Case Study: Purinex‚ Inc. Introduction The case asks for evaluation of different financing options. Gilad Harpaz is Purinex’s CFO and he needs to determine which one from the three options provides lowest risk‚ highest company value‚ and short term cash for operations. Purinex is a biotechnological company that has 35 patents pending in pharmaceutical field. It is one of the raising stars that may develop new drug for specific use in diabetes and sepsis. Company has 14 employees. Monthly burden
Premium Venture capital
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R1) Current Step 4 version dated 10 June 1996 (including the Post Step 4 corrections) This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties‚ in accordance with the ICH Process. At Step 4 of the Process the
Premium Clinical trial Informed consent
Advanced Drug Formulation Design to Optimize Therapeutic Outcomes DRUGS AND THE PHARMACEUTICAL SCIENCES A Series of Textbooks and Monographs Executive Editor James Swarbrick PharmaceuTech‚ Inc. Pinehurst‚ North Carolina Advisory Board Larry L. Augsburger University of Maryland Baltimore‚ Maryland Harry G. Brittain Center for Pharmaceutical Physics Milford‚ New Jersey Jennifer B. Dressman Johann Wolfgang Goethe University Frankfurt‚ Germany Anthony J. Hickey University of
Premium Pharmacology
Marine organisms and other novel natural sources of new cancer drugs Gilberto Schwartsmann South-American Office for Anticancer Drug Development (SOAD)‚ Comprehensive Cancer Centre (CINCAN)‚ The Lutheran University (ULBRA) & Postgraduate Course in Medicine (UFRGS)‚ Porto Alegre‚ Brazil Introduction Man has always relied on nature for survival. Since ancient times‚ nature has been our main source of food‚ protection‚ clothing‚ transportation and remedies [1‚2]. This can be illustrated by the
Premium Cancer Oncology
CHANTIX® (varenicline) Tablets DESCRIPTION CHANTIX® tablets contain the active ingredient‚ varenicline (as the tartrate salt)‚ which is a partial agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline‚ as the tartrate salt‚ is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7‚8‚9‚10-tetrahydro-6‚10-methano-6H-pyrazino[2‚3h][3]benzazepine‚ (2R‚3R)-2‚3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline
Premium Renal failure Nicotine Smoking cessation
INDEX 1.Introduction to Clinical Trials 3 2.Clinical Trial Protocol 5 3.International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use 6 1.1.Introduction to GCP 6 1.2.Sections of GCP Guidelines 6 3.2.1.1Section 1- Glossary of various terms 6 3.2.1.2Section 2- Principles of ICH-GCP 7 3.2.1.3Section 3- Institutional Review Board/Independent Ethics Committee(IRB/IEC) 8 3.2.1.4Responsibilities 8 3.2.1.5Composition‚ Functions and Operations
Premium Clinical trial Clinical research
Deepak et al Journal of Drug Delivery & Therapeutics; 2012‚ 2(3): 74-86 Available online at http://jddtonline.info 74 REVIEW ARTICLE FAST DISINTEGRATING TABLETS: A NEW ERA IN NOVEL DRUG DELIVERY SYSTEM AND NEW MARKET OPPORTUNITIES *Sharma Deepak‚ Kumar Dinesh‚ Singh Mankaran‚ Singh Gurmeet‚ Rathore M.S CT Institute of Pharmaceutical Sciences‚ Shahpur‚ P.O- Udopur‚ Near Lambra‚ Jalandhar -144020‚ Punjab‚ INDIA *Corresponding Author’s Email: deepakpharmacist89@yahoo.com‚ M obile: 09988907446
Premium Tablet Dosage form Pharmacology
Shock Shock is a syndrome characterized by decreased tissue perfusion and impaired cellular metabolism. This results in an imbalance between the supply of and demand for oxygen and nutrients. The exchange of oxygen and nutrients at the cellular level is essential to life. When a cell experiences a state of hypoperfusion‚ the demand for oxygen and nutrients exceeds the supply at the microcirculatory level. Classification of Shock The four main categories of shock are * cardiogenic‚: *
Premium Blood Myocardial infarction Shock
Formulations and Formulation Development Pre-Formulation Studies Incompatibilities encountered in drug multi-component combinations and /or Drugexcipient Compatibility. Pharmaceutical Formulation Additives‚ Containers and Closures. Manufacturing and Quality control of Solid Dosage forms‚ Semi-Solid Dosage forms‚ Liquid Dosage forms‚ Sterile Dosage forms‚ Metered Dosage forms (Aerosols) Study of principles‚ Production techniques‚ Pilot batch studies‚ Scale-up Studies‚ Transfer of technology
Premium Solubility Pharmacology
b.pharma INTRODUCTION INTRODUCTION Drug Omeprazole Omeprazole is a proton pump inhibitor used in the treatment of dyspepsia‚ peptic ulcer disease (PUD)‚ gastroesophageal reflux disease (GORD/GERD)‚ laryngopharyngeal reflux (LPR)‚ and Zollinger-Ellison syndrome. It was first marketed in the US in 1989 by AstraZeneca under the brand names Losec and Prilosec‚ and is now also available from generic manufacturers under various brand names. AstraZeneca
Premium Pharmaceutical industry Sales Generic drug