Paper Search Console

Home Search Page About Contact

Journal Title

Title of Journal: Pharm Res

Search In Journal Title:

Abbravation: Pharmaceutical Research

Search In Journal Abbravation:

Publisher

Springer US

Search In Publisher:

DOI

10.1002/adsc.200390064

Search In DOI:

ISSN

1573-904X

Search In ISSN:
Search In Title Of Papers:

Best Practices for Extractables and Leachables in

Authors: Daniel L Norwood Diane Paskiet Michael Ruberto Thomas Feinberg Alan Schroeder Guirag Poochikian Qingxi Wang Tian Jing Deng Fran DeGrazio Melinda K Munos Lee M Nagao
Publish Date: 2008/01/09
Volume: 25, Issue: 4, Pages: 727-739
PDF Link

Abstract

The Product Quality Research Institute Leachables and Extractables Working Group includes pharmaceutical development scientists representing industry government and academia The Working Group was created and constituted to address scientific and regulatory questions concerning the pharmaceutical development process for Orally Inhaled and Nasal Drug Products OINDP related to organic extractables and leachables This effort has resulted in the creation of a detailed “Recommendation Document” which was submitted to the US FDA for consideration in September 2006 The recommendations include proposed safety and analytical thresholds for leachables and extractables as well as detailed “best practice” recommendations for various aspects of the OINDP pharmaceutical development process including materials selection for OINDP container closure system components Controlled Extraction Studies Leachables Studies and Routine Extractables Testing The Working Group’s processes and the detailed and comprehensive recommendations that resulted from those processes demonstrate that the Product Quality Research Institute collaborative process can result in consensus sciencebased and data driven recommendations that could have a positive effect on patient care It is anticipated that the Working Group’s recommendations will also contribute to the new “Quality by Design” pharmaceutical development paradigm This commentary summarizes the best practice recommendations within the context of an overall pharmaceutical development processThe authors thank the members of the PQRI Leachables and Extractables Working Group for their hard work and commitment in developing the Recommendations and the PQRI Steering Committee PQRI Drug Product Technical Committee and the IPACRS Board of Directors for support of this work

Keywords:

References

.
Search In Abstract Of Papers:
Other Papers In This Journal:
  1. Decline in Exogenous Gene Expression in Primate Brain Following Intravenous Administration Is Due to Plasmid Degradation
  2. Tumor Environment Changed by Combretastatin Derivative (Cderiv) Pretreatment That Leads to Effective Tumor Targeting, MRI Studies, and Antitumor Activity of Polymeric Micelle Carrier Systems
  3. Measurement of Drug in Small Particles from Aqueous Nasal Sprays by Andersen Cascade Impactor
  4. Breast Cancer Resistance Protein-Mediated Efflux of Luteolin Glucuronides in HeLa Cells Overexpressing UDP-Glucuronosyltransferase 1A9
  5. Characterization of a Microsphere Formulation Containing Glucose Oxidase and its In Vivo Efficacy in a Murine Solid Tumor Model
  6. Versatile Methodology to Encapsulate Gold Nanoparticles in PLGA Nanoparticles Obtained by Nano-Emulsion Templating
  7. Chemical Drug Stability in Lipids, Modified Lipids, and Polyethylene Oxide-Containing Formulations
  8. PEGylated Interferon-α2b: A Branched 40K Polyethylene Glycol Derivative
  9. Crystal Structure Changes of γ -cyclodextrin After the SEDS Process in Supercritical Carbon Dioxide Affect the Dissolution Rate of Complexed Budesonide
  10. HCV J6/JFH1 Tilts the Capability of Myeloid-Derived Dendritic Cells to Favor the Induction of Immunosuppression and Th17-Related Inflammatory Cytokines
  11. Application of Clinical Trial Simulation to Compare Proof-of-Concept Study Designs for Drugs with a Slow Onset of Effect; An Example in Alzheimer's Disease
  12. Reservoir Based Fentanyl Transdermal Drug Delivery Systems: Effect of Patch Age on Drug Release and Skin Permeation
  13. Micellar Nanocarriers: Potential Nose-to-Brain Delivery of Zolmitriptan as Novel Migraine Therapy
  14. Targeted Delivery of Complexes of Biotin–PEG–Polyethylenimine and NF-κB Decoys to Brain-derived Endothelial Cells in Vitro
  15. Targeting, Endocytosis, and Lysosomal Delivery of Active Enzymes to Model Human Neurons by ICAM-1-Targeted Nanocarriers
  16. Targeted Delivery for Musculoskeletal Diseases
  17. Use of Partial AUC (PAUC) to Evaluate Bioequivalence—A Case Study with Complex Absorption: Methylphenidate
  18. Pegylated Nanocapsules Produced by an Organic Solvent-Free Method: Evaluation of their Stealth Properties
  19. PEGylation of Octreotide: II. Effect of N-terminal Mono-PEGylation on Biological Activity and Pharmacokinetics
  20. Human Nail Plate Modifications Induced by Onychomycosis: Implications for Topical Therapy
  21. Global Gene Expression Profiling in Cultured Cells Is Strongly Influenced by Treatment with siRNA–Cationic Liposome Complexes
  22. Combination Therapy of Antiandrogen and XIAP Inhibitor for Treating Advanced Prostate Cancer
  23. High Sensitivity Differential Scanning Calorimetry Study of DNA-Cationic Liposome Complexes
  24. Application of Dissolution/Permeation System for Evaluation of Formulation Effect on Oral Absorption of Poorly Water-Soluble Drugs in Drug Development
  25. The Effect of Polymeric Excipients on the Physical Properties and Performance of Amorphous Dispersions: Part I, Free Volume and Glass Transition
  26. Cationic Liposomal Co-delivery of Small Interfering RNA and a MEK Inhibitor for Enhanced Anticancer Efficacy
  27. Multiple Inhibition Mechanisms and Prediction of Drug–Drug Interactions: Status of Metabolism and Transporter Models as Exemplified by Gemfibrozil–Drug Interactions
  28. ATR/Raman and Fractal Characterization of HPBCD/Progesterone Complex Solid Particles
  29. Intermolecular Interactions and the Viscosity of Highly Concentrated Monoclonal Antibody Solutions
  30. Exploring the Wnt Pathway-Associated LncRNAs and Genes Involved in Pancreatic Carcinogenesis Driven by Tp53 Mutation
  31. Utility of Hydroxypropylmethylcellulose Acetate Succinate (HPMCAS) for Initiation and Maintenance of Drug Supersaturation in the GI Milieu
  32. Novel Inhibitors of Human Organic Cation/Carnitine Transporter (hOCTN2) via Computational Modeling and In Vitro Testing
  33. The Effect of Molecular Weight, Drug Load, and Charge of Gelatin–MTX Conjugates on Growth Inhibition of HL-60 Leukemia Cells
  34. Microstructure of Tablet—Pharmaceutical Significance, Assessment, and Engineering
  35. Preclinical Studies of Pegylated- and Non-Pegylated Liposomal Forms of Doxorubicin as Radiosensitizer on Orthotopic High-Grade Glioma Xenografts
  36. Star-Shaped Tetraspermine Enhances Cellular Uptake and Cytotoxicity of T-Oligo in Prostate Cancer Cells
  37. Pharmacokinetic and Pharmacodynamic Modeling of Opioid-Induced Gastrointestinal Side Effects in Patients Receiving Tapentadol IR and Oxycodone IR
  38. Micellar Delivery of Bicalutamide and Embelin for Treating Prostate Cancer
  39. Biodistribution and Efficacy of Low Temperature-Sensitive Liposome Encapsulated Docetaxel Combined with Mild Hyperthermia in a Mouse Model of Prostate Cancer
  40. Cellular Entry of G3.5 Poly (amido amine) Dendrimers by Clathrin- and Dynamin-Dependent Endocytosis Promotes Tight Junctional Opening in Intestinal Epithelia
  41. Polyplex Micelles from Triblock Copolymers Composed of Tandemly Aligned Segments with Biocompatible, Endosomal Escaping, and DNA-Condensing Functions for Systemic Gene Delivery to Pancreatic Tumor Tissue
  42. A Novel Method for Determining the Solubility of Small Molecules in Aqueous Media and Polymer Solvent Systems Using Solution Calorimetry
  43. Nanoparticulate Impurities in Pharmaceutical-Grade Sugars and their Interference with Light Scattering-Based Analysis of Protein Formulations
  44. Screening of Chemical Penetration Enhancers for Transdermal Drug Delivery Using Electrical Resistance of Skin
  45. Vitamin D 3 –Based Conjugates for Topical Treatment of Psoriasis: Synthesis, Antiproliferative Activity, and Cutaneous Penetration Studies
  46. The Effects of Food on the Dissolution of Poorly Soluble Drugs in Human and in Model Small Intestinal Fluids
  47. A Semi-mechanistic Modeling Strategy for Characterization of Regional Absorption Properties and Prospective Prediction of Plasma Concentrations Following Administration of New Modified Release Formulations
  48. A Semi-mechanistic Modeling Strategy for Characterization of Regional Absorption Properties and Prospective Prediction of Plasma Concentrations Following Administration of New Modified Release Formulations
  49. The BCS, BDDCS, and Regulatory Guidances
  50. Hydroxylation of R (+)- and S (−)-Omeprazole after Racemic Dosing are Different among the CYP2C19 Genotypes
  51. Physical Characterization and Innate Immunogenicity of Aggregated Intravenous Immunoglobulin (IGIV) in an In Vitro Cell-Based Model
  52. Targeted High Lung Concentrations of Itraconazole Using Nebulized Dispersions in a Murine Model
  53. Introduction of the Electrical Next Generation Impactor (eNGI) and Investigation of its Capabilities for the Study of Pressurized Metered Dose Inhalers
  54. Evaluation of Osteoclastogenesis via NFκB Decoy/mannosylated Cationic Liposome-Mediated Inhibition of Pro-inflammatory Cytokine Production from Primary Cultured Macrophages
  55. The Relation Between Granule Size, Granule Stickiness, and Torque in the High-Shear Granulation Process
  56. Curcumin Inhibits the Activity of ABCG2/BCRP1, a Multidrug Resistance-Linked ABC Drug Transporter in Mice
  57. Effect of Polymer Additives on the Transformation of BMS-566394 Anhydrate to the Dihydrate Form
  58. Microneedle-Based Transcutaneous Immunisation in Mice with N-Trimethyl Chitosan Adjuvanted Diphtheria Toxoid Formulations
  59. Triggered In Situ Drug Supersaturation and Hydrophilic Matrix Self-Assembly
  60. A Critical Evaluation of T m(FTIR) Measurements of High-Concentration IgG 1 Antibody Formulations as a Formulation Development Tool
  61. Amphotericin B-Gum Arabic Conjugates: Synthesis, Toxicity, Bioavailability, and Activities Against Leishmania and Fungi
  62. Targeted Delivery to Neuroblastoma of Novel siRNA-anti-GD2-liposomes Prepared by Dual Asymmetric Centrifugation and Sterol-Based Post-Insertion Method
  63. The Influence of Iontophoresis on Acyclovir Transport and Accumulation in Rabbit Ear Skin
  64. Predicting Mouse Liver Microsomal Stability with “Pruned” Machine Learning Models and Public Data
  65. Influenza T-cell Epitope-Loaded Virosomes Adjuvanted with CpG as a Potential Influenza Vaccine
Search Result: