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Pharmaceutical Technology

Volumn 29, Issue 9, 2005, Pages 64-80

Analytical method equivalency: An acceptable analytical practice

(6) Chambers, Don a Kelly, Gregg b Limentani, Giselle c Lister, Ashley d Lung, K Rick e Warner, Ed f

a MERCK RESEARCH LABORATORIES (United States)

b PFIZER INC (United States)

c GLAXOSMITHKLINE (United States)

d PURDUE PHARMA L P (United States)

e ASTRAZENECA (United Kingdom)

f Global Quality Services Analytical Sciences (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DATA REDUCTION; DRUG PRODUCTS PLANTS; METRIC SYSTEM; STATISTICAL METHODS; TECHNICAL PRESENTATIONS;

ACCEPTANCE CRITERIA; ANALYTICAL METHODS; MANUAL METHODS; VALIDATION CRITERIA;

DRUG PRODUCTS;

ANALYTIC METHOD; AUTOMATION; DRUG INDUSTRY; GOOD MANUFACTURING PRACTICE; REVIEW; VALIDATION PROCESS;

EID: 24644455881 PISSN: 15432521 EISSN: None Source Type: Journal
DOI: None Document Type: Review

Times cited : (38)

References (8)

1
- 24644457332
- International Conference on Harmonization
- ICH, Geneva, Switzerland, Oct. 27
- International Conference on Harmonization, Q2A: Harmonized Tripartite Guideline, Text on Validation of Analytical Procedures (ICH, Geneva, Switzerland, Oct. 27, 1994), p.1.
- (1994) Q2A: Harmonized Tripartite Guideline, Text on Validation of Analytical Procedures , pp. 1

2
- 4444245544
- General chapter 〈1010〉 'analytical data: Interpretation and treatment'
- US Pharmacopeia, "General Chapter 〈1010〉 'Analytical Data: Interpretation and Treatment,'" Pharma. Forum 30 (1), 236-263 (2004).
- (2004) Pharma. Forum , vol.30 , Issue.1 , pp. 236-263

3
- 0004204553
- Ellis Horwood LTD, New York, NY, 3d ed.
- J.C. Miller and J.N. Miller, Statistics for Analytical Chemistry (Ellis Horwood LTD, New York, NY, 3d ed., 1993), p. 55.
- (1993) Statistics for Analytical Chemistry , pp. 55
- Miller, J.C.¹ Miller, J.N.²

4
- 0003455049
- Marcel Dekker, New York, NY
- Shein-Chung Chow and Jen-Pei Liu, Design and Analysis of Bioavailability and Bioequivalence Studies (Marcel Dekker, New York, NY, 1992), p. 77.
- (1992) Design and Analysis of Bioavailability and Bioequivalence Studies , pp. 77
- Chow, S.-C.¹ Liu, J.-P.²

5
- 0023615056
- A comparison of the two one-sided test procedures and the power approach for assessing the equivalence of average bioavailability
- D. Schuirmann, "A Comparison of the Two One-Sided Test Procedures and the Power Approach for Assessing the Equivalence of Average Bioavailability," J. Pharmaco. Biopharm. 15, 657-680 (1987).
- (1987) J. Pharmaco. Biopharm. , vol.15 , pp. 657-680
- Schuirmann, D.¹

6
- 3843068651
- Statistical method for the determination of equivalence of automated test procedures
- K.R. Lung et al., "Statistical Method for the Determination of Equivalence of Automated Test Procedures," J. Automated Methods and Management in Chemistry 25 (6), 123-127 (2003).
- (2003) J. Automated Methods and Management in Chemistry , vol.25 , Issue.6 , pp. 123-127
- Lung, K.R.¹

7
- 11144236689
- Sample size considerations for assessing the equivalence of two process means
- J. Stein and N. Doganaksoy, "Sample Size Considerations for Assessing the Equivalence of Two Process Means," Qual. Engineer. 12 (1), 105-110 (1999-2000).
- (1999) Qual. Engineer. , vol.12 , Issue.1 , pp. 105-110
- Stein, J.¹ Doganaksoy, N.²

8
- 20444376571
- Beyond the t-test: Statistical equivalence testing for analytical scientists
- G.B. Limentani et al., "Beyond the t-Test: Statistical Equivalence Testing for Analytical Scientists," Anal. Chem. 77, 221A-226A (2005).
- (2005) Anal. Chem. , vol.77
- Limentani, G.B.¹

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.