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. The aim of treatment is to reduce the production and absorption of ammonia in the gut. Current management of acute episodes of hepatic encephalopathy involves the use of antibiotics (such as neomycin) to inhibit ammonia- generating bacteria and disaccharides such as lactulose to convert soluble ammonia to insoluble ammonium. People with hepatic encephalopathy with low plasma ammonia may receive treatment with lactulose for the prevention of recurrence of acute episodes of hepatic encephalopathy. Rifaximin has a broad spectrum of activity against gram positive and gram negative, aerobic and anaerobic bacteria. In inhibiting the division of urea- deaminating bacteria, rifaximin decreases intestinal production and absorption of ammonia. It is administered orally and not systemically absorbed. The use of rifaximin has been demonstrated to reduce hospital admissions as a result of OHE and maintains remission in people with recurrent episodic OHE.3
Pharmacology. Patients may wish to receive behavioural support only, i.e. without pharmacological support, namely Withdrawal Oriented Treatment (‘WOT’). If however considered appropriate, the GP Practice/Pharmacy Adviser may supply treatment from the locally agreed formulary and the pharmacist will advise on its use. Supply of treatment should be recorded on the person’s pharmacy medication record. Approved Berkshire Stop Smoking Services formulary is provided in training available for Stop Smoking Specialist Advisers. Where patients require additional support to stop smoking, first line treatment with Nicotine Replacement Therapy (NRT) should be offered. Only where NRT has been unsuccessful should an adviser consider recommending Varenicline through a PGD. No recommendation should be made for a specific drug by the adviser. Varenicline (Champix) should be used in conjunction with a 12 week behavioural stop smoking support programme, as per current Berkshire priorities guidelines. The patient’s progress should be monitored throughout the treatment and can be referred to the stop smoking service if required. Prescribing intervals should be short; continued supply being dependent upon abstinence from smoking and attending the stop smoking programme.
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. Ciclosporin is thought to bind to the cytosolic protein cyclophilin (immunophilin) of immunocompetent lymphocytes, especially T-lymphocytes. This complex of ciclosporin and cyclophilin inhibits calcineurin, which, under normal circumstances, is responsible for activating the transcription of interleukin 2. It also inhibits lymphokine production and interleukin release and, therefore, leads to a reduced function of effector T-cells. Ciclosporin is an immunomodulator which acts upon T lymphoctes. Ciclosporin suppresses the immune system by preventing T lymphocytes from producing lymphokines. Lymphokines normally stimulate the growth of T and B lymphocytes, which are cells responsible for regulating and triggering immune responses. T cells are involved in producing inflammation as part of their immune function. Suppressing their action can help to reduce the inflammation in the joints of people who have rheumatoid arthritis or reduce inflammation in the skin of people who have cutaneous inflammatory conditions. Ciclosporin can promote a Th1 response in atopic dermatitis, altering IL-4 transcription and monocyte IL-10 production. Ciclosporin also has a direct effect on keratinocytes. 40% of an oral dose of ciclosporin is absorbed from the gut. Metabolism is hepatic and excretion is mostly in the bile with only 6% via urinary tract. Licensed use • Prevention of organ rejection • Treatment of rheumatoid arthritis and psoriasis • Short term treatment of severe atopic dermatitis Non licensed dermatological indications include: Behcet’s disease, Chronic idiopathic urticaria, Connective tissue disease, immunobullous disease, Pyoderma gangrenosum, photodermatoses. Form and strength of preparation and dosages Ciclosporin (oral solution or soft gelatin capsule) given twice a day based on patient’s weight, initially 2.5mg/kg/day. Available in 10mg, 25mg, 50mg or 100mg gelatin capsules or 100mg/ml solution. The solution can be mixed with fruit juice to improve the taste, but not grapefruit juice (this contains the flavinoid narigenin which inhibits CYP 3A4 activity and can increase plasma concentration of ciclosporin). Ciclosporin is given in divided doses from 2.5 to 4mg/kg/day in rheumatoid arthritis, and 2.5 to 5mg/kg/day in dermatology. Side effects • Tingling and numbness in the hands and feet: This usually subsides with time. • Trembling hands and feet and muscle cramps: Tonic water may help to alleviate any cramp pain. • Hypertrichosis: Increased growth of body ha...
Pharmacology. Results of extensive pharmacodynamic evaluation demonstrating proof of concept in vivo for the immunotherapeutic construct selected for human health development. SAFETY EVALUATION Results of acute and subacute (less than or equal to 6 weeks) studies in two species, conducted to GLP, demonstrating the expected pharmacologically mediated effects on gonadal and associated organs (e.g. seminal vesicles; uterus) and the absence of non-mechanistic toxicity. CHEMISTRY AND PHARMACY Clinical trial supplies formulated and manufactured by a validated process and demonstrated to have biological potency in an in vivo batch release study. CLINICAL DEVELOPMENT CTX APPLICATION Documentation from above programme prepared in CTX format scheduled for submission in 3/4th week April 1996. CLINICAL TRIAL ORGANIZATION Protocol and associated documentation for initial proof of concept study in prostate cancer patients. Principal investigator identified. FORMULATION The process of Formulation of the Conjugate to facilitate the manufacture of Products.
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. Xx. Xxxxxxx Xxxxxxxx E-mail: xxxxx@xxx.xx
Pharmacology. Methylphenidate, dexamfetamine and lisdexamfetamine (a pro-drug for dexamfetamine) are centrally-acting sympathomimetics. Their mechanism of action is mainly through inhibition of noradrenaline and dopamine transporters. Methylphenidate and lisdexamfetamine are the NICE treatments of first choice. Atomoxetine is a noradrenaline reuptake inhibitor which indirectly boosts dopamine. Licensed use Drug prescribing in adults is usually off-label. Exceptions are atomoxetine, which is licensed for new treatment in adults with ADHD symptoms that can be confirmed from childhood, and lisdexamfetamine (as Elvanse Adult®) and Medikinet XL which is indicated as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in adults. Clinicians are supported in prescribing for adults with ADHD by the NICE NG 87, BAP (British Association of Psychopharmacology) guidelines. Forms and strengths of preparations Three types of methylphenidate multiphasic XL preparations are available: • Concerta XL®, Matoride XL®, Xenidate XL® , Delmosart® or Xaggitin XL® tablets (22% Immediate Release [IR], 78% extended release [XL]) (See Appendix 1 for comparative costs of these once-daily methylphenidate products) • Equasym XL® capsules (30% IR, 70% XL) • Medikinet XL® capsules (50% IR, 50% XL) These different types of products are not interchangeable and the BNF recommends prescribing by brand name to avoid the risk of destabilisation from different release characteristics of the XL products dispensed generically. Strengths of Methylphenidate modified-release products: (22% Immediate Release [IR], 78% extended release [XL]) Concerta XL®: capsule-shaped tablets with internal hard membrane, 18mg (equivalent to 15mg of plain tablets), 27mg, 36mg or 54mg in packs of 28, or 30 Matoride XL®: cylindrical tablets with internal hard membrane, 18mg (equivalent to 15mg of plain tablets), 36mg or 54mg in packs of 28, 30, 60 or 90 Xenidate XL®: round, biconvex tablets, 18mg (equivalent to 15mg of plain tablets), 27mg, 36mg or 54mg in packs of 28, 30 or 100 Delmosart®: capsule-shaped, biconvex tablets, 18mg (equivalent to 15mg of plain tablets), 27mg, 36mg or 54mg in packs of 28, 30 or 90 Xaggitin XL®: capsule-shaped, biconvex tablets, 18mg (equivalent to 15mg of plain tablets), 27mg, 36mg or 54mg in packs of 28, 30 or 90 (See Appendix 1 for comparative costs of these methylphenidate products) Equasym XL®: (30% IR, 70% XL) capsules with small globules inside, 10mg, 20mg...
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
