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Home      Drug Development Consulting

DRUG DEVELOPMENT CONSULTING

Help our clients, especially the small drug development businesses or individuals, design and support nonclinical and early phase clinical development programs with an innovative and integrative strategy pertinent to the intended clinical indications.

Strategic Nonclinical Development

 

  • Nonclinical study design and management (both GLP and non-GLP regulated studies)
  • Nonclinical study protocol
  • Nonclinical study monitoring services
  • Review and interpretation of nonclinical data
  • Evaluation of GLP testing facilities  
  • Strategic regulatory development plans
  • Clinical dose selection based on nonclinical data
  • Preparation of nonclinical study reports
 

NONCLINICAL STUDY SERVICES

Our contracted nonclinical CRO is a GLP compliant laboratory, it has been inspected by the US FDA and has met all GLP regulatory requirements; all study data submitted to FDA have been accepted. All your nonclinical needs for drug development will be satisfied at one-stop shopping with best quality and reasonable cost.

 

  • Drug Discovery

-    Pharmacology Efficacy Models (in vitro and in vivo)

-    Plasma Biomarker Analysis

  • Pharmacodynamic

-    In vivomodels in both small and large animals

 

  • Safety Pharmacology

-    Central Nervous System

-    Cardiovascular System

-    Respiratory System

-     Renal/Urinary System

-    Gastrointestinal System

 

  • Toxicology

-     General Toxicology (single- and repeated-dose toxicity studies in micerats, rabbits, dogs, monkeys and others as required)

-    Genetic Toxicology ( Ames, chromosomal aberration and micronucleus assays)

-    Carcinogenesis (Rodent life-time bioassays and transgenic mice study)

-    Developmental and Reproductive Toxicology (Three segments)

-    Special Toxicity (Immunogenicity study, hemolysis test, topical and local toxicity tests)

 

  • Pharmacokinetics and Toxicokinetics

-    Drug Exposure (AUC)

-    PK and TK Parameters

-    Bioequivalence/Bioavailability

-    In vivo CYP Induction

-    Formulation Assessment

 

  • Pathology Services

-    Toxicological Pathology

-    Immunohistochemistry

-     Histomorphometry

 
 
K & D Pharmaceutical Consulting, LLC
 
 TEL:+1-301-331-0007    FAX:+1-301-865-0008    Email: info@ kanddpharmaconsulting.com
10110 Molecular Drive, Suite 318 Rockville, Maryland 20850 USA /10705 Dewey Way,New Market, MD 21774 USA

 
 2012  K & D Pharmaceutical Consulting, LLC/凯帝药业总汇 All rights reserved.