PDF-Guidance for Industry Limiting the Use of Certain Phthalates as Excipients in CDER Regulated

S Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER December 201 CMC brPage 2br Guidance for Industry Limiting the Use of Certain Phthalates as Excipients in CDER Regulated Products Addi. Headed by a former hearings examiner and administrative law judge, FosterLaw is well-versed in the Administrative Procedures Act, which governs most legal issues related to professional licenses. Professional licensees often require years of education and training, as well as monetary costs. Co-processed Excipients . and Simple . Mixtures . of . Excipients. What . Supporting Information is Needed to . Assess . Safety?. Dave . Schoneker. Vice Chair – Maker & Distributor Relations – IPEC Americas. DRUG EXCIPIENT COMPATIBILTY STUDY. (As a part of preformulation study). 1. INTRODUCTION. 2. INCOMPATIBILITY. -Definition. -3 Types. OBJECTIVE OF THE STUDY. -Why to screen excipients?. 1.need to minimize no of model formulations. BIOLOGY. Limiting Factors . Limiting factor: . Anything that prevents a population from growing too . large. Examples? Discuss . Space (disease, predation). Sunlight. Competition (food, water, mates). Melanie Hartsough, Ph.D.. Biologics Consulting Group, . Inc. 1. CDER: approximately 3,600 FTEs in 2013. 18 review divisions-divided based on . indication. CDER: average of 26 NMEs approved per year. Due to volume of work try to standardize requirements. Guidance for IndustryLimitingthe Use of Certain Phthalates as Excipients in CDERRegulated ProductsAdditional copies are available from:Office of CommunicationsDivision of Drug Information, WO51, Room Reactants. Suppose that you are in a car factory. . In . order to assemble a car, 4 tires and 2 headlights are needed (among other things). . In . this example, imagine that the tires and headlights are reactants while the car is the product formed from the reaction of 4 tires and 2 . Stoichiometry. !. So far. In all our reactions, we assume both reactants get used up. We assume both reactants provided are pure. We rarely see these two.. Limiting reagents. Percent Purity. Percent Yield. Bon Appetite. Suppose you are a chef preparing . F. rench toast for a group of people. You make French toast the way you have always made it: . one egg for every three slices of bread. . You never waiver from this recipe, because the French toast will be either too soggy or too dry. There are 8 eggs and 30 slices of bread in the pantry.. Concerned with identifying the identity of a substance . Or whether a specific substance is present. i.e. flame test, litmus tests. Qualitative Analysis. Determining the quantity (mass or concentration) of a specific substance present in a sample. . Limiting Reactant. Limiting Reagent. The . reactant. that is totally used up during the chemical reaction. Limits. the amount of . product. produced . Excess Reactant. Excess Reagent. The . reactant. Consider the balanced equation for the production of ammonia:. N. 2. . 3. H. 2. .  . 2. NH. 3 . If you have 2 moles of nitrogen and 3 moles of hydrogen, which reactant will be used up?. How much ammonia will you be able to make?. ?. A large, dense population or . a small, scattered population. A small, scattered population. Two . ways a population can decrease in size?. decreased birthrate and emigration. Suppose that a species of . Melissa Tassinari . Ph.D. (FDA/CDER/OND/DPMH). Jacqueline . Carleer. . Ph.D. (EMA PDCO/Chair . NcWG. ). Susan McCune MD (FDA/CDER/OTS). Nonclinical . Efficacy & Safety Studies to Support Neonatal Therapeutics: .