| nr |
titel |
auteur |
tijdschrift |
jaar |
jaarg. |
afl. |
pagina('s) |
type |
| 1 |
Accelerating Availability of New Vaccines: The Role of the International Community
|
Milstien, Julie B.
|
|
|
32 |
1 |
p. 175-182
|
artikel
|
| 2 |
Adverse Drug Reactions: The Great Masqueraders
|
Routledge, P. A.
|
|
|
32 |
1 |
p. 79-84
|
artikel
|
| 3 |
An Analysis of Class I Recalls: 1982–1996
|
Rumore, Martha M.
|
|
|
32 |
1 |
p. 65-71
|
artikel
|
| 4 |
An Historical Perspective of the Successful Development of Sevoflurane
|
Callan, Clair
|
|
|
32 |
1 |
p. 119-127
|
artikel
|
| 5 |
Assessment of Generic Drugs in the Caribbean
|
Pereira, Lexley M. Pinto
|
|
|
32 |
1 |
p. 145-150
|
artikel
|
| 6 |
A Statistical Evaluation of the Chemical Composition of Heroin Samples with the View to Discriminating Between Their Possible Sources
|
Ekangaki, A.
|
|
|
32 |
1 |
p. 229-241
|
artikel
|
| 7 |
A Systems Infrastructure for Sponsor/CRO Collaboration on International Clinical Trials
|
Schoichet, Sandor
|
|
|
32 |
1 |
p. 155-161
|
artikel
|
| 8 |
Cancer Drug Development Problems and Opportunities
|
Markman, Maurie
|
|
|
32 |
1 |
p. 1-5
|
artikel
|
| 9 |
CDER/FDA Formats for Submission of Animal Carcinogenicity Study Data
|
Lin, Karl K.
|
|
|
32 |
1 |
p. 43-52
|
artikel
|
| 10 |
Changing the Review Process: The View of the Japanese Ministry of Health and Welfare
|
Hirayama, Yoshinobu
|
|
|
32 |
1 |
p. 111-117
|
artikel
|
| 11 |
Clinical Trials in Central/Eastern Europe: Industry Viewpoint
|
Natorff, Benona Lillian
|
|
|
32 |
1 |
p. 129-133
|
artikel
|
| 12 |
Detection of an Outlier and Evaluation of its Influence in Chronic Toxicity Studies
|
Hamada, Chikuma
|
|
|
32 |
1 |
p. 201-212
|
artikel
|
| 13 |
Development of ADR Monitoring Activities in Poland Subsequent to Changes in the Pharmaceutical Market
|
Czarnecki, Andrzej
|
|
|
32 |
1 |
p. 73-77
|
artikel
|
| 14 |
Drug Information Clerkships in the Pharmaceutical Industry
|
Fus, Andrea F.
|
|
|
32 |
1 |
p. 305-311
|
artikel
|
| 15 |
Drug Metabolism in Drug Development: A DIA Tutorial for Regulatory Affairs Specialists
|
Honig, Peter K.
|
|
|
32 |
1 |
p. 163-167
|
artikel
|
| 16 |
Eli Lilly and Company Global Medical Information: Pharmacy Student Clerkships in Industry
|
Riggins, Jennifer L.
|
|
|
32 |
1 |
p. 283-288
|
artikel
|
| 17 |
Expectations for an International Harmonized Guideline
|
Sato, Tosiya
|
|
|
32 |
1 |
p. 135-139
|
artikel
|
| 18 |
Faster Access to Drugs for Serious or Life-Threatening Illnesses Through use of the Accelerated Approval Regulation in the United States
|
Cocchetto, David M.
|
|
|
32 |
1 |
p. 27-35
|
artikel
|
| 19 |
Further Statistical Issues in Project Prioritization in the Pharmaceutical Industry
|
Senn, Stephen
|
|
|
32 |
1 |
p. 253-259
|
artikel
|
| 20 |
Impact of the Ich Guideline on Ethnic Differences
|
Dumitriu, Helene
|
|
|
32 |
1 |
p. 141-144
|
artikel
|
| 21 |
Interpretation of Subgroup Analyses in Medical Device Clinical Trials
|
Scott, Pamela E.
|
|
|
32 |
1 |
p. 213-220
|
artikel
|
| 22 |
Labeling of Drug and Biologic Products for Pediatric Use
|
Shacter, Emily
|
|
|
32 |
1 |
p. 299-303
|
artikel
|
| 23 |
Medical Information on Demand
|
Gaspic, Mary
|
|
|
32 |
1 |
p. 289-292
|
artikel
|
| 24 |
Orphan Drug Development—International Program and Study Design Issues
|
Haffner, Marlene E.
|
|
|
32 |
1 |
p. 93-99
|
artikel
|
| 25 |
Pharmacoeconomic Evaluation in Japanese Pharmaceutical Companies
|
Ikeda, Shunya
|
|
|
32 |
1 |
p. 169-174
|
artikel
|
| 26 |
Preparing an Integrated Summary of Safety: A Writer’s Perspective
|
Myers, Sharie
|
|
|
32 |
1 |
p. 53-63
|
artikel
|
| 27 |
Project Management in Pharmaceutical Biometry and Data Management: Conception, Implementation, and Operations
|
Wilhelm, Martin
|
|
|
32 |
1 |
p. 221-228
|
artikel
|
| 28 |
Proposed Statistical Methods for Signal Detection of Adverse Medical Device Events
|
Lao, Chang S.
|
|
|
32 |
1 |
p. 183-191
|
artikel
|
| 29 |
Quality Criteria and Standardization of Phytopharmaceuticals: Can Acceptable Drug Standards Be Achieved?
|
Bauer, Rudolf
|
|
|
32 |
1 |
p. 101-110
|
artikel
|
| 30 |
Sample Size Estimation when Comparing More than Two Treatment Groups
|
Phillips, Alan
|
|
|
32 |
1 |
p. 193-199
|
artikel
|
| 31 |
Statistics and Statisticians in European Drug Regulatory Agencies
|
Köpcke, Wolfgang
|
|
|
32 |
1 |
p. 243-251
|
artikel
|
| 32 |
Technologies for Automating Randomized Treatment Assignment in Clinical Trials
|
Haag, Uwe
|
|
|
32 |
1 |
p. 7-11
|
artikel
|
| 33 |
The Challenge of the Internet
|
Pines, Wayne L.
|
|
|
32 |
1 |
p. 277-281
|
artikel
|
| 34 |
The Drug Information Service at a University Hospital in Malaysia: Characteristics of Drug Inquiries
|
Rahman, Ab Fatah Ab
|
|
|
32 |
1 |
p. 293-298
|
artikel
|
| 35 |
The Emerging Role of Herbal Medicine in Health Care in Europe
|
Gruenwald, Joerg
|
|
|
32 |
1 |
p. 151-153
|
artikel
|
| 36 |
The Need for and Design of Combination Vaccines
|
Hausdorff, William P.
|
|
|
32 |
1 |
p. 13-17
|
artikel
|
| 37 |
Transfer of Processes from Development to Manufacturing
|
Gerson, Donald F.
|
|
|
32 |
1 |
p. 19-26
|
artikel
|
| 38 |
Understanding the Interfaces Among Multiple Technical Disciplines: An Increasing Challenge for Regulatory Affairs
|
Cocchetto, David M.
|
|
|
32 |
1 |
p. 37-41
|
artikel
|
| 39 |
Using Tolerance Limits to Evaluate Laboratory Data
|
Nickens, Dana J.
|
|
|
32 |
1 |
p. 261-269
|
artikel
|
| 40 |
What Does the Over-the-Counter Industry in Europe Need?
|
Cranz, Hubertus
|
|
|
32 |
1 |
p. 271-275
|
artikel
|
| 41 |
Working Methods for the Adverse Drug Reaction Monitoring Program in the Philippines
|
Hartigan-Go, Kenneth
|
|
|
32 |
1 |
p. 85-92
|
artikel
|
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