15 min in the activity chambers during the last habituation session which occurred 1 day before t ...
Pharmacokinetics - Therapeutic Goods Administration
... Intracellular pharmacokinetics: In a clinical study the intracellular half-life of emtricitabine-triphosphate in peripheral blood mononuclear cells (PBMCs) was 39 hours and intracellular triphosphate levels increased with dose, but reached a plateau at doses of 200 mg or greater. Pharmacokinetic Dru ...
... Intracellular pharmacokinetics: In a clinical study the intracellular half-life of emtricitabine-triphosphate in peripheral blood mononuclear cells (PBMCs) was 39 hours and intracellular triphosphate levels increased with dose, but reached a plateau at doses of 200 mg or greater. Pharmacokinetic Dru ...
A Nomogram for Valproic Acid and the Effect of Missed Doses
... Table 2.3: Dosing recommendations for ER based on free VPA. .....................................45 Table 2.4: Dosing recommendations for DR based on free VPA......................................46 Table 3.1: Predictions for percent increase in dose based on individual estimates ...........76 Table ...
... Table 2.3: Dosing recommendations for ER based on free VPA. .....................................45 Table 2.4: Dosing recommendations for DR based on free VPA......................................46 Table 3.1: Predictions for percent increase in dose based on individual estimates ...........76 Table ...
Clofazimine (Lamprene, B663) in the Treatment of Lepromatous
... In virtually all cases this included quite long periods during which dapsone was taken in low dosage, or not at all. " High level of dapsone in the mouse fed 0.01%: equivalent to a dose of 100 mg dapsone/day in man. Intermediate and low levels of dapsone in mice fed 0.001% and 0.0001%: equivalent to ...
... In virtually all cases this included quite long periods during which dapsone was taken in low dosage, or not at all. " High level of dapsone in the mouse fed 0.01%: equivalent to a dose of 100 mg dapsone/day in man. Intermediate and low levels of dapsone in mice fed 0.001% and 0.0001%: equivalent to ...
appendix b
... have shown increased response rates (see below), these combinations have not proven to be superior to single agent DTIC for the general population. Similarly, a Phase III study comparing temozolomide to DTIC showed no substantial improvement in survival or in other primary clinical endpoints (3). A ...
... have shown increased response rates (see below), these combinations have not proven to be superior to single agent DTIC for the general population. Similarly, a Phase III study comparing temozolomide to DTIC showed no substantial improvement in survival or in other primary clinical endpoints (3). A ...
Potential antimicrobial agents for the treatment of multidrug-resistant tuberculosis
... MIC: minimum inhibitory concentration; +: selected drug has bactericidal activity; –: selected drug has no bactericidal activity; +/–: selected drug has bactericidal activity in one study and no activity in other studies; NA: not available; CNS: central nervous system; CSF: cerebrospinal fluid; TB: ...
... MIC: minimum inhibitory concentration; +: selected drug has bactericidal activity; –: selected drug has no bactericidal activity; +/–: selected drug has bactericidal activity in one study and no activity in other studies; NA: not available; CNS: central nervous system; CSF: cerebrospinal fluid; TB: ...