Pharmacokinetics, efficacy and toxicity of different pegylated liposomal doxorubicin formulations in preclinical models: Is a conventional bioequivalence approach sufficient to ensure therapeutic equivalence of pegylated liposomal doxorubicin products?

Cancer Chemotherapy and Pharmacology

Volumn 66, Issue 6, 2010, Pages 1173-1184

  Mamidi, Rao N V S ^a   Weng, Steve ^b,c   Stellar, Susan ^a   Wang, Charles ^a   Yu, Ning ^a   Huang, Tony ^b,d   Tonelli, Alfred P ^a   Kelley, Michael F ^a   Angiuoli, Anthony ^a   Fung, Man Cheong ^a  

^a JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

^b ALZA CORPORATION   (United States)

^c ELAN PHARMACEUTICALS   (United States)

^d Independent Formulation Consultant   (United States)

Author keywords

Antitumor activity; Bioequivalence; Generics; Pegylated liposomal doxorubicin (PLD); Pharmacokinetics; Toxicity

Indexed keywords

DOXORUBICIN; PLACEBO;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD TOXICITY; BONE MARROW; CONTROLLED STUDY; DISEASE SEVERITY; DISTRIBUTION VOLUME; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG ELIMINATION; DRUG EXPOSURE; DRUG FORMULATION; DRUG HALF LIFE; DRUG SAFETY; FEMALE; HUMAN; HUMAN CELL; KIDNEY TUBULE DISORDER; MALE; MAXIMUM PLASMA CONCENTRATION; MONKEY; MOUSE; MUSCLE ATROPHY; NONHUMAN; PRIORITY JOURNAL; SINGLE DRUG DOSE; SOLID TUMOR; SURVIVAL TIME; TIME TO MAXIMUM PLASMA CONCENTRATION; TOXICITY TESTING; TUMOR XENOGRAFT;

ANIMALS; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; BREAST NEOPLASMS; CHEMISTRY, PHARMACEUTICAL; DISEASE MODELS, ANIMAL; DOXORUBICIN; DRUG ADMINISTRATION SCHEDULE; FEMALE; HEART; HUMANS; MACACA FASCICULARIS; MICE; MICE, NUDE; POLYETHYLENE GLYCOLS; SURVIVAL ANALYSIS; THERAPEUTIC EQUIVALENCY; TRANSPLANTATION, HETEROLOGOUS; TREATMENT OUTCOME;

EID: 78149410814     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-010-1406-x     Document Type: Article

References (13)

1. DD Von Hoff MW Layard P Basa HL Davis Jr AL Von Hoff M Rozencweig FM Muggia 1979 Risk factors for doxorubicin-induced congestive heart failure Ann Intern Med 91 5 710 717
2. A Gabizon H Shmeeda Y Barenholz 2003 Pharmacokinetics of pegylated liposomal doxorubicin: review of animal and human studies Clin Pharmacokinet 42 5 419 436 1:CAS:528:DC%2BD3sXkvFOjsrY%3D 10.2165/00003088-200342050-00002 12739982 (Pubitemid 36649037)
3. DN Waterhouse PG Tardi LD Mayer MB Bally 2001 A comparison of liposomal formulations of doxorubicin with drug administered in free form Drug Safety 24 12 903 920 1:CAS:528:DC%2BD3MXptVyisrc%3D 10.2165/00002018-200124120-00004 11735647
4. ME O'Brien N Wigler M Inbar R Rosso E Grischke A Santoro R Catene DG Kieback P Tomczak SP Ackland F Orlandi L Mellars L Alland C Tendler 2004 Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX/Doxil) versus conventional doxorubicin for first-line treatment of metastatic breast cancer Ann Oncol 15 440 449 10.1093/annonc/mdh097 14998846 (Pubitemid 38444547)
5. Z Symon A Peyser D Tzemach E Lyass E Sucher E Shezen A Gabizon 1999 Selective delivery of doxorubicin to patients with breast carcinoma metastases by stealth liposomes Cancer 86 1 72 78 1:CAS:528:DyaK1MXktleqtLc%3D 10.1002/(SICI)1097-0142(19990701)86:1<72::AID-CNCR12>3.0.CO;2-1 10391566 (Pubitemid 29293379)
6. 2 Ann Oncol 11 1029 1033 1:STN:280:DC%2BD3cvoslOrsQ%3D%3D 10.1023/A:1008365716693 11038041
7. J Cui C Li W Guo Y Li C Wang L Zhang L Zhang Y Hao Y Wang 2007 Direct comparison of two pegylated liposomal doxorubicin formulations: is AUC predictive for toxicity and efficacy? J Control Release 118 204 215 1:CAS:528:DC%2BD2sXitlGhtL4%3D 10.1016/j.jconrel.2006.12.002 17239468 (Pubitemid 46350710)
8. DJ Holder F Hsuan R Dixit K Soper 1999 A method for estimating and testing area under the curve in serial sacrifice, batch, and complete data designs J Biopharm Stat 9 3 451 464 1:STN:280:DyaK1MvgtVSisg%3D%3D 10.1081/BIP-100101187 10473031 (Pubitemid 29395130)
9. D Davies T Morris 1993 Physiological parameters in laboratory animals and humans Pharm Res 10 7 1093 1095 1:STN:280:DyaK3szptFaqsg%3D%3D 10.1023/A:1018943613122 8378254 (Pubitemid 23211439)
10. Lasic DD (1993) Liposomes: from physics to applications. Elsevier Science Publishers, Amsterdam, pp 117-118
11. Torchilin VP, Papisov MI, Bogdanov AA, Trubetskoy VS, Omelyanenko VD (1995) Molecular mechanism of liposome and immunoliposome steric protection with poly(ethylene glycol): theoretical and experimental proofs of polymer chain flexibility. In: Lasic D, Martin F (eds) Stealth Liposomes CRC Press, pp 51-62
12. Liposome Drug Products (Draft guidance) (2002) Center for Drug Evaluation and Research, Food and Drug Administration. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm070570.pdf
13. Critical path opportunities for generic drugs (2007) Center for Drug Evaluation and Research, Food and Drug Administration. http://www.fda.gov/ ScienceResearch/SpecialTopics/CriticalPathInitiative/ CriticalPathOpportunitiesReports/ucm077250.htm#liposome