SCOPUS 정보 검색 플랫폼

Volumn 34, Issue 3, 2000, Pages 875-894

Regulatory implications of excipient changes in medicinal products

Author keywords

Biopharmaceutics Classification Scheme; Changes, International Pharmaceutical Excipients Council; Chemistry, Manufacturing, and Controls; Excipient; Functionality testing; Regulatory; Scale up Post Approval Changes; Variations

Indexed keywords

EXCIPIENT;

ARTICLE; DRUG APPROVAL; DRUG FORMULATION; LAW; MARKETING; PRIORITY JOURNAL; QUALITY CONTROL;

EID: 0033846980 PISSN: 00928615 EISSN: None Source Type: Journal
DOI: 10.1177/009286150003400324 Document Type: Article

Times cited : (14)

References (49)

1
- 0344621700
- The drug delivery system: Adding therapeutic and economic value to pharmaco-therapy
- 1997; Part II, 9(6): 58-66
- (1997) Pharma Tech Europe , vol.9 , Issue.5 PART 1 , pp. 36-40
- Sam, A.P.¹ Fokkens, J.G.²

2
- 0032580354
- Drug delivery and targeting
- (1998) Nature , vol.392 , Issue.SUPPL. , pp. 5-10
- Langer, R.¹

3
- 0008214494
- EU Guideline: Excipients in the dossier for application for marketing authorization of a medicinal product (3AQ9A)
- The Rules Governing Medicinal Products in the European Union. Luxembourg; EudraLex, Office for Official Publications of the European Union
- (1988) , vol.3 A , pp. 67-74

4
- 0008280031
- Notice to Applicants, The Rules Governing Medicinal Products in the European Union, Vol. 3A, Guidelines for Medicinal products for human use, Quality and biotechnology. Luxembourg; EudraLex, Office of Official Publications of the European Union
- (1998)

5
- 0001078132
- The influence of physical characteristics of excipients on the design and preparation of tablets and excipients
- (1977) Pharm Ind , vol.39 , Issue.5 , pp. 469-476
- Jones, T.M.¹

6
- 0008217397
- EU Guideline: Excipients in the label and package leaflet of medicinal products for human use (3BC7A)
- The Rules Governing Medicinal Products in the European Union. Luxembourg; EudraLex, Office of Official Publications of the European Union
- (1998) , vol.3 B , pp. 223-232

7
- 0008262432
- ICH Guideline: Stability testing of new drug substances and products (topic Q1A(R). Step 2. Geneva, Switzerland: International Conference on Harmonization
- (1999)

8
- 0008183596
- ICH Guideline: Specifications and acceptance criteria for new drug substances and new drug products: Chemical substances (topic Q6A). Geneva, Switzerland: International Conference on Harmonization
- (1999)

9
- 4244087230
- Drug delivery in the plastics age
- Innovations in drug delivery - Impact on Pharmacotherapy. Sam AP, Fokkens JG, eds. The Netherlands: Anselmus Foundation
- (1996)
- Heller, J.¹

10
- 0008223203
- Commission Regulations (EC) No 541/95 and 542/95 as amended by Commission Regulation (EC) 1146/98 and 1069/98 Further clarified by: A guideline on Dossier Requirements for Type I Variations. Brussels, Belgium: EC Commission
- (1999)

11
- 0008223816
- FDA Guidance for Industry: SUPAC-IR: Immediate Release Solid Oral Dosage Forms; Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing; In Vivo Bioequivalence. Federal Register. (230/30)
- (1995) , pp. 60

12
- 0008215954
- FDA Guidance for Industry: SUPAC-MR: Modified Release Solid Oral Dosage Forms, CMC, In Vitro dissolution testing, In Vivo Bioequivalence Documentation. Rockville, MD: U.S. Food and Drug Administration
- (1997)

13
- 0030572660
- Characterisation of the surface properties of α-lactose monohydrate with inverse gas chromatography, used to detect batch variation
- (1996) Int J Pharm , vol.141 , pp. 93-99
- Ticehurst, M.D.¹ York, P.² Rowe, R.C.³ Dwivedi, S.K.⁴

14
- 0027771859
- The batch-to-batch non-reproducibility of the compression ability of lactose. Reasons and detection
- (1993) S.T.P Pharma Sciences , vol.3 , Issue.6 , pp. 436-441
- Di Martino, P.¹ Martelli, S.² Guyot-Hermann, A.-M.³ Guyot, J.C.⁴ Conflant, P.⁵

15
- 0025063030
- Decomposition and stabilization of the tablet excipient calcium hydrogenphosphate dihydrate
- (1990) Drug Dev Ind Pharm , vol.16 , Issue.13 , pp. 2031-2055
- De Haan, P.¹ Kroon, C.² Sam, A.P.³

16
- 0028206808
- Particle size effects on the dehydration of dicalcium phosphate dihydrate powders
- (1994) Int J Pharm , vol.104 , pp. 271-275
- Landin, M.¹ Rowe, R.C.² York, P.³

17
- 0027246183
- Effect of batch variation and source of pulp on the properties of microcrystalline cellulose
- (1993) Int J Pharm , vol.91 , pp. 133-141
- Landin, M.¹ Martinez-Pacheco, R.² Gomez-Amoza, J.L.³ Souto, C.⁴ Concheiro, A.⁵ Rowe, R.C.⁶

18
- 0003157806
- Preparation and evaluation of lactide/glycolide copolymers for drug delivery
- Polymers in Medicine III. Migliaresi et al. eds. The Netherlands: Elsevier
- (1988) , pp. 149-160
- Dunn, R.L.¹ English, J.P.² Strobel, J.D.³ Cowsar, D.R.⁴ Tice, T.R.⁵

19
- 0027358998
- Interlot variability of carbomer 943
- (1993) Int J Pharm , vol.100 , pp. 207-212
- Perez-Marcos, B.¹ Marinez-Pacheco, R.² Gomez-Amoza, J.L.³ Souto, C.⁴ Concheiro, A.⁵ Rowe, R.C.⁶

20
- 0008178039
- IPEC-Americas guideline: Significant change guide for bulk pharmaceutical excipients. Rosslyn: International Pharmaceutical Excipients Council
- (2000)

21
- 0008177806
- FDA Guidance for Industry: BACPAC I: Intermediates in Drug Substance Synthesis - Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation. Rockville, MD: U.S. Food and Drug Administration
- (1998)

22
- 0008262784
- Excipients
- International Pharmaceutical product Registration - Aspects Of Quality, Efficacy And Safety. Cartwright AC, Matthews BR, eds. Chicester, England: Ellis Horwood
- (1994)
- Wotton, P.K.¹ Wade, G.² Moreton, R.C.³

23
- 4243678863
- Problems arising in connection with change of suppliers
- Excipients In Pharmaceutical Formulations - Regulatory And Scientific Requirements, Proceedings of the Arbeitsgemeinschaft fur Pharmazeutische Verfahrens Technik. Mainz, Germany, Symposium
- (1997)
- Mroz, C.¹

24
- 0008175195
- Code of Federal Regulations (Food and Drugs) 21 314.50 (d)(1)(ii), rev
- (1997)

25
- 0002393484
- An investigation of batch to batch variation of commercial magnesium stearates
- (1983) Proceedings 3rd Congress Technology and Pharmacy. Paris, France , vol.4 , pp. 72-80
- Hoelzer, A.W.¹

26
- 0020384667
- Batch variation of magnesium stearate and its effect on the dissolution rate of salicylic acid from solid dosage forms
- (1982) Drug Dev Ind Pharm , vol.8 , Issue.4 , pp. 497-511
- Billany, M.R.¹ Richards, J.H.²

27
- 0026117531
- Source variation in the wet massing (granulation) of some microcrystalline celluloses
- (1991) Powder Tech , vol.65 , pp. 273-281
- Parker, M.D.¹ Rowe, R.C.²

28
- 0027253630
- Influence of microcrystalline cellulose source and batch variation on the tabletting behaviour and stability of prednisone formulations
- (1993) Int J Pharm , vol.91 , pp. 143-149
- Landin, M.¹ Martinez-Pacheco, R.² Gomez-Amoza, J.L.³ Souto, C.⁴ Concheiro, A.⁵ Rowe, R.C.⁶

29
- 0028091304
- The effect of batch and source variation on the crystallinity of microcrystalline cellulose
- (1994) Int J Pharm , vol.101 , pp. 169-172
- Rowe, R.C.¹ McKillop, A.G.² Bray, D.³

30
- 0024821463
- Effects of variations in physicochemical properties of glyceryl monostearate on the stability of an oil-in-water cream
- (1989) J Soc Cosmet Chem , vol.40 , pp. 215-229
- O'Laughlin, R.¹ Sachs, C.² Brittain, H.³ Cohen, E.⁴ Timrains, P.⁵ Varia, S.⁶

31
- 0024339997
- Gel-matrix systems exhibiting bimodal controlled release for oral drug delivery
- (1989) J Control Release , vol.9 , pp. 169-175
- Shah, A.¹ Britten, N.J.² Olanoff, L.S.³ Badalamenti, J.N.⁴

32
- 0028114630
- Disintegration efficiency of sodium starch glycolates, prepared from different native starches
- (1994) Eur J Pharm Biopharm , vol.40 , Issue.5 , pp. 317-320
- Bolhuis, G.¹ Arends-Scholte, A.W.² Stuut, G.J.³ De Vries, J.A.⁴

33
- 0008261348
- Guideline Dry Powder Inhalers (CPMP/QWP/158/96 24-June-1998). London, UK: Committee for Proprietary Medicines
- (1997)

34
- 84961244405
- The Biopharmaceutics Classification System: Highlights of the FDA's draft guidance
- (1999) Diss Techn , vol.6 , Issue.2 , pp. 5-9
- Hussain, A.S.¹ Lesko, L.J.² Lo, K.Y.³ Shah, V.P.⁴ Volpe, D.⁵ Williams, R.L.⁶

35
- 0023882740
- The evaluation of six lactose-based materials as direct compression tablet excipients
- (1988) Drug Dev Ind Pharm , vol.14 , Issue.8 , pp. 1023-1040
- Whiteman, M.¹ Yarwood, R.J.²

36
- 0008261349
- Type II Complex Variation Definitions, Appendix 3 to Special MAIL 'New system for additional category of variations,' (Medicines Act Leaflet) London UK
- (1995)

37
- 0008262786
- FDA Draft guidance for industry: Food-Effect Bioavailability and Bioequivalence Studies. Rockville, MD: U.S. Food and Drug Administration, Center for Drug Evaluation and Research
- (1997)

38
- 0008176674
- Filler/binders in wet granulation, AVEBE Pharmaflash. Veendam, The Netherlands
- Kuiphuis, T.¹ Arends-Scholte, A.W.² Gruben-Rutgers, K.L.³

39
- 0025736029
- An investigation on the effect of high speed mixing on the mechanical and physical properties of direct compression lactose
- (1991) Drug Dev Ind Pharm , vol.17 , Issue.4 , pp. 503-517
- Thwaites, P.M.¹ Mashadi, A.B.² Moore, W.D.³

40
- 0008220379
- (transcript): Meeting of the Advisory Committee for Pharmaceutical Science, FDA, CDER. 13-23
- (1997)
- Hussain, A.¹

41
- 0029849092
- A new approach to the safety assessment of pharmaceutical excipients
- (1996) Reg Toxicol Pharmacol , vol.24 , pp. 149-154
- Steinberg, M.¹ Borzelleca, J.F.² Enters, E.K.³ Kinoshita, F.K.⁴ Loper, A.⁵ Mitchell, D.B.⁶ Tamulinas, C.B.⁷ Weiner, M.L.⁸

42
- 0028936843
- Acute toxicity and depression of the phagocytosis in vivo by liposomes: Influence of lysophosphotidylcholine
- (1995) Life Sci , vol.56 , pp. 99-106
- Lutz, J.¹ Augustin, A.J.² Brandl, D.³

43
- 0030042421
- Adverse events related to dosage forms and delivery systems
- (1996) Drug Safety , vol.14 , pp. 39-67
- Uchegbu, I.F.¹ Florence, A.T.²

44
- 0008260022
- note
- (1999) Official Journal of the European Communities , pp. 7-8

45
- 0008214497
- Committee for Proprietary Medicinal Products. Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products. CPMP/BWP/1230/98. London: Committee for Proprietary Medicinal Products
- (1999)

46
- 0008176675
- Council of Europe. Public Health Committee (Partial Agreement). Resolution AP-CSP (99) 5. Strasbourg, France
- (1999)

47
- 0008176904
- note
- (1999)

48
- 0008214722
- Council of Europe. Public Health Committee (Partial Agreement). Resolution AP-CSP (99) 4. Certification of suitability to the monographs of the European Pharmacopoeia (revised version). Strasbourg, France
- (1999)

49
- 0008280034
- U.S. Food and Drug Administration. FDA Guidance for Industry: Changes to an approved NDA or ANDA. Rockville, MD: U.S. Food and Drug Administration
- (1999)

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.