Toxicology in Drug Developments课件.ppt

Toxicology in Drug Development;Outline;Parties involved in Drug Development;Sponsors;The FDA;Drug; Center for Biologics Evaluation and Research (CBER) Blood and blood products Vaccines and allergenics Conventional biotechnology-derived products recombinant proteins, monoclonal antibodies, antigenic peptides Novel biotechnology-derived products cellular or gene therapies, tissue-engineered therapies DNA vaccines, xenotransplantation;Proteins Small Molecules;又笋思船摔觉隘焊蒲我哨伟轧杠椒含妈赡搂甥香纫孩阉茄膛菩腹幸这参嗡Toxicology in Drug Developments课件Toxicology in Drug Developments课件;CDER Review Divisions;What Types of Nonclinical Studies Should Sponsors Conduct?;Guidance, Guideline, or Regulation ;The ICH Process; ICH Nonclinical Guidance Topics; FDA Nonclinical Guidance Topics;Types of Toxicology Studies Recommended;Impact of Nonclinical Studies on Drug Development;Drug Development Process;Toxicology Testing Process;What are Phase 1, 2, and 3 Trials? ;Nonclinical Information Flow;Contract Research Organizations;Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies;GLP Overview;Toxicology CRO;Study Director;Study Director;Types of Nonclinical Studies Reviewed by FDA;What Does FDA Expect from Nonclinical Studies?;What Does FDA Expect from Nonclinical Studies?;What Does FDA Expect in General Toxicology Studies?;What Does FDA Expect in General Toxicology Studies?;Timing of Nonclinical Studies - Phase 1;Timing of Nonclinical Studies - Phase 1/2;Timing of Nonclinical Studies - Phase 3; 10 rats (5M/5F) Control + 4 Dose groups Single exposure, IV Monitor clinical observations, food consumption, serum chemistry, hematology, coagulation over 7 days (+ baseline) Serum PK Gross observations, histopathology on major organs and tissues ; 32 cynomolgus nonhuman primates (16M/16F) Control (5M/5F), Low (3M/3F), Med (3M/3F), High (5M/5F) Repeated exposure over 4 weeks, Sac 3M/3F, 4 week recovery Monitor clinical observations, food consumption, serum chemistry, hematology, coa