-
1
-
-
84993736693
-
-
Drug, and Cosmetic Act (Public Law No. 75–717 52 Stat. 1040)
-
Federal Food, Drug, and Cosmetic Act (Public Law No. 75–717 52 Stat. 1040) 1938.
-
(1938)
-
-
-
5
-
-
0041557195
-
The impact of polymorphism on drug development—A regulator's point of view
-
DeCamp WH. The impact of polymorphism on drug development—A regulator's point of view. Am Pharm Rev. 2001; 4(3):70–77.
-
(2001)
Am Pharm Rev.
, vol.4
, Issue.3
, pp. 70-77
-
-
DeCamp, W.H.1
-
6
-
-
0345705351
-
-
London, UK: The Pharmaceutical Press
-
The Pharmaceutical Codex. Principles and Practices of Pharmaceutics. London, UK: The Pharmaceutical Press; 1994.
-
(1994)
Principles and Practices of Pharmaceutics
-
-
-
7
-
-
0345273791
-
The role of X-ray diffraction as a powerful tool in characterization of various hydrants of a drug substance
-
Davidovich M, Mueller R, Raghavan K, Ranadive S, Vitez I, Sarsfield B, DiMarco J, Gougoutas J, Newman A. The role of X-ray diffraction as a powerful tool in characterization of various hydrants of a drug substance. Am Pharm Rev. 2001; 4(1):53–60.
-
(2001)
Am Pharm Rev.
, vol.4
, Issue.1
, pp. 53-60
-
-
Davidovich, M.1
Mueller, R.2
Raghavan, K.3
Ranadive, S.4
Vitez, I.5
Sarsfield, B.6
DiMarco, J.7
Gougoutas, J.8
Newman, A.9
-
8
-
-
84993805322
-
-
(NF). USP 25, NF 20. Rockville, MD: United States Pharmacopeial Convention, Inc.; January
-
United States Pharmacopeial Convention, Inc. The United States Pharmacopeia (USP)/The National Formulary (NF). USP 25, NF 20. Rockville, MD: United States Pharmacopeial Convention, Inc.; January 2002.
-
(2002)
The United States Pharmacopeia (USP)/The National Formulary
-
-
-
9
-
-
84993765619
-
-
Geneva, Switzerland: International Conference on Harmonization; July
-
International Conference on Harmonization. Q3A (R): Impurities in New Drug Substances. Geneva, Switzerland: International Conference on Harmonization; July 2000.
-
(2000)
Q3A (R): Impurities in New Drug Substances
-
-
-
10
-
-
84993688014
-
-
Geneva, Switzerland: International Conference on Harmonization; July
-
International Conference on Harmonization. Q3B (R): Impurities in New Drug Products. Geneva, Switzerland: International Conference on Harmonization; July 2000.
-
(2000)
Q3B (R): Impurities in New Drug Products
-
-
-
11
-
-
84993805306
-
-
Geneva, Switzerland: International Conference on Harmonization; December
-
International Conference on Harmonization. Q3C: Impurities: Residual Solvents. Geneva, Switzerland: International Conference on Harmonization; December 1997.
-
(1997)
Q3C: Impurities: Residual Solvents
-
-
-
14
-
-
84993731621
-
-
Geneva, Switzerland: International Conference on Harmonization; April
-
International Conference on Harmonization. Q1A (R): Stability Testing of New Drug Substances and Products. Geneva, Switzerland: International Conference on Harmonization; April 2000.
-
(2000)
Q1A (R): Stability Testing of New Drug Substances and Products
-
-
-
15
-
-
84993792215
-
-
Geneva, Switzerland: International Conference on Harmonization; November
-
International Conference on Harmonization. Q1B: Photostability Testing of New Drug Substances and Products. Geneva, Switzerland: International Conference on Harmonization; November 1996.
-
(1996)
Q1B: Photostability Testing of New Drug Substances and Products
-
-
-
16
-
-
84993683987
-
-
Geneva, Switzerland: International Conference on Harmonization; May
-
International Conference on Harmonization. Q1C: Stability Testing of New Dosage Forms. Geneva, Switzerland: International Conference on Harmonization; May 1997.
-
(1997)
Q1C: Stability Testing of New Dosage Forms
-
-
-
20
-
-
0006302849
-
-
Rockville, MD: US Food and Drug Administration; February
-
US Food and Drug Administration. Guidance for Industry—INDs for Phase 2 and 3 Studies of Drugs, Including Well Characterized, Therapeutic, Biotechnology Derived Products, Chemistry, Manufacturing and Controls Content and Format. Rockville, MD: US Food and Drug Administration; February 1999.
-
(1999)
Guidance for Industry—INDs for Phase 2 and 3 Studies of Drugs, Including Well Characterized, Therapeutic, Biotechnology Derived Products, Chemistry, Manufacturing and Controls Content and Format
-
-
-
21
-
-
84993749081
-
-
21 CFR Part 312. Rockville, MD: US Food and Drug Administration; April
-
21 CFR Part 312. Investigational New Drug Application. Rockville, MD: US Food and Drug Administration; April 1994.
-
(1994)
Investigational New Drug Application
-
-
-
25
-
-
0344842360
-
-
Rockville, MD: US Food and Drug Administration; July
-
US Food and Drug Administration. Guidance for Industry—Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products—Chemistry, Manufacturing, and Controls Documentation. Rockville, MD: US Food and Drug Administration; July 2002.
-
(2002)
Guidance for Industry—Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products—Chemistry, Manufacturing, and Controls Documentation
-
-
-
27
-
-
0345705344
-
Methodical evaluation of OOS results—a problem solving approach
-
Gentry AE. Methodical evaluation of OOS results—a problem solving approach. Am Pharm Rev. 2001; 4(4):78–81.
-
(2001)
Am Pharm Rev.
, vol.4
, Issue.4
, pp. 78-81
-
-
Gentry, A.E.1
-
28
-
-
0345273786
-
Analytical Support for Pharmaceutical Manufacturing—Translating Regulations and Guidelines into Laboratory Operations
-
in: London, UK: Samedan Ltd. Pharmaceutical Publishing; March
-
Velagaleti R, Halliday J, Noland P. Analytical Support for Pharmaceutical Manufacturing—Translating Regulations and Guidelines into Laboratory Operations. In: Pharmaceutical Packaging and Manufacturing Sourcer. London, UK: Samedan Ltd. Pharmaceutical Publishing; March 1999.
-
(1999)
Pharmaceutical Packaging and Manufacturing Sourcer
-
-
Velagaleti, R.1
Halliday, J.2
Noland, P.3
-
31
-
-
0009872542
-
-
Rockville, MD: US Food and Drug Administration; November
-
US Food and Drug Administration. Guidance for Industry—Changes to the Approved NDA or ANDA. Rockville, MD: US Food and Drug Administration; November 1999.
-
(1999)
Guidance for Industry—Changes to the Approved NDA or ANDA
-
-
-
32
-
-
0003646348
-
-
Rockville, MD: US Food and Drug Administration; November
-
US Food and Drug Administration. Reviewer Guidance—Validation of Chromatographic Methods. Rockville, MD: US Food and Drug Administration; November 1994.
-
(1994)
Reviewer Guidance—Validation of Chromatographic Methods
-
-
-
33
-
-
0005731989
-
-
Ottawa, Canada: Health Protection Branch. Health and Welfare Canada; July
-
Health Protection Branch. Acceptable Methods. Drugs Directorate Guidelines. Ottawa, Canada: Health Protection Branch. Health and Welfare Canada; July 1992.
-
(1992)
Acceptable Methods. Drugs Directorate Guidelines
-
-
-
35
-
-
0029806819
-
The role of dissolution testing in the design of immediate release dosage forms
-
Storey DE. The role of dissolution testing in the design of immediate release dosage forms. Drug Inf J. 1996; 30: 1039–1044.
-
(1996)
Drug Inf J.
, vol.30
, pp. 1039-1044
-
-
Storey, D.E.1
-
38
-
-
0031933036
-
Validation of analytical methods in pharmaceutical cleaning assessment and validation
-
Supp
-
Kirsch RB. Validation of analytical methods in pharmaceutical cleaning assessment and validation. Pharma Tech Supp. 1998; 22: 40–45.
-
(1998)
Pharma Tech
, vol.22
, pp. 40-45
-
-
Kirsch, R.B.1
-
40
-
-
0001273922
-
-
21 CFR PART 11. Final Rule
-
Electronic Records and Electronic Signatures. 21 CFR PART 11. Final Rule. Federal Register. 1997; 62: 13430–13466.
-
(1997)
Federal Register
, vol.62
, pp. 13430-13466
-
-
|