Cardiovascular Journal of Africa: Vol 21 No 2 (March/April 2010) - page 9

CARDIOVASCULAR JOURNAL OF AFRICA • Vol 21, No 2, March/April 2010
AFRICA
71
References
CPMP.
1.
Note for Guidance on the Investigation of Bioavailability and
Bioequivalence
. London: Committee for Proprietary Medicinal Products,
2001.
Chow S-C, Liu JP.
2.
Design and Analysis of Bioavailability and
Bioequivalence Studies
, 3rd edn. Boca Raton: CRC Press, 2009.
Lindenbaum J, Mellow MH, Blackstone MO, Butler VP (jun). Variation
3.
in biologic availability of digoxin from four preparations.
N Engl J Med
1971;
285
: 1244–1347.
Schulz H-U, Steinijans VW. Striving for standards in bioequiva-
4.
lence assessment: a review.
Int J Clin Pharm Ther Toxicol
1991;
29
:
293–298.
Skelly KP, Knapp G. Biologic activity of digoxin tablets.
5.
J Am Med Ass
1973;
224
: 243.
FDA.
6.
Statistical Procedures for Bioequivalence Studies using a Standard
Two Treatment Cross-over Design
. Washington DC: FDA, CDER,
1992.
Anderson S, Hauck WW. Consideration of individual bioequivalence.
7.
J
Pharmacokinet Biopharm
1990;
18
: 259–273.
Schall R. A unified view of individual, population, and average
8.
bioequivalence. In: Blume HH, Midha KK, ed.
BIO-International 2.
Bioavailability, Bioequivalence and Pharmacokinetic Studies
. Stuttgart:
Medpharm Scientific, 1995: 91–106.
Hauschke D, Steinijans VW, Pigeot I.
9.
Bioequivalence Studies in Drug
Development. Methods and Applications
. Chichester: Wiley, 2007.
FDA.
10.
Statistical Approaches to Establishing Bioequivalence
. Guidance
for Industry. Washington DC: FDA, CDER, 2001.
/
cder/guidance/
Gould AL. A practical approach for evaluating population and individual
11.
bioequivalence.
Stat Med
, 2000;
19
: 2721–2740.
Barret JS, Batra V, Chow A, Cook J, Gould AL, Heller A,
12.
et al
.
PHARMA perspective on population and individual bioequivalence.
J
Clin Pharmacol
2000;
40
: 561–570
Patterson S. A review of the development of statistical design and
13.
analysis techniques for assessing in vivo bioequivalence: Part two.
Ind J
Pharm Sc
2001;
63
: 169–186.
FDA.
14.
Bioavailability and Bioequivalence Studies for OrallyAdministered
Drug Products – General considerations
. Guidance for Industry.
Washington DC: FDA, CDER, 2003.
-
ance/
Rheinstein PH. Therapeutic inequivalence.
15.
Drug Safety
1990;
5
(Suppl
1): 114–119.
Pollard S, Nashan B, Johnston A, Hoyer P, Belitsky P, Keown P,
16.
Helderman H. A pharmacokinetic and clinical review of the potential
clinical impact of using different formulations of cyclosporine A.
Clin
Ther
2003;
25
: 1654–1669.
Tothfalusi L, Endrenyi L, Arieta AG. Evaluation of bioequivalence
17.
for highly variable drugs with scaled average bioequivalence.
Clin
Pharmacokinet
2009;
48
: 725–743.
Haidar SH, Davit B, Chen M-L,
18.
et al
. Bioequivalence approaches
for highly variable drugs and drug products.
Pharm Res
2008;
25
:
237–241.
Sheiner LB. Bioequivalence revisited.
19.
Stat Med
1992;
11
: 1777–1788.
Schall R, Luus HG. On population and individual bioequivalence.
20.
Stat
Med
1993;
12
: 1109–1124.
CHMP.
21.
Guideline on the Investigation of Bioequivalence
. London:
Committee for Medicinal Products for Human Use, 2008.
emea.europa.eu/pdfs/human/qwp/140198enrev1fin.pdf
South African
Heart Association
First Announcement
For further information contact the Congress Office:
Sue McGuinness Communications & Event Management
Telephone: +27 (0)11 447 3876 • Fax: +27 (0)11 442 8094
Email:
Holistic Heart Care
SA Heart Congress 2010
Clinical & Interventional Cardiology
Enhancing your day to day care, expanding your horizons
8 –11 August
Sun City • South Africa
1,2,3,4,5,6,7,8 10,11,12,13,14,15,16,17,18,19,...64
Powered by FlippingBook