国外制药工业介绍.ppt

Introduction of Pharmaceutical Business Pharmaceutical Business Heavy investment, long lead time,  high risk for product development Highly regulated, and major liability Steady growth resistant to  economic recession Important contribution to the wellbeing  of mankind Important Terminologies Rx Vs OTC –Prescription Vs Over-the-counter NDA Vs ANDA – (Abbreviated) New Drug  Application Generic Drugs – Drug without Patent  Protection Branded Drugs – Drugs sold under trade  names, usually under patent protection Patents – Method of US, Process, Formulation Important Terminologies FDA – Food Drug Administration GMP – Good Manufacturing Practice Regulatory Compliance – Adherence to GMP ICH – International Conference of  Harmonization USP – US Pharmacopoeia Important Terminologies Formulations – Dosage Forms API – Active Pharmaceutical Ingredients Excipients – Inert ingredients help to shape  the dosage forms Indication – Intended effect of medication Dosage Regimen – Methods and frequency of  consuming medicine Efficacy – Therapeutic effectiveness Safety – Side effect of drugs Important Terminologies NDA – New Drug Application ANDA – Abbreviated Drug Application Clinical Studies – Trails of drugs on patients  for tox, dose ranging, efficacy, and side  effects, etc. BA/BE – Bioavailability/Bioequivalence In-Vitro Vs In-Vivo – Outside Vs inside the  body FDA Requirements Food Food Supplements Drug and Drug Products Medical Diagnostics Medical Equipment Industry Segmentation Drug Discovery Development Manufacturing Marketing Sales New Drug Discovery Development Discovery High Throughput Screening using Existing Chemical Library Optimize Lead Structures In-Vitro Bioassay In-Vivo Animal Studies Development Formulation Development Pharmacokinetics Toxicology – 2 species Clinical Trials Phase I – Healthy Volunteers/Dosing Effect for Safety Tox Studies Phase II – Patient Efficacy Test, Simple Test Pha