Pharmacology. Scopus Biopharma will contract with qualified CRO(s) to perform standard Good Laboratory Practice (GLP) safety pharmacology studies primarily on the cannabidiol component of SB-001. The studies are anticipated to include in vitro hERG, subcutaneous (sc) rat central nervous system, sc rat respiratory system, and sc dog cardiovascular system, as well as additional studies if warranted by the data. All of the GLP safety pharmacology studies will utilize DS from either the engineering or cGMP batches.
Pharmacology. Sr No Name of Book Authors Edition Year Publisher Qty Reqd. 1 Essentials of Medical Pharmacology X X Xxxxxxxx 8thed 2018 Jaypee Brothers Medical Publisher 10 2 Principles of Pharmacology X X Xxxxxx X X Xxxxxx 3rded 2017 Paras Medical Publisher 5 3 Textbook of Pharmacology & Therapeutics X X Xxxxxxxx N NRege X X Xxxxxxxx S D Xxxxxxxxxx 25thed 2017 Elsevier 5 4 Basic & Clinical Pharmacology Xxxxxxx Xxxxxxx 14thed 2017 McGraw Hill 5 5 Pharmacology Examination & Board reviw Xxxxxxx Xxxxxx Xxxxxxx Xxxxxxx MariekeKruideri xx Xxxx 11thed 2015 McGraw Hill 2 6 Rang & Xxxx’x Pharmacology H P Rang X X Xxxxxx X X Flower X Xxxxxxxxx 8thed (Interna tional ed) 2015 Xxxxxxxxx Xxxxxxxxxxx 2 7 Fundamentals of Clinical Trials Xxxxxxxx X Xxxxxxxx Xxxx X Xxxxxxx Xxxxx X XxXxxx Xxxxx X Xxxxxxxxx Xxxxxxxxxxx x Xxxxxxx 5thed 2015 Springer Nature 2 8 Xxxxxxx & Xxxxxx’x The Pharmacological basis of Therapeutics Xxxxxxxx X Xxxxxxx 13thed 2017 McGraw Hill 2 9 Lippincott Illustrated Reviews: Pharmacology Xxxxx Xxxxxx 6thed 2014 Wolters Kluwer India Pvt Ltd 2 10 Pharmacology for MBBS X X Xxxxxxxxxx 1st 2017 Xxxxxxx Publishing Company (APC) 2 11 Fundamentals of Pharmacovigilance XxxxxXxxxx Xxxxxx Xxxxxx 1sted 2017 Paras Medical Publisher 2 12 Practical manual of Experimental & Clinical Pharmacology BikashMedhi Xxxx Xxxxxxx 2nded 2017 Jaypee Brothers Medical Publisher 2 13 Experimental Pharmacology for undergraduate & Postgraduate J Sujatadevi 1sted 2013 Jaypee Brothers Medical Publisher 1 14 Review of Pharmacology GovindraiGarg Xxxxxx Xxxxx 13thed 2019 Jaypee Brothers Medical Publisher 3 15 Practicals of Pharmacology X X Xxxxx 12thed 2017 X X Xxxx Xxxxxxxxx 2 16 Pharmacology for Medical Graduates Xxxx Xxxxxxxx XxxxxXxxxxx 4thed 2019 Elsevier India 2 17 Principles of Pharmacology Xxxxx X Xxxxx Xxxxx x Xxxxxxxxx Xxxxx X Xxxxxxxxx 4thed 2016 Xxxxxx Kluwer India Pvt Ltd 2 18 Fundamental of Experimental Pharmacology M N Ghosh 4thed 2008 X X Xxxxx and others 2 19 Clinical cases Pharmacology Toy, Xxxxx, Xxxxxxxx, Xxxxxx 3rded 2014 McGraw Hill 2 20 Current Medical Diagnosis & Treatment Xxxxxx X Xxxxxxxxx Xxxxxxx X Xxxxxx 58thed 2019 McGraw Hill 1 21 Indian Pharmacopia Indian Pharmacopoeia committee Latest edition Delhi:Manager of Publications, 1955 1 22 British National Formulary British Medical Association & Royal pharmaceutical society 76thed BMJ group and Pharmaceutical Press 1
Pharmacology. Introduction Pharmacology course for dental students is comprised of about 60-h lecture and 55-h seminars based learning. The course is performed in their third and fifth year of training. Students learn the general principals of drug action and drug disposition in the body and study the effects of disease, pregnancy, and extremes of age on drug handling. They gain the knowledge of adverse drug reactions, drug interactions and effects of drug on infants when these are given to nursing mothers. Primary Aims • To provide dental students with: • An understanding of principles of drug absorption, distribution, metabolism, excretion, mode of action and adverse drug reactions. • Knowledge of drugs used in dentistry, the relevance of a concurrent medical condition and its therapy, the use of drug in pregnancy, lactation and extremes of age. Main Objectives By the end of the course, students will be able to: • Describe methods of drug absorption, distribution, metabolism and excretion. • List the principles of drug action and drugs acting on the autonomic system. • List the actions of important autacoids and their antagonists. • List the actions of important drugs • List the groups of drug used in dentistry, their modes of action, metabolism, adverse reactions, precautions and interactions with other drugs. • List the cardiovascular drugs, drugs used in diseases of respiratory system, drugs affecting central nervous system, renal functions and anticancer drugs • Describe the precautions in prescribing drugs for pregnant and lactating women. • Describe the precautions in prescribing drugs for patients particularly susceptible because of their age or a prevailing medical condition. • Write a legal prescription for a dental patient with knowledge of drug schedules and controlled drugs under the current regulations. Hours in the Curriculum The course comprises of 2 hours of lectures and 2 hours of seminar weekly in third year of the studies. Teaching terms for dental students are longer than the traditional university terms. Currently each PBL session is of 90-minute duration. Fifteen hours of seminar are on the fifth year of training dealing with clinical pharmacology for dental students. Methods of Learning/Teaching Students learn Pharmacology from traditional lectures and from Pharmacology books. They also learn about drug treatment of various dental conditions from an extensive range of dental and medical problems under the PBL programme, which is continuously rev...
Pharmacology. Primary pharmacodynamics Secondary pharmacodynamics In vitro data In vivo data Yes Yes Yes *1 *1 Yes*1 Yes*1 Yes*1 Safety pharmacology programme Yes No Pharmacodynamic drug interactions No No Pharmacokinetics Absorption Yes Yes*1 Distribution Yes No Metabolism Excretion Pharmacokinetic drug interactions No No No No No No Toxicology Single-dose toxicity Yes Yes*1 Repeat-dose toxicity Yes No Genotoxicity Yes *1 Yes*1 Carcinogenicity No No Reproduction toxicity Toxicokinetic data Yes* 2 Yes No No Local tolerance NA NA Other toxicity studies Yes Yes*1 Ecotoxicity/environmental risk assessment Yes*1 Yes*1 Discussion on the non-clinical aspects Yes Yes *1 Data from 3,4-DAP immediate release; *2 Data obtained after approval of Firdapse® Supplementary 3 Table 1. Available data on clinical aspects for Firdapse® and 3,4-diaminopyridine slow release (3,4-DAP SR) Clinical aspects Firdapse® 3,4-DAP SR Introduction GCP Pharmacokinetics Absorption Bioequivalence Bioavailability Data available (Yes/No) Data available (Yes/No) Yes Yes Yes Yes Distribution and elimination Metabolism Dose proportionality and time dependencies Intra- and inter-individual variability Yes Yes*1 Yes*2 No Yes*2 No Yes*2 No Yes*2 No Yes*2 No No No No No Yes Yes Special populations Pharmacokinetic interaction studies Pharmacokinetics using human biomaterials Discussion on pharmacokinetics Yes Yes Yes*1 Yes*1 No No Yes*1 Yes*1 Yes*1 Yes*1 Yes Yes*1,3 Yes Yes*1 No No Yes*1 Yes*1 Yes Yes Yes*1,3 Yes*1,3 Yes*1,3 Yes*1,3 Yes*1,3 Yes*1,3 Yes*1 Yes*1 No No Yes*1 Yes*1 Yes*1,3 Yes*1,3 Yes Yes Yes Yes Pharmacodynamics Mechanism of action Pharmacology Primary pharmacology Secondary pharmacology Relation between plasma concentration and effect Pharmacodynamic interactions with other medicinal products or substances Discussion on pharmacodynamics Clinical efficacy Clinical efficacy Clinical studies in special populations Supportive studies Discussion on clinical efficacy Clinical safety Patient exposure Adverse events Serious adverse event/deaths/other significant events Laboratory findings Safety in special populations Safety related to drug-drug interactions and other interactions Discontinuation due to adverse events Post-marketing experience Discussion on clinical safety
Pharmacology. An immunosuppressive agent that is the active metabolite of azathioprine Licensed use – refer to the SPC for full information Cytotoxic agent. Mercaptopurine is indicated for the treatment of acute leukaemia. It may be utilised in remission induction and it is particularly indicated for maintenance therapy in acute lymphoblastic leukaemia and acute myelogenous leukaemia. Mercaptopurine may be used in the treatment of chronic granulocytic leukaemia. Form and strength of preparation Tablets 50mg. The tablets must be swallowed whole and not chewed. The tablets should not usually be broken or crushed. If halving a tablet is required, care should be taken not to contaminate the hands or inhale the drug. If broken tablets are handled, wash hands immediately. Side effects – refer to the SPC for full information Anorexia, nausea and vomiting, hypersensitivity (fever, rigors, rash), bone marrow suppression, hepatotoxicity, oral ulceration, CNS disturbances (headache, drowsiness, blurred vision), alopecia Rarely: pancreatitis; transient oligospermia (See BNF for comprehensive list) Very rare: Intestinal ulceration; lymphoma Bone marrow suppression: Patients should be warned to report immediately any signs or symptoms of bone marrow suppression e.g. inexplicable bruising, bleeding or infection Drug interactions – refer to the SPC for full information The following have potentially serious interaction with mercaptopurine and caution must be used when prescribing concurrently: Sulfamethoxazole (as co-trimoxazole), trimethoprim, warfarin or acenocoumarol (anticoagulant effect may be inhibited). Aminosalicylate derivatives: Lower doses of mercaptopurine may need to be considered when administered concomitantly with olsalazine, mesalazine or sulfasalazine. Avoid concomitant use of mercaptopurine with allopurinol and febuxostat (unless supervised by a specialist), and with clozapine. Contraindications and precautions – refer to the SPC for full information Contra-indications: Hypersensitivity to azathioprine / mercaptopurine Thiopurine methyltransferase deficiency (see below) Cautions: Pregnancy: Mercaptopurine should not be given to patients who are pregnant or likely to become pregnant without careful assessment of risk versus benefit. Hepatic impairment: May need to reduce dose Renal insufficiency: Reduce dose for those patients with moderate to severe renal impairment (GFR<10ml/minute; serum creatinine >300micromol/litre) In general patients should avoid “live” vaccine...
Pharmacology. BAB (OPG Farma, Utrecht, The Netherlands) was added to the extracellular solution from a stock of BAB in ethanol (1−500 mM). Final ethanol concentration never exceeded 0.1 %. Because BAB has low water solubility (<700 µM at room temperature, Merck Index 1989) and easily binds to plastic surfaces of the perfusion system, final BAB concentrations up to 500 µM were verified using absorption spectrophotometry (290 nm). m−Conotoxin−GVIA (CnTx; Peptide Institute Inc., Osaka, Japan) was dissolved in distilled water and added with a final fully blocking concentration of 3.3 or 5 µM (Xxxxxxx et al., 1995; Xxxxxxx and Xxx, 1992a; Xxxxx and Xxxx, 2002; Xxxxxxx and Xxx, 1992b). Analysis and statistics Normalized data were corrected for rundown in the presence of vehicle (0.1 % ethanol) at all potentials measured in control experiments (n = 8). For example, at test pulses of 0 mV an apparent linear barium current decline (rundown) of ~ 6 % in 5 min was observed. The concentration−inhibition data were fitted using the Hill equation: I/Io = (1 + ([BAB]/IC50)n)−1, where the IC50 is the concentration at which the current is reduced by 50% and n is the Hill coefficient. Results are presented as mean ± standard deviation (M ± SD) for n cells, unless stated otherwise, and compared using paired or independent t−tests with the level of significance (p) chosen as 0.05.
Pharmacology. Naltrexone is a competitive opioid receptor antagonist, and will block the effects of all opioids. It is thought to diminish the reinforcement which promotes drinking behaviour in alcohol use disorders by blocking the effect of alcohol-induced -endorphin release in the nucleus accumbens and the ventral tegmental area which are involved in the reward circuit in the brain. Licensed use Naltrexone is licensed in the UK and recommended as a treatment option for AUD according to NICE (Clinical Guideline 115, February 2011 xxxx://xxx.xxxx.xxx.xx/guidance/CG115 ). The Therapeutics Advisory Group (TAG) is the Area Prescribing Committee (APC) for CCGs in Norfolk & Waveney Form and strength of preparation 50mg tablets, scored Side effects Common side effects (incidence of more than 10%) - difficulty sleeping, anxiety, nervousness, abdominal pain/cramps, nausea and/or vomiting, low energy, joint and muscle pain and headache. Uncommon side effects ( incidence of less than 10%) - loss of appetite, diarrhoea, constipation, increased thirst, increased energy, feeling down, irritability, dizziness, skin rash, delayed ejaculation, decreased potency, chills, chest pain, increased sweating and increased lacrimation. Drug interactions Concomitant administration of naltrexone with an opioid-containing medication should be avoided. Patients should be warned that attempts to overcome the blockade may result in acute opioid intoxication which may be life threatening. Contraindications and precautions Contraindications Patients currently dependent on opioids since an acute withdrawal syndrome may ensue. Patients who are currently taking medication containing opioids. Patients who are hypersensitive to naltrexone. Patients with acute hepatitis or liver failure. Patients with severe renal impairment. Precautions Clients who are breast-feeding, pregnant or planning to become pregnant - Animal studies do not suggest a teratogenic effect. Because of absence of documented clinical experience naltrexone should only be given to pregnant or breast-feeding women when, in the judgement of the clinician, the potential benefits outweigh the possible risks. In an emergency requiring opioid analgesia an increased dose of opioid may be required. The patient should be closely monitored for evidence of respiratory depression or other adverse symptoms. Patents should be warned of this risk and advised to alert treating doctors. See manufacturer’s Patient Information Leaflet - Link. Initiation of th...
Pharmacology. Duloxetine is a combined serotonin (5-HT) and norepinephrine (NE) reuptake inhibitor. It weakly inhibits reuptake, with no significant affinity for histaminergic, dopaminergic, cholinergic, and adrenergic receptors. In animal studies, increased levels of 5-HT and NE in the sacral spinal cord lead to increased urethral tone via enhanced nerve stimulation to the urethral striated sphincter muscle only during the storage phase of the micturition cycle. A similar mechanism in women is believed to result in stronger urethral closure during urine storage with physical stress that could explain the efficacy of duloxetine in the treatment of women with SUI. Licensed use For the treatment of moderate to severe stress urinary incontinence (SUI) in women. Form and strength of preparation 20mg and 40mg capsules Side effects
Pharmacology. Tacrolimus is a macrolide immunosuppressant and is a calcineurin inhibitor. At the molecular level, the effects of tacrolimus appear to be mediated by binding to a cytosolic protein (FKBP12) which is responsible for the intracellular accumulation of the compound. The FKBP12-tacrolimus complex specifically and competitively binds to and inhibits calcineurin, leading to a calcium-dependent inhibition of T-cell signal transduction pathways, thereby preventing transcription of a discrete set of lymphokine genes. In particular, tacrolimus inhibits the formation of cytotoxic lymphocytes, which are mainly responsible for graft rejection. Tacrolimus suppresses T-cell activation and T-helper-cell dependent B-cell proliferation, as well as the formation of lymphokines (such as interleukins-2, -3, and γ-interferon) and the expression of the interleukin-2 receptor. Licensed use Prophylaxis of transplant rejection in liver, kidney or heart allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products. Form and strength of preparation The formulations of Tacrolimus available include: Prograf® normal release formulation - 0.5mg, 1mg and 5mg hard capsules. Adoport® normal release formulation - 0.5mg, 1mg and 5mg hard capsules. Capexion® normal release formulation - 0.5mg, 1mg and 5mg hard capsules. Tacni® normal release formulation - 0.5mg, 1mg and 5mg hard capsules. Vivadex® normal release formulation - 0.5mg, 1mg and 5mg hard capsules. Advagraf modified release capsules - 0.5mg, 1mg and 5mg prolonged-release hard capsules (a minority of patients take the modified release capsules). Envarsus® modified-release tablets -750 micrograms, 1mg, 4 mg Modigraf® sugar-free granules – 0.2mg and 1mg It is imperative that tacrolimus is prescribed by brand name, in order to avoid confusion, due to the associated risk of either toxicity or rejection should the patient receive the wrong formulation. Different brands of Tacrolimus are not interchangeable. Side effects: including - Susceptibility to infections is increased in patients taking immunosuppressive therapy. Risk of developing lymphomas and other malignancies, particularly of the skin, is increased in patients taking immunosuppressive therapy. Haematological adverse effects also include anaemia, leukopenia, thrombocytopenia, leukocytosis, pancytopenia, and neutropenia. Hypertension (adult renal patients BP >130/80mmHg) is a frequently encou...
Pharmacology. Colistin belongs to the polymyxin group of antibiotics. The polymyxins are cationic agents that work by damaging the cell membrane of bacteria that have a hydrophobic outer membrane (such as P.aeruginosa) Licensed use Treatment by inhalation of Pseudomonas aeruginosa lung infection. Therapeutics Advisory Group (TAG) is the Area Prescribing Committee (APC) for CCGs in Norfolk & Waveney Form and strength of preparation Colistin 1,000,000 units (= 1 mega unit) per vial Colistin 2,000,000 units (= 2 mega units) per vial Side effects – for a full list of side-effects please see the manufacturer’s SPC Inhalation may induce coughing or bronchospasm. Sore throat has also been reported. Due to negligible systemic absorption of colistin from the lung, the risk of systemic toxicity is low. Skin rashes have occurred during nebulised treatment. They may be a sign of hypersensitivity and will require treatment to be stopped. Drug interactions Trans-pulmonary absorption of colistin is considered to be negligible; therefore no significant interactions with systemic medication are anticipated. There are no known interactions with other inhaled/nebulised therapies. Contraindications and precautions Bronchospasm can occur. As a precaution the first (test) dose must be given under supervision, with lung function tests before and after to ensure continued suitability. Hypersensitivity to colistin or polymyxin B Patients with myasthenia gravis Criteria for patient selection Patients with bronchiectasis who grow Pseudomonas aeruginosa in their sputum or cough swab and who have required repeated admissions to hospital for IV treatment. Initiation of therapy – by whom? Treatment should only be initiated by a respiratory physician. Initial dose and administration Initial (test) dose will be given in hospital by a respiratory nurse with spirometry before and after to assess tolerability. In children who are too young to perform spirometry, assessment of tolerability will be made clinically by the specialist nurse who is administering the test dose. Maintenance dose and administration Child (1 month – 2 years): 500,000 units -1 mega unit BD Child (2-18 years): 1-2 mega units BD Adult: 2 mega units BD Reconstitution: The method used for the test dose should be continued. Any change in the diluents used will require the test dose to be repeated. Method 1: 5ml sodium chloride 0.9% Method 2: 2ml water + 2ml sodium chloride 0.9% (least likely to cause bronchoconstriction...
