This is a list of all the questions and their associated study carrel identifiers. One can learn a lot of the "aboutness" of a text simply by reading the questions.
| identifier | question |
|---|---|
| cord-017413-ymo9h7wb | Relevance of triple CGG repeats in the FMR1 gene to ovarian reserve Can egg donor selection be improved? |
| cord-022053-idft1p6d | U.S. adults Pertussis: microbiology, disease, treatment, and prevention Laboratory diagnosis of bacterial gastroenteritis Molecular testing for viral and bacterial enteric pathogens: gold standard for viruses, but do n't let culture go just yet? |
| cord-018566-dd5gw66t | The landscape of antibiotic resistance Prepared for United States Department of Health and Human Services, Public Health Service, Food and Drug Administration, Bureau of Veterinary Medicine Prudent use and regulatory guidelines for veterinary antibiotics- politics or science? |
| cord-278174-znc99yos | Is a recalled unit of plasma being thawed in the waterbath? |
| cord-308284-r546ypur | The question then arose: How many lives would have been saved if effective medical countermeasures had been made available sooner? |
| cord-269975-1ebmq7t8 | Is in vitro antibiotic combination more effective than single- drug therapy against anthrax? |
| cord-026653-094bk0t0 | The relevance of tick bites to the production of IgE antibodies to the mammalian oligosaccharide galactose- α-1,3-galactose Alpha- Gal in therapeutics: more relevant than thought? |
| cord-033420-pjtyv0pv | -What's in that Contract? |
| cord-291626-lxa8pvt3 | key: cord-291626-lxa8pvt3 authors: Pelfrene, E.; Mura, M.; Cavaleiro Sanches, A.; Cavaleri, M. title: Monoclonal antibodies as anti- infective products: a promising future? |
| cord-304056-2bo0s0hz | Finally, the next important phase for SADC is the implementation of the agreed- upon standards, recommendations, and plans( e.g., How will the proposed actions to"strengthen national DRA capacity to implement harmonized SADC guidelines"be managed?). |
| cord-328471-oz99upzz | The pharmacology of ornipressin( POR-8): a local vasoconstrictor used in surgery Ornipressin in the treatment of functional renal failure in decompensated liver cirrhosis: effects on renal hemodynamics and atrial natriuretic factor Management of preterm labor: atosiban or nifedipine? |
| cord-276460-nmugz0oh | The blood donor screening questionnaire: Is it effective? |
| cord-276460-nmugz0oh | To what extent does the observed increased deferral of donors admitting to high- risk behavior by CASI actually protect blood safety? |
| cord-256852-lrz17bdx | Could and should WHO be the lead organization in curbing the spreading epidemic of falsified pharmaceuticals? |
| cord-256852-lrz17bdx | How would the convention work and what national benefits would it bring? |
| cord-001513-p7v5p036 | This statement is not clear, does it mean that the others have progressed beyond the mouse EBOV model? |
| cord-001513-p7v5p036 | Would it be possible to explore for surface patches with similar physico- chemical features? |
| cord-001513-p7v5p036 | for this case? |
| cord-299323-riotkgj4 | An Implementation Guide Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmacueticals? |
| cord-299323-riotkgj4 | What are the implications of this difference? |
| cord-299323-riotkgj4 | What is a Package Leaflet-How to review it? |
| cord-273099-zkk5d6gd | Immunizations in the United States: success, structure, and stress The vaccine industry: does it need a shot in the arm? |
| cord-273099-zkk5d6gd | Which of the following is the process by which vaccines protect not only those who receive them but also those who can not or do not receive the vaccine? |
| cord-273099-zkk5d6gd | Why are pharmaceutical companies gradually abandoning vaccines? |
| cord-332038-icyut3xa | An updated overview and pharmacotherapeutics Mers: South Korea closes 700 schools after third death Severe respiratory disease associated with Middle East respiratory syndrome coronavirus Interaction of ethambutol with human organic cation transporters of the SLC22 family indicates potential for drug- drug interactions during antituberculosis therapy Screening of an FDA- approved compound library identifies four small- molecule inhibitors of Middle East respiratory syndrome corona virus replication in cell culture Effects of chloroquine on viral infections: an old drug against today's diseases? |
| cord-332038-icyut3xa | The renin- angiotensin system and antihypertensive drugs in Alzheimer's disease: Current standing of the angiotensin hypothesis? |
| cord-332038-icyut3xa | Time to share evidence and decision- making with patients? |
| cord-280571-ntgt5hy9 | : how can we test a test? |
| cord-280571-ntgt5hy9 | Why diagnose influenza in hospitalized pediatric patients? |
| cord-280571-ntgt5hy9 | hype or hope? |
| cord-333732-dtfmcqh6 | BALANCING Act: Safety, Innovation, and Resources in the Implementation of Medical Device Legislation, 12 Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of Whose Liberty? |
| cord-333732-dtfmcqh6 | Whose Security? |
| cord-333732-dtfmcqh6 | Window of Opportunity or Invitation for Recklessness? |
| cord-335776-e5wjsk8t | However, if a medication is not as effective or causes adverse reactions that result in hospitalizations is it really providing value for the cost? |
| cord-335776-e5wjsk8t | One question a pharmacist might ask is,"Will the patient receive the same medication( i.e., brand or generic) in an inpatient versus outpatient setting?" |
| cord-335776-e5wjsk8t | Rx: Exposing the Risks of America's Dependence on China for Medicine Bottle of Lies: The Inside Story of the Generic Drug Boom? |
| cord-322915-zrjx31ev | : where did we go wrong? |
| cord-322915-zrjx31ev | The end of an era? |
| cord-322915-zrjx31ev | The future of cephalosporins business Infectious history Oceans: medicine chests of the future? |
| cord-322915-zrjx31ev | Where have all the antibiotic patents gone? |
| cord-269194-b1wlr3t7 | Are treatment options available? |
| cord-269194-b1wlr3t7 | For how long will the patient need to be on therapy? |
| cord-269194-b1wlr3t7 | Simple amplification- based assay: A nucleic acid- based point- of- care platform for HIV-1 testing HIV-1 viral load blips are of limited clinical significance HIV cure and eradication: How will we get from the laboratory to effective clinical trials? |
| cord-269194-b1wlr3t7 | Transducers Quantitation of mRNA by the polymerase chain reaction Prehistoric eye disease( trachoma?) |
| cord-269194-b1wlr3t7 | What treatment regimen should be prescribed? |
| cord-002626-jzwwses4 | : does it improve clinical outcome? |
| cord-002626-jzwwses4 | A randomized controlled trial Early diagnosis of human cytomegalovirus disease in transplant recipients by DNA amplification in plasma Clinical utility of viral load in management of cytomegalovirus infection after solid organ transplantation Interpreting quantitative cytomegalovirus DNA testing: understanding the laboratory perspective Cytomegalovirus in hematopoietic stem cell transplant recipients Cytomegalovirus quantification: where to next in optimising patient management? |
| cord-002626-jzwwses4 | Busulfan pharmacokinetic lab cross verification results Personalizing busulfanbased conditioning: considerations from the American Society for Blood and Marrow Transplantation Practice Guidelines Committee Liquid chromatography- tandem mass spectrometry assay for androstenedione, dehydroepiandrosterone, and testosterone with pediatric and adult reference intervals Immunoassays for testosterone in women: better than a guess? |
| cord-002626-jzwwses4 | The'70% claim': what is the evidence base? |
| cord-002626-jzwwses4 | hdsa.org Targets for future clinical trials in Huntington's disease: what's in the pipeline? |
| cord-326922-bajpr5a2 | : where are we heading? |
| cord-326922-bajpr5a2 | An outbreak of postoperative gram- negative bacterial endophthalmitis associated with contaminated trypan blue ophthalmic solution Eye opening: are compounded drugs causing harm? |
| cord-326922-bajpr5a2 | Compounding pharmacies: a viable option, or merely a liability? |
| cord-326922-bajpr5a2 | Time for compounding certification? |
| cord-326922-bajpr5a2 | United States Food and Drug Administration United States Food and Drug Administration Compounded drugs: are customized prescription drugs a salvation, snake oil, or both? |
| cord-274061-ynqxgyw6 | Are we prepared to deal with potential threats from bioterrorism agents? |
| cord-274061-ynqxgyw6 | Does it make sense to screen all blood donations when risks of babesiosis and dengue are seasonal and geographical? |
| cord-274061-ynqxgyw6 | How much effort should be expended to prepare for an outbreak of chikungunya virus that might never happen? |
| cord-274061-ynqxgyw6 | More generally, as we become increasingly proactive in addressing infectious risks, are we misdirecting resources that could be better spent to improve blood safety in other ways? |
| cord-274061-ynqxgyw6 | What changes to the current paradigm of donor screening and testing can be considered when pathogen reduction becomes available for all blood components? |
| cord-274061-ynqxgyw6 | respiratory syndrome coronavirus in the absence of studies to establish the presence or absence of viremia in the course of the infections? |
| cord-018770-uy76mc2j | : is there room for improvement? |
| cord-018770-uy76mc2j | Had a transplant or other medical procedure that involved being exposed to live cells, tissues, or organs from an animal? |
| cord-018770-uy76mc2j | Has your sexual partner or a member of your household ever had a transplant or other medical procedure that involved being exposed to live cells, tissues, or organs from an animal? |
| cord-018770-uy76mc2j | Have any of your relatives had Creutzfeldt- Jakob disease? |
| cord-018770-uy76mc2j | The impact of the age of HLA- identical siblings on mobilization and collection of PBSCs for allogeneic hematopoietic cell transplantation Comparative outcome of nonmyeloablative and myeloablative allogeneic hematopoietic cell transplantation for patients older than 50 years of age Related hematopoietic cell donor care: is there a role for unrelated donor registries? |
| cord-018770-uy76mc2j | World Marrow Donor Association Clinical Working Group Committee Efficacy and safety of peripheral blood stem cell collection in elderly donors; does age interfere? |
| cord-018770-uy76mc2j | a consensus statement from the Worldwide Network for Blood and Marrow Transplantation( WBMT) Does matched unrelated donor transplantation have the same outcome as matched sibling transplantation in unselected patients? |
| cord-018770-uy76mc2j | when is it approvable? |
| cord-016293-pyb00pt5 | : Is There Ample Evidence? |
| cord-016293-pyb00pt5 | According to anecdotal evidence when visiting his namesake centre, Sanger asked:"What does this machine do then?""Dideoxy sequencing"came the reply, to which Fred retorted:"Have n't they come up with anything better yet?" |
| cord-016293-pyb00pt5 | According to anecdotal evidence when visiting his namesake centre, Sanger asked:"What does this machine do then?""Dideoxy sequencing"came the reply, to which Fred retorted:"Have n't they come up with anything better yet?" |
| cord-016293-pyb00pt5 | Issues of justice and resource allocation also have been raised: In a time of strain on our health care system, can we afford such expensive therapy? |
| cord-016293-pyb00pt5 | That finding led plant pathologist Roger Beachy, then at Washington University in Saint Louis, to wonder exactly how such"cross- protection"worked-did part of the virus prompt it? |
| cord-016293-pyb00pt5 | When Steve Fodor was asked in 2003"How do you really take the Human genome sequence and transform it into knowledge?" |
| cord-016293-pyb00pt5 | Who should receive gene therapy? |
| cord-280040-xphxlaat | Brief summary of the gastroenterology and urology devices panel meeting Gastrointestinal endoscopes: a need to shift from disinfection to sterilization? |
| cord-280040-xphxlaat | Delayed reprocessing of endoscopes Outbreaks of carbapenem- resistant Enteriobacteriaceae infections associated with duodenoscopes: what can we do to prevent infections? |
| cord-280040-xphxlaat | Evaluating hygienic cleaning in health care settings: what you do not know can harm your patients Monitoring the effectiveness of hospital cleaning practices by use of an adenosine triphosphate bioluminescence assay Interventional evaluation of environmental contamination by vancomycin- resistant enterococci: failure of personnel, product or procedure? |
| cord-280040-xphxlaat | Guidelines for environmental infection control in health- care facilities Disinfection and sterilization of prion- contaminated medical instruments, reply to Belay Efficacy of a washer- disinfector in eliminating healthcare- associated pathogens from surgical instruments FDA- cleared sterilants and high level disinfectants with general claims for processing reusable medical and dental devices Disinfection and sterilization in healthcare facilities Guidelines for infection control in dental health- care settings-2003 Disinfection: is it time to reconsider Spaulding? |
| cord-280040-xphxlaat | The role played by contaminated surfaces in the transmission of nosocomial pathogens Environmental contamination makes an important contribution to hospital infection Role of the environment in the transmission of Clostridium difficile in health care facilities Disinfectants used for environmental disinfection and new room decontamination technology Contamination of hands with methicillin- resistant Staphylococcus aureus after contact with environmental surfaces and after contact with the skin of colonized patients Methods for assessing the adequacy of practice and improving room disinfection Risk of acquiring antibiotic- resistant bacteria from prior room occupants Evaluation of hospital room assignment and acquisition of Clostridium difficile infection Does improving surface cleaning and disinfection reduce health care- associated infections? |
| cord-280040-xphxlaat | What should we do now? |
| cord-280040-xphxlaat | is perfusion of channels required? |
| cord-280040-xphxlaat | what can we do to prevent infections? |
| cord-287758-da11ypiy | ( COVID-19) Clinically Significant Drug Interactions with Cyclosporin Glycopeptide Antibiotics Potently Inhibit Cathepsin L in the Late Endosome/ Lysosome and Block the Entry of Ebola Virus, Middle East Respiratory Syndrome Coronavirus( MERS- CoV), and Severe Acute Respiratory Syndrome Coronavirus( SARS- CoV) Discovery and development of safe- in- man broadspectrum antiviral agents Teicoplanin: an alternative drug for the treatment of COVID-19? |
| cord-287758-da11ypiy | : cord-287758-da11ypiy authors: Mônica Vitalino de Almeida, Sinara; Cleberson Santos Soares, José; Lima dos Santos, Keriolaine; Emanuel Ferreira Alves, Josival; Galdino Ribeiro, Amélia; Trindade Tenório Jacob, Íris; Juliane da Silva Ferreira, Cindy; Celerino dos Santos, Jéssica; Ferreira de Oliveira, Jamerson; Bezerra de Carvalho Junior, Luiz; do Carmo Alves de Lima, Maria title: COVID-19 therapy: what weapons do we bring into battle? |
| cord-287758-da11ypiy | A Review of Its Use in the Management of HIV-1 Infection Discovering drugs to treat coronavirus disease 2019( COVID-19) Therapeutic Options and Critical Care Strategies in COVID-19 Patients; Where Do We Stand in This Battle? |
| cord-287758-da11ypiy | A new trick for an old drug? |
| cord-287758-da11ypiy | Antiviral treatment of COVID-19 Hydroxychloroquine and ivermectin: A synergistic combination for COVID-19 chemoprophylaxis and treatment? |
| cord-287758-da11ypiy | Clinical course and outcomes of critically ill patients with SARS- CoV-2 pneumonia in Wuhan, China: a single- centered, retrospective, observational study Are patients with hypertension and diabetes mellitus at increased risk for COVID-19 infection? |
| cord-287758-da11ypiy | Engineering an antiviral for COVID-19? |
| cord-287758-da11ypiy | How Far Are We? |
| cord-287758-da11ypiy | The Use of Cyclosporine A in Rheumatology: a 2016 Comprehensive Review Cyclosporine A: a valid candidate to treat COVID-19 patients with acute respiratory failure? |
| cord-287758-da11ypiy | The possible mechanisms of action of 4-aminoquinolines( chloroquine/ hydroxychloroquine) against Sars- Cov-2 infection( COVID-19): A role for iron homeostasis? |
| cord-287758-da11ypiy | The world is facing a huge challenge in the coronavirus disease( COVID-19) pandemic: How to fight an enemy without weapons in terms of therapy? |
| cord-354445-lnvc7mmf | 1994, 1995, and 1996 APIC Guidelines Committee High- level disinfection or"sterilization"of endoscopes? |
| cord-354445-lnvc7mmf | 5-year review Is bacteriologic surveillance in endoscope reprocessing stringent enough? |
| cord-354445-lnvc7mmf | Antimicrobial efficacy of endoscopic disinfection procedures: a controlled, multifactorial investigation High- level disinfection of gastrointestinal endoscopes: are current guidelines adequate? |
| cord-354445-lnvc7mmf | Guideline for disinfection and sterilization in healthcare facilities Guideline for disinfection and sterilization of prion contaminated medical instruments Disinfection: is it time to reconsider Spaulding? |
| cord-354445-lnvc7mmf | Low- temperature sterilization technologies: do we need to redefine sterilization? |
| cord-354445-lnvc7mmf | Mycobacteria and glutaraldehyde: is high- level disinfection of endoscopes possible? |
| cord-354445-lnvc7mmf | Sites need to have a response plan in place regarding notification if culture shows organisms of concern on an endoscope that has been used on multiple patients( i.e., notify the patient, the doctor or both?) |
| cord-354445-lnvc7mmf | Transmission of hepatitis B and C viruses in outpatient settings Viral hepatitis transmission in ambulatory health care settings Guideline for isolation precautions: preventing transmission of infectious agents in healthcare settings Evaluation of the risk of transmission of bacterial biofilms and clostridium difficile during gastrointestinal endoscopy ERCP scopes: what can we do to prevent infections? |
| cord-354445-lnvc7mmf | What is disinfection, sterilization? |
| cord-354445-lnvc7mmf | [ 510(k)] submissions for liquid chemical sterilants/ high level disinfectants Are all sterilization processes alike? |
| cord-354445-lnvc7mmf | principles in gastrointestinal endoscopy Infectious disease complications of GI endoscopy: part II, exogenous infections ERCP scopes: what can we do to prevent infections? |
| cord-354445-lnvc7mmf | what can we do to prevent infections? |
| cord-354445-lnvc7mmf | where do we go from here? |
| cord-014687-0am4l5ms | : How Big a Problem is It? |
| cord-014687-0am4l5ms | : Where Are We Now? |
| cord-014687-0am4l5ms | A conversant? |
| cord-014687-0am4l5ms | Been a leader in science and application? |
| cord-014687-0am4l5ms | Been part of the dialogue that has been increasingly influential across all of Radiology, a conversation steeped in a deep tradition of excellence in diagnosis and treatment, and the safety and welfare of our children? |
| cord-014687-0am4l5ms | Can Time- Resolved Contrast- Enhanced MRA( TWIST) Classify Soft Tissue Vascular Anomalies in the Head and Neck in Children Accurately? |
| cord-014687-0am4l5ms | Does a Tertiary Care Radiologist Make a Difference? |
| cord-014687-0am4l5ms | Has he been part of the Pediatric Radiology landscape these last ten years? |
| cord-014687-0am4l5ms | Horizons, innovation, and the gift of en- abling … What else is needed to define a true pioneer? |
| cord-014687-0am4l5ms | How can we maintain and expand these relationships? |
| cord-014687-0am4l5ms | How was this done? |
| cord-014687-0am4l5ms | Imaging Followup of Lymphoma in Pediatric Patients: Is Pelvic CT Necessary? |
| cord-014687-0am4l5ms | Imaging Pulmonary Tuberculosis in Infants: What are the Most Useful Diagnostic Radiological Findings? |
| cord-014687-0am4l5ms | Is Dedicated Chest CT needed in Addition to PET CT for Evaluation of Pediatric Oncology Patients? |
| cord-014687-0am4l5ms | M.D. Why George Bisset? |
| cord-014687-0am4l5ms | Part of the dialogue? |
| cord-014687-0am4l5ms | Part of the landscape? |
| cord-014687-0am4l5ms | Part of the science and application? |
| cord-014687-0am4l5ms | Sonographic Evaluation of Pediatric Skeletal Lesions: Is it worthwhile? |
| cord-014687-0am4l5ms | Utility of Contrast- Enhanced MR Imaging in Children with Osteonecrosis: Does Gadolinium Help? |
| cord-014687-0am4l5ms | With these successes in mind, who better to embody the concept of bridging horizons that is the theme for this entire meeting? |
| cord-010119-t1x9gknd | Among all potential causes investigated, only the gel card lot number was associated with the number of"?"generated( table 1). |
| cord-010119-t1x9gknd | Assuming 30 seconds of technologist time per"?", we estimate that 13.6 hours were needed to resolve and update these results. |
| cord-010119-t1x9gknd | Can Texting Decrease Wastage? |
| cord-010119-t1x9gknd | Interference: More Than Just Kell? |
| cord-010119-t1x9gknd | Is Its Use Inappropriate? |
| cord-010119-t1x9gknd | Of 19,647 columns run as part of antibody screens, 1,633( 8.3%) columns generated"? |
| cord-010119-t1x9gknd | Patient 1 was a 29 yo female, C2E2c1e1, whose RBCs reacted 11 by ECHO and 31 by NEO with anti- D4, and'?' |
| cord-010119-t1x9gknd | Platelet Rich Plasma and Quality Control: Is There a Role for the Blood Bank? |
| cord-010119-t1x9gknd | Shortly after implementation, technologists reported increased time spent performing manual resolution of indeterminate( designated as"?") results. |
| cord-010119-t1x9gknd | Study Design/ Method: We analyzed allogeneic interview responses to the screening question,"In the past 12 months have you had a tattoo?" |
| cord-010119-t1x9gknd | Study Design/ Methods: With assistance from Ortho Diagnostics, analyzer archives were queried to identify the number of gel card columns used for screens, the number of columns with"?"results, and the gel card lot numbers used for testing from 1/29/2017 to 3/31/2017. |
| cord-010119-t1x9gknd | Testing Worth the Headache? |
| cord-010119-t1x9gknd | Texas Children's Hospital, 2 Baylor College of Medicine AP127 Vision Titers--Easier or Problematic? |
| cord-010119-t1x9gknd | The Future of Plasma Therapy? |
| cord-010119-t1x9gknd | The incidence of"?"and visually negative analyzer positive results is dependent on the specific lot of MTS- Gel TM cards used. |
| cord-010119-t1x9gknd | The objective of this study was to investigate the cause of"?"and apparent false positive results on VisionV R three- cell antibody screens. |
| cord-010119-t1x9gknd | Variations in Biochemical Markers of Bone Metabolism during Plateletpheresis: Impact of Socio- Demographic and Lifestyle Factors? |
| cord-010119-t1x9gknd | Were Patients Transfused after Testing? |
| cord-010119-t1x9gknd | What Is the Best Practice for Testing Residual White Blood Cells in Blood Components for Monthly Routine Quality Control? |
| cord-010119-t1x9gknd | Where We Go? |
| cord-017208-7oew461e | ( For replication- selective vectors, what is the molecular basis of the selectivity and the conditions under which the vector would replicate?) |
| cord-017208-7oew461e | Are alternative methods of selection available? |
| cord-017208-7oew461e | Are data available evaluating the genetic stability of the recombinant vector? |
| cord-017208-7oew461e | Are data available evaluating the potential for genetic recombination with other organisms in the patient or in the environment? |
| cord-017208-7oew461e | Are the biological features of the vector, and its transgene when applicable, clearly similar in the animal species used for safety studies and in the human, at least as far as this can be ascertained? |
| cord-017208-7oew461e | Are there any safety issues connected with the production, purification, and/or handling of the product? |
| cord-017208-7oew461e | Are there issues of formulation that must be resolved? |
| cord-017208-7oew461e | Are there reproducible assays for the product? |
| cord-017208-7oew461e | Can successive batches of the material be made reproducibly in the quantity to support clinical development, and how is this known? |
| cord-017208-7oew461e | Do you have any information regarding the estimated costs of this production project? |
| cord-017208-7oew461e | Does the construct contain an antibiotic resistance gene or other selectable marker? |
| cord-017208-7oew461e | Does the vector have an altered cell tropism? |
| cord-017208-7oew461e | For example, are the safety issues primarily related to the vector, the transgene product, the method of administration, the formulation/ excipient, or some combination of the above? |
| cord-017208-7oew461e | For example, would there be an advantage to performing the studies in rodents when larger numbers of animals might be more practical, or is there a necessity for a large animal model, such as a canine or nonhuman primate? |
| cord-017208-7oew461e | Has a source of funding been identified for performing the clinical trial with this product? |
| cord-017208-7oew461e | Has this construct been sequenced? |
| cord-017208-7oew461e | Has this material been produced in a related or other production system? |
| cord-017208-7oew461e | Has this material ever been produced for laboratory or clinical studies using this production system? |
| cord-017208-7oew461e | Have there been any meetings scheduled with regulatory agencies, such as a pre- IND meeting with the FDA or a presentation to the NIH RAC? |
| cord-017208-7oew461e | Have you identified any possible sources of production with any commercial firms? |
| cord-017208-7oew461e | How does one know that a lot of product is qualified for use? |
| cord-017208-7oew461e | How does this scale to anticipated quantities for clinical trial? |
| cord-017208-7oew461e | How might existing published or unpublished nonclinical or clinical data address the questions mentioned above? |
| cord-017208-7oew461e | How much material is available as a reference standard? |
| cord-017208-7oew461e | How will the presence and distribution of the gene therapy agent be followed in the patient? |
| cord-017208-7oew461e | If nonhuman primate studies are proposed, is it clear that another large animal or rodent model would not provide the same information? |
| cord-017208-7oew461e | If not, is there a qualified cell line available for propagation of this vector? |
| cord-017208-7oew461e | If you have had a pre- IND or RAC meeting, were any issues concerning manufacturing, safety, or stability raised that will have an impact on producing your product? |
| cord-017208-7oew461e | In broad strokes, these involve approaches to answering the following questions: Is the identity of the agent clearly defined? |
| cord-017208-7oew461e | In what form( lyophilized, formulated product, and so on) and fill size is the desired final product? |
| cord-017208-7oew461e | Is material available as bulk biological substance for preliminary pharmacology and toxicology studies? |
| cord-017208-7oew461e | Is the organism currently grown in a qualified cGMP cell line? |
| cord-017208-7oew461e | Is the vector replication competent or replication defective? |
| cord-017208-7oew461e | Is there a cGMP- qualified virus seed bank? |
| cord-017208-7oew461e | Is there a danger of producing directly( as the therapeutic agent itself) or indirectly( through recombination and/or replication) an infectious agent that acts horizontally in the population or vertically across generations? |
| cord-017208-7oew461e | Is toxicity after repeated doses of agent likely to be attenuated or magnified by immunological response to the agent? |
| cord-017208-7oew461e | Some of the questions that should be answered by preclinical pharmacology/ toxicology studies are the following( 43): What is the relationship of the dose to the biologic activity? |
| cord-017208-7oew461e | Was the cell line genetically modified to support this vector? |
| cord-017208-7oew461e | What are the consequences of long- term presence of the therapeutic agent in the recipient? |
| cord-017208-7oew461e | What are to be the release criteria for the product? |
| cord-017208-7oew461e | What dose is likely to be required for therapeutic effect? |
| cord-017208-7oew461e | What is known about the product stability with respect to physical integrity and activity? |
| cord-017208-7oew461e | What is the average yield of the production system before and after purification? |
| cord-017208-7oew461e | What is the desired final product formulation? |
| cord-017208-7oew461e | What is the effect of altered tropism on anticipated host toxicity? 6. |
| cord-017208-7oew461e | What is the largest amount of material that you have produced in your laboratory in a single production batch? |
| cord-017208-7oew461e | What is the relationship of the dose to the toxicity? |
| cord-017208-7oew461e | What is the status of the product(s) regarding intellectual property issues? |
| cord-017208-7oew461e | What level of gene expression or replication is necessary to attain a therapeutic effect? |
| cord-017208-7oew461e | What risks can be identified for the clinical trial? |
| cord-017208-7oew461e | When toxicity occurs because of the agent, what is the evidence the toxicity will be reversible? |
| cord-017208-7oew461e | Who will sponsor the IND for the proposed study? |
| cord-017208-7oew461e | Why was the proposed selection chosen? |
| cord-017208-7oew461e | Would there be any utility in a genetically deficient model, and would this deficient model be more relevant to the proposed study either because of the potential for adverse immunologic consequences or because of the biological effects in the deficient condition? |
| cord-017208-7oew461e | and/or rates of reversion to either wild- type or alternate viral genomes? |
| cord-017208-7oew461e | and/or toxicity? |