18 results on '"James Bernstein"'
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2. Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid
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Marquerita Algorri, Ajay Acharya, James Bernstein, Nina S. Cauchon, Xiao Hong Chen, Kim Huynh-Ba, Carol Krantz, Tao Li, Yiwei Li, Sherita McLamore, Scott W. Roberts, David Schwinke, Rakhi Shah, Andrea Schirmer, Helen Strickland, Kin Tang, and Timothy Watson
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Regulatory ,FDA ,Regulatory efficiency ,Accelerated review ,Chemistry, Manufacturing, and Controls ,Project Orbis ,Therapeutics. Pharmacology ,RM1-950 ,Pharmacy and materia medica ,RS1-441 - Abstract
Abstract The American Association of Pharmaceutical Scientists (AAPS) Chemistry, Manufacturing, and Controls (CMC) Community hosted two virtual panel discussions focusing on several novel regulatory review pathways for innovative oncology products: Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid (PQAAid). The panel sessions were held on August 27, 2021, for the discussion of RTOR, and January 21, 2022, for the discussion of Project Orbis and the PQAAid. Both panel sessions included representatives from the US Food and Drug Administration (FDA) and subject matter experts from the pharmaceutical and biotechnology industries, with the aim of facilitating knowledge sharing on CMC-specific advantages, challenges, eligibility criteria for participation, and operational modifications instituted through the utilization of these acceleration initiatives. Key topics included managing cross-regional regulatory CMC requirements, adapting to expedited development timelines, coordinating interactions between health authorities and industry, and potential opportunities for future improvement and expansion of these programs. As RTOR, Project Orbis, and PQAAid are relatively new initiatives, the experiences shared by the panel experts are valuable for providing deeper insight into these new regulatory pathways and processes.
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- 2022
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3. Credit procyclicality and financial regulation in South Africa
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James Bernstein, Leroi Raputsoana, and Eric Schaling
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Management. Industrial management ,HD28-70 ,Business ,HF5001-6182 ,Economics as a science ,HB71-74 - Abstract
This study assesses the behaviour of credit extension over the business cycle in South Africa for the period 2000 to 2012. This is motivated by the proposal of the Basel Committee on Banking Supervision to look at credit extension over the business cycle as a reference guide for implementing countercyclical capital buffers for financial institutions. The study finds that credit extension in South increases during the trough phase, while the relationship between credit extension and the business cycle becomes insignificant during the peak phase. The study also finds that credit extension decreases during the expansion phase, while it increases during the contraction phase. Thus we do not find any evidence of procyclical behaviour of credit extension in South Africa, and the latter should therefore be used with caution and not as a mechanical rule based common reference guide for countercyclical capital buffers for financial institutions.
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- 2016
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4. Meeting Report: N-Nitrosamine Impurity Control Strategies in the Pharmaceutical and Biotechnology Industries
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Cheenu Murti, Christine Nylund Kolz, Steve Cole, Ganapathy Mohan, Noreen Curristin, Kim Huynh-Ba, Andrew Lennard, K. Tang, James Bernstein, Nina Cauchon, and Scott W. Roberts
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Quality Control ,Societies, Pharmaceutical ,Nitrosamines ,United States Food and Drug Administration ,business.industry ,Control (management) ,Drug Master File ,Pharmaceutical Science ,Pharmacy ,Congresses as Topic ,United States ,Biotechnology ,Subject-matter expert ,Pharmaceutical Preparations ,Global health ,Business ,Dialog box ,Drug Contamination ,Risk assessment ,Panel discussion - Abstract
The American Association of Pharmaceutical Scientists (AAPS) Chemistry, Manufacturing, and Control (CMC) Community hosted a virtual panel discussion on December 9, 2020, to provide a forum to discuss N-nitrosamine control strategies in the pharmaceutical and biotechnology industries. The panel included staff from the US Food and Drug Administration (FDA) and industry subject matter experts. Meeting topics included acceptable intake levels for nitrosamine impurities, definitions of "acceptable level of risk," water as a contributor in nitrosamine risk assessments, nitrosamine impurity control strategies based upon fate/purge data, early vs. late development assessment expectations, application to oncology programs developed under ICH S9, and Drug Master File (DMF) regulatory expectations. During the meeting, divergence in global health authority expectations was additionally discussed. One of the most important outputs from this AAPS panel discussion was the criticality of continued dialog between industry and health authorities to help understand actual versus perceived risks and provide pragmatic, scientifically justified solutions to ensure patients are provided with an uninterrupted supply of safe medicines based on globally harmonized requirements.
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- 2021
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5. Credit Procyclicality and Financial Regulation in South Africa
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James Bernstein, Leroi Raputsoane and Eric Schaling
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jel:E61 ,jel:E32 ,jel:C32 ,jel:G21 ,Credit Procyclicality, Financial Regulation - Abstract
This study assesses the behaviour of credit extension over the economic cycle to determine its usefulness as a reference guide for implementing the countercyclical capital buffers for financial institutions in South Africa. The study finds that the common reference guide for implementing the countercyclical capital buffers, which is based on the gap between the ratio of aggregate private sector credit to gross domestic product and its long term trend, increases during the economic cycle busts, while such a relationship is broken during the economic cycle booms. The study also finds that this common reference guide decreases during the upturns in the economic cycle, while it increases during the periods of downturns in the economic cycle. Thus credit extension should be used with caution as a common reference guide to determine the level of the countercyclical capital buffers for financial institutions in South Africa.
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- 2014
6. Variations in hypertension control in indigent rural primary care clinics in North Carolina
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Adam O. Goldstein, Susan Madson, Denise Levis, James Bernstein, and Timothy S. Carey
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Adult ,Male ,medicine.medical_specialty ,Medical Indigency ,Angiotensin-Converting Enzyme Inhibitors ,Rural Health ,Primary care ,Chart review ,Health care ,North Carolina ,medicine ,Humans ,Diuretics ,Antihypertensive Agents ,Aged ,Retrospective Studies ,Chi-Square Distribution ,Primary Health Care ,Hypertension control ,biology ,business.industry ,Outcome measures ,Confounding Factors, Epidemiologic ,Angiotensin-converting enzyme ,Community Health Centers ,General Medicine ,Continuity of Patient Care ,Middle Aged ,Calcium Channel Blockers ,Treatment Outcome ,Blood pressure ,Sample size determination ,Family medicine ,Hypertension ,Emergency medicine ,biology.protein ,Patient Compliance ,Female ,business - Abstract
OBJECTIVE To examine blood pressure control and prescribing practices in the treatment of hypertension, including the use of sample medications, in rural populations. DESIGN Retrospective chart review of 296 hypertensive patients and surveys of primary care providers serving these patients. SETTING Twenty-seven rural, primary care clinics in North Carolina. OUTCOME MEASURE Blood pressure control, with the practice site as the unit of analysis. RESULTS An average of 29% of patients per clinic had blood pressures that were inadequately controlled. Wide variations existed between clinics in blood pressure control and medication costs. Thirty-two percent of all blood pressure medications used were either angiotensin converting enzyme inhibitors or calcium channel blockers compared with 26% use of diuretics. Virtually all clinics used sample antihypertensive agents and reported that sample medications were an important source of free medications for their indigent patients. Reported sample use by practice was positively correlated with the mean daily hypertensive medication costs. Variations in blood pressure control were not explained by any measured variables, although the sample size was small. CONCLUSIONS Large variations exist within rural North Carolina primary care clinics in blood pressure control and medication costs. We need to study further the relationships of new antihypertensive agents, medication costs, and sample use with blood pressure control, health care costs, and other patient outcomes.
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- 1994
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7. Development of a Model Quality-of-Care Assessment Program for Adult Preventive Care in Rural Medical Practices
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Timothy S. Carey, C. Glenn Pickard, Denise Levis, and James Bernstein
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Rural Population ,Medical Audit ,medicine.medical_specialty ,medicine.diagnostic_test ,Leadership and Management ,business.industry ,Psychological intervention ,Papanicolaou stain ,Pilot Projects ,Models, Theoretical ,Preventive care ,Feedback ,Test (assessment) ,Vaccination ,Outcome and Process Assessment, Health Care ,Family medicine ,North Carolina ,Medicine ,Model quality ,Forms and Records Control ,Preventive Medicine ,Pap test ,Practice Patterns, Physicians' ,business ,Adult health - Abstract
A four-year project of quality-of-care assessment for 37 practices in rural North Carolina used chart abstraction and formal feedback to practitioners to improve compliance standards for 13 adult health maintenance interventions. In 1987, performance of Papanicolaou (Pap) test within two years ranged from 20% to 100% (mean, 61%), mammogram 0% to 70% (mean, 20%), and influenza vaccination 0% to 90% (mean, 59%). Practices received individual results and remediation took place for those practices that performed poorly; a reaudit took place in 1989, with improvement in all measures for all practices, except the influenza vaccination. Compliance results for 1989 were 30% to 100% (mean, 67%) for the Pap test, 10% to 100% (mean, 40%) for the mammography screening, and 5% to 80% for the influenza vaccination. These results suggest that coordinated quality-of-care assessment for rural practices can be performed with a modest administrative burden and substantial benefit to the practices.
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- 1991
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8. The Treatment of an Extensively Damaged Oil Painting on Canvas
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James Bernstein
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Painting ,Oil painting ,media_common.quotation_subject ,Museology ,Conservation ,Art ,media_common ,Visual arts - Abstract
The treatment concerns the repair of a "Landscape with Figures", most probably painted by a northern European artist working in Italy during the first half of the eighteenth century. Abuse and neglect over the years had produced notable tears, planar distortions, paint losses, discoloration and deterioration throughout (see Fig. 1). As the painting was presented to the author as an expendable, it was possible to deviate from standard treatment procedures in order to find effective solutions for these problems. The methods used in the treatment, which proved highly successful, are described in the paper that follows.
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- 1974
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9. A Study of Michigan Farm Bureau's Publication: Rural Living
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Michael V. Doyle, Daniel T. Davis, and James Bernstein
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History ,Materials Science (miscellaneous) ,Media studies ,Socioeconomics - Published
- 1986
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10. 19720315 Metropolitan Mar 15 1972
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Mozell, Paul; Lebow, Jack; Sternberg, Robert; Rothman, Edward; Yenisey, Leyla; Rogers, David; Brody, Reed; Colby, Scott; Weber, Rich; Peto, Gail; Clair, Ira; Koplin, Russ; Goddett, Fred; Kuhl, Chris; Elkind, Jeff; Hancock, Don; Kanefsky, Steve; Stone, James; Bernstein, Sandy; Edwards, Dave; Wirths, Bob; Schultz, John; Holstein, H.; Riordan, Judy; Morris, Mike and Mozell, Paul; Lebow, Jack; Sternberg, Robert; Rothman, Edward; Yenisey, Leyla; Rogers, David; Brody, Reed; Colby, Scott; Weber, Rich; Peto, Gail; Clair, Ira; Koplin, Russ; Goddett, Fred; Kuhl, Chris; Elkind, Jeff; Hancock, Don; Kanefsky, Steve; Stone, James; Bernstein, Sandy; Edwards, Dave; Wirths, Bob; Schultz, John; Holstein, H.; Riordan, Judy; Morris, Mike
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Vol. 13, No. 21; Weekly edition. Items scanned from microfilm of varying quality--some editions are difficult to read, mostly from 1972-1974.
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- 1972
11. 19720412 Metropolitan Apr 12 1972
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Clair, Ira; Cohen, Mindy; Brody, Reed; Lebow, Jack; Sternberg, Robert; Colby, Scott; Rothman, Edward; Yenisey, Leyla; Rogers, David; Weber, Rich; Peto, Gail; Clair, Ira; Koplin, Russ; Godett, Fred; Kuhl, Chris; Elkind, Jeff; Hancock, Don; McFadden, Jack; Kanefsky, Steve; Stone, James; Bernstein, Sandy; Edwards, Dave; Schultz, John; Wirths, Bob; Perkins, Cheryl; Mendelsohn, Linda and Clair, Ira; Cohen, Mindy; Brody, Reed; Lebow, Jack; Sternberg, Robert; Colby, Scott; Rothman, Edward; Yenisey, Leyla; Rogers, David; Weber, Rich; Peto, Gail; Clair, Ira; Koplin, Russ; Godett, Fred; Kuhl, Chris; Elkind, Jeff; Hancock, Don; McFadden, Jack; Kanefsky, Steve; Stone, James; Bernstein, Sandy; Edwards, Dave; Schultz, John; Wirths, Bob; Perkins, Cheryl; Mendelsohn, Linda
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Vol. 13, No. 24; Weekly edition. Items scanned from microfilm of varying quality--some editions are difficult to read, mostly from 1972-1974.
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- 1972
12. 19720503 Metropolitan May 3 1972
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Sobecki, Eugene; Colby, Scott; Edwards, Dave; Holstein, Heidi; Hutt, Daniel; McFadden, Jack; Hancock, Don;Sternberg, Robert; Rothman, Edward; Yenisey, Leyla; Rogers, David; Weber, Rich; Peto, Gail; Clair, Ira; Godett, Fred; Kuhl, Chris; Elkind, Jeff; McFadden, Jack; Kanefsky, Steve; Stone, James; Bernstein, Sandy; Edwards, Dave; Schultz, John; Wirths, Bob; Perkins, Cheryl; Nuzzio, Don; Cohen, Mindy; Peterson, Fred; Strausmann, Jeff; Lebow, Jack; Gordon, Linda and Sobecki, Eugene; Colby, Scott; Edwards, Dave; Holstein, Heidi; Hutt, Daniel; McFadden, Jack; Hancock, Don;Sternberg, Robert; Rothman, Edward; Yenisey, Leyla; Rogers, David; Weber, Rich; Peto, Gail; Clair, Ira; Godett, Fred; Kuhl, Chris; Elkind, Jeff; McFadden, Jack; Kanefsky, Steve; Stone, James; Bernstein, Sandy; Edwards, Dave; Schultz, John; Wirths, Bob; Perkins, Cheryl; Nuzzio, Don; Cohen, Mindy; Peterson, Fred; Strausmann, Jeff; Lebow, Jack; Gordon, Linda
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Vol. 13, No. 27; Weekly edition. Items scanned from microfilm of varying quality--some editions are difficult to read, mostly from 1972-1974.
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- 1972
13. 19720405 Metropolitan Apr 5 1972
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Brody, Reed; Colby, Scott; Mendelsohn, Linda; Wenson, Paul; Sternberg, Robert; Rothman, Edward; Yenisey, Leyla; Rogers, David; Weber, Rich; Peto, Gail; Clair, Ira; Koplin, Russ; Godett, Fred; Kuhl, Chris; Elkind, Jeff; Hancock, Don; McFadden, Jack; Kanefsky, Steve; Stone, James; Bernstein, Sandy; Edwards, Dave; Schultz, John; Wirths, Bob; McKie, Hoppy and Brody, Reed; Colby, Scott; Mendelsohn, Linda; Wenson, Paul; Sternberg, Robert; Rothman, Edward; Yenisey, Leyla; Rogers, David; Weber, Rich; Peto, Gail; Clair, Ira; Koplin, Russ; Godett, Fred; Kuhl, Chris; Elkind, Jeff; Hancock, Don; McFadden, Jack; Kanefsky, Steve; Stone, James; Bernstein, Sandy; Edwards, Dave; Schultz, John; Wirths, Bob; McKie, Hoppy
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Vol. 13, No. 23; Weekly edition. Items scanned from microfilm of varying quality--some editions are difficult to read, mostly from 1972-1974.
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- 1972
14. 19720426 Metropolitan Apr 26 1972
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Jenkins, Jocelyn; Richmen, Allen; Koplin, Russ; Brody, Reed; Lebow, Jack; Sternberg, Robert; Rothman, Edward; Yenisey, Leyla; Rogers, David; Weber, Rich; Peto, Gail; Clair, Ira; Godett, Fred; Kuhl, Chris; Elkind, Jeff; Hancock, Don; McFadden, Jack; Kanefsky, Steve; Stone, James; Bernstein, Sandy; Edwards, Dave; Schultz, John; Wirths, Bob; Perkins, Cheryl; Nuzzio, Don; Cohen, Mindy; Peterson, Fred; Noonan, Peggy; Mendelsohn, Linda; Gordon, Linda and Jenkins, Jocelyn; Richmen, Allen; Koplin, Russ; Brody, Reed; Lebow, Jack; Sternberg, Robert; Rothman, Edward; Yenisey, Leyla; Rogers, David; Weber, Rich; Peto, Gail; Clair, Ira; Godett, Fred; Kuhl, Chris; Elkind, Jeff; Hancock, Don; McFadden, Jack; Kanefsky, Steve; Stone, James; Bernstein, Sandy; Edwards, Dave; Schultz, John; Wirths, Bob; Perkins, Cheryl; Nuzzio, Don; Cohen, Mindy; Peterson, Fred; Noonan, Peggy; Mendelsohn, Linda; Gordon, Linda
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Vol. 13, No. 26; Weekly edition. Items scanned from microfilm of varying quality--some editions are difficult to read, mostly from 1972-1974.
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- 1972
15. 19720301 Metropolitan Mar 1 1972
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Colby, Scott; Brody, Reed; Asarch, Steve; McFadden, Jack; Lebow, Jack; Sternberg, Robert; Rothman, Edward; Yenisey, Leyla; Weber, Rich; Peto, Gail; Kuhl, Chris; Godett, Fred; Clair, Ira; Elkind, Jeff; Hancock, Don; Kanefsky, Steve; Stone, James; Bernstein, Sandy; Edwards, Dave; Schultz, John; Wirths, Bob and Colby, Scott; Brody, Reed; Asarch, Steve; McFadden, Jack; Lebow, Jack; Sternberg, Robert; Rothman, Edward; Yenisey, Leyla; Weber, Rich; Peto, Gail; Kuhl, Chris; Godett, Fred; Clair, Ira; Elkind, Jeff; Hancock, Don; Kanefsky, Steve; Stone, James; Bernstein, Sandy; Edwards, Dave; Schultz, John; Wirths, Bob
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Vol. 13, No. 19; Weekly edition. Items scanned from microfilm of varying quality--some editions are difficult to read, mostly from 1972-1974.
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- 1972
16. 19720308 Metropolitan Mar 8 1972
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Brody, Reed; Koplin, Russell; Mozell, Paul; Yenisey, Leyla; Asarch, Steve; Goldstein, Jon; Lebow, Jack; Sternberg, Robert; Rothman, Edward; Rogers, David; Colby, Scott; Weber, Rich; Peto, Gail; Clair, Ira; Godett, Fred; Kuhl, Chris; Elkind, Jeff; Hancock, Don; Kanefsky, Steve; Stone, James; Bernstein, Sandy; Edwards, Dave; McFadden, Jack; Wirths, Bob; Wortman, Rich; Bruning, Ted and Brody, Reed; Koplin, Russell; Mozell, Paul; Yenisey, Leyla; Asarch, Steve; Goldstein, Jon; Lebow, Jack; Sternberg, Robert; Rothman, Edward; Rogers, David; Colby, Scott; Weber, Rich; Peto, Gail; Clair, Ira; Godett, Fred; Kuhl, Chris; Elkind, Jeff; Hancock, Don; Kanefsky, Steve; Stone, James; Bernstein, Sandy; Edwards, Dave; McFadden, Jack; Wirths, Bob; Wortman, Rich; Bruning, Ted
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Vol. 13, No. 20; Weekly edition. Items scanned from microfilm of varying quality--some editions are difficult to read, mostly from 1972-1974.
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- 1972
17. 19720419 Metropolitan Apr 19 1972
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Asarch, Steve; Goldstein, Jon; Colby, Scott; Hirschfield, Barry; Lebow, Jack; Moog, Florence; Sternberg, Robert; Rothman, Edward; Yenisey, Leyla; Rogers, David; Weber, Rich; Peto, Gail; Clair, Ira; Koplin, Russ; Godett, Fred; Kuhl, Chris; Elkind, Jeff; Hancock, Don; McFadden, Jack; Kanefsky, Steve; Stone, James; Bernstein, Sandy; Edwards, Dave; Schultz, John; Wirths, Bob; Perkins, Cheryl; Nuzzio, Don; Cohen, Mindy; Peterson, Fred; Imbeninato, Donna; Werner, Arnold; Soloway, Jerry and Asarch, Steve; Goldstein, Jon; Colby, Scott; Hirschfield, Barry; Lebow, Jack; Moog, Florence; Sternberg, Robert; Rothman, Edward; Yenisey, Leyla; Rogers, David; Weber, Rich; Peto, Gail; Clair, Ira; Koplin, Russ; Godett, Fred; Kuhl, Chris; Elkind, Jeff; Hancock, Don; McFadden, Jack; Kanefsky, Steve; Stone, James; Bernstein, Sandy; Edwards, Dave; Schultz, John; Wirths, Bob; Perkins, Cheryl; Nuzzio, Don; Cohen, Mindy; Peterson, Fred; Imbeninato, Donna; Werner, Arnold; Soloway, Jerry
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Vol. 13, No. 25; Weekly edition. Items scanned from microfilm of varying quality--some editions are difficult to read, mostly from 1972-1974.
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- 1972
18. 19720322 Metropolitan Mar 22 1972
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Soloway, Jerry; Braun, Steve; Perkins, Cheryl; Sternberg, Robert; Rothman, Edward; Yenisey, Leyla; Rogers, David; Brody, Reed; Colby, Scott; Weber, Rich; Peto, Gail; Clair, Ira; Koplin, Russ; Godett, Fred; Kuhl, Chris; Elkind, Jeff; Hancock, Don; McFadden, Jack; Kanefsky, Steve; Stone, James; Bernstein, Sandy; Edwards, Dave; Schultz, John; Wirths, Bob; Holstein, Heidi; Werner, Arnold and Soloway, Jerry; Braun, Steve; Perkins, Cheryl; Sternberg, Robert; Rothman, Edward; Yenisey, Leyla; Rogers, David; Brody, Reed; Colby, Scott; Weber, Rich; Peto, Gail; Clair, Ira; Koplin, Russ; Godett, Fred; Kuhl, Chris; Elkind, Jeff; Hancock, Don; McFadden, Jack; Kanefsky, Steve; Stone, James; Bernstein, Sandy; Edwards, Dave; Schultz, John; Wirths, Bob; Holstein, Heidi; Werner, Arnold
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Vol. 13, No. 22; Weekly edition. Items scanned from microfilm of varying quality--some editions are difficult to read, mostly from 1972-1974.
- Published
- 1972
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