Non-clinical Dose Formulation Analysis

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Final Formulation & Non-Clinical Drug Development“With the exception of the varying concentrations of the active product, the drug to be applied should be in itsFINAL FORMULATION and (…) a NONCLINICAL study duration of two weeks should generally be used.”NONCLINICAL PHARMACOLOGY/TOXICOLOGY DEVELOPMENT OF TOPICAL DRUGS INTENDED TO PREVENT THE TRANSMISSIONOF SEXUALLY TRANSMITTED DISEASES (STD) AND/OR FOR THE DEVELOPMENT OF DRUGS INTENDED TO ACT AS VAGINAL CONTRACEPTIVES,DOCUMENT IS AN INFORMAL COMMUNICATION UNDER 21 CFR 10.90 (b) (9) FDA 2009“We recommend that the FORMULATION USED TO ESTABLISH SAFETY MARGINS IN NONCLINICAL studiesBE IDENTICAL to the formulation that will be used IN CLINICAL TRIALS and that is intended formarketing. We also recommend that any differences in the formulations used in the clinical trials andnonclinical studies be specified so that any impact on the adequacy of the nonclinical studies can bedetermined.”MEDICAL IMAGING DRUG AND BIOLOGICAL PRODUCTS PART 1: CONDUCTING SAFETY ASSESSMENTS, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD ANDDRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH (CDER) CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER) MAY 2003www.filab.com.pl
Final Formulation & Non-Clinical ……“It is essential to determine the concentration of each isomer and define limits for all isomericcomponents, impurities, and contaminants on the compound tested preclinically that is intended foruse in clinical trials. The maximum allowable level of impurity in a stereoisomeric product employed inCLINICAL TRIALS SHOULD NOT EXCEED THAT PRESENT IN THE MATERIALEVALUATED IN NONCLINICAL toxicity studies.”FDA, DEVELOPMENT OF NEW STEREOISOMERIC DRUGS, PUBLICATION DATE: 5/1/92www.filab.com.pl
Page 1: Non-clinical Dose Formulation Analy
Page 4 and 5: Preclinical versus non-clinical& de
Page 6 and 7: Points for discussion1. Preclinical
Page 10 and 11: Final Formulation & Non-Clinical
Page 12 and 13: Identical / similar / comparable fo
Page 14 and 15: Role of polymorphism & technologica
Page 16 and 17: Preffered analytical methods method
Page 18 and 19: Resposibility for results of safety
Page 20 and 21: Chiral API & NCDFA„New drug subst
Page 22 and 23: FUTURE GUIDANCE & NCDFA High standa

Non-clinical Dose Formulation Analysis

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