A biopharmaceutical classification-based Right-First-Time formulation approach to reduce human pharmacokinetic variability and project cycle time from First-In-Human to clinical Proof-Of-Concept

Pharmaceutical Development and Technology

Volumn 17, Issue 3, 2012, Pages 285-302

  Ku, M Sherry ^a   Dulin, Wendy ^a  

^a WYETH RESEARCH   (United States)

Author keywords

Bioavailability; Biopharmaceutics classification system (BCS); First in Human (FIH); Formulation; Investigational New Drug (IND) application

Indexed keywords

DILUENT; DISINTEGRATING AGENT; SOLUBILIZER; STABILIZING AGENT;

ARTICLE; BIOPHARMACEUTIC CLASSIFICATION SYSTEM; CONTROLLED RELEASE FORMULATION; DRUG BIOAVAILABILITY; DRUG CLASSIFICATION; DRUG FORMULATION; DRUG MANUFACTURE; DRUG PENETRATION; DRUG SOLUBILITY; DRUG STABILITY; FIRST IN HUMAN STUDY; FULL TIME EQUIVALENT; HUMAN; NONHUMAN; PARAMETERS; PHASE 1 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PROOF OF CONCEPT; TYPES OF STUDY;

DRUG APPROVAL; DRUG DESIGN; DRUG INDUSTRY; DRUG STABILITY; DRUGS, INVESTIGATIONAL; EXCIPIENTS; HUMANS; HYDROGEN-ION CONCENTRATION; PERMEABILITY; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS; SOLUBILITY; TIME FACTORS;

EID: 84859998651     PISSN: 10837450     EISSN: 10979867     Source Type: Journal    
DOI: 10.3109/10837450.2010.535826     Document Type: Article

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