DESIGN OF EARLY CLINICAL TRIALS FOR NEW CONTRACEPTIVE METHODS

1974 ◽  
Vol 77 (1_Suppla) ◽  
pp. S266-S278
Author(s):  
Daniel R. Mishell ◽  
Harold A. Nash
Keyword(s):  
Clinical Trials ◽  
Large Scale ◽  
Clinical Investigation ◽  
Toxicity Testing ◽  
Field Trials ◽  
New Drugs ◽  
Animal Testing ◽  
Good Continuation ◽  
Large Scale Field ◽  
Pharmaceutical Agents

ABSTRACT A plan is outlined to shorten the current suggested duration of animal testing prior to clinical investigation with certain types of pharmaceutical agents. For many new drugs, especially steroids, after a pharmacologic profile is established, long term toxicity testing can usually be shortened prior to initiation of 6 months clinical trials involving about 1000 women. Clinical trials of this magnitude usually correlate very well with ultimate performance of contraceptive drugs, provided proper selection of subjects is performed with resultant good continuation rates. It is thus possible with certain new antifertility candidates to safely shorten the duration of both toxicological and clinical studies before initiating large scale field trials.

Effects of irrigation regimes on powdery scab disease and yield of potatoes

1986 ◽  
Vol 26 (6) ◽  
pp. 745 ◽  
Author(s):  
PA Taylor ◽  
SP Flett ◽  
RFde Boer ◽  
D Marshall
Keyword(s):  
Large Scale ◽  
Field Experiments ◽  
Field Trials ◽  
Powdery Scab ◽  
Infested Soil ◽  
Spongospora Subterranea ◽  
Potato Tubers ◽  
Potato Plants ◽  
Tuber Set ◽  
Large Scale Field

The period of susceptibility of potato tubers to powdery scab (Spongospora subterranea) was studied by inoculating potato plants with spores, or by watering plants in infested soil, at different stages of plant development in greenhouse conditions. Maximum susceptibility began about 1 week before the stage when 50% of stolons had swollen to at least 5-mm diameter (tuber set), and ended 3-4 weeks later. With holding irrigation water during this period reduced the severity of powdery scab by 65-75% in field experiments in 1981-82 and 1982-83, but had no apparent effect on disease severity in 3 out of 6 large-scale field trials during 1984-85.

Large-Scale Field Trials on Dense Vapour Dispersion

1985 ◽  
pp. 179-189 ◽  
Author(s):  
J. McQuaid ◽  
B. Roebuck ◽  
D. G. Wilde
Keyword(s):  
Large Scale ◽  
Field Trials ◽  
Scale Field ◽  
Large Scale Field

scholarly journals Off-Site Lime Stabilisation as an Option to Treat Pit Latrine Faecal Sludge for Emergency and Existing On-Site Sanitation Systems

2016 ◽  
Vol 2016 ◽  
pp. 1-8 ◽  
Author(s):  
Wilson Greya ◽  
Bernard Thole ◽  
Catherine Anderson ◽  
Flavius Kamwani ◽  
Jan Spit ◽  
...  
Keyword(s):  
Large Scale ◽  
Buffer Capacity ◽  
Hydrated Lime ◽  
Field Trials ◽  
Small Scale ◽  
E Coli ◽  
Scale Field ◽  
Large Scale Field ◽  
Sanitation Systems ◽  
Faecal Sludge

Off-site lime stabilisation for treating faecal sludge was assessed by undertaking small-scale (35 L) and large-scale (600 L) field trials in Blantyre, Malawi. Hydrated lime was dosed to maintain pH 10, pH 10.5, pH 11, pH 11.5, and pH 12 depending on the buffer capacity of the faecal sludge in the four replica small-scale field trials. Significant reduction of E. coli to below the detection limit of 104 CFU/100 mL within 1 hour of treatment was reported for pH > 11. Based on the small-scale findings, large-scale field trials were conducted and greater than 3 log removal of E. coli was observed under pH 12 conditions. Therefore, based on the study, off-site lime stabilisation by dosing lime in the range of 10–35% w/w (dry solid basis), depending on the buffer capacity and solids content of the sludge to maintain pH > 11, can be used to sanitise faecal sludge during emergencies, as well as for existing on-site sanitation systems.

Pattern recognition of cardoon oil from different large-scale field trials

2018 ◽  
Vol 118 ◽  
pp. 236-245 ◽  
Author(s):  
Suzana Ferreira-Dias ◽  
Jorge Gominho ◽  
Isabel Baptista ◽  
Helena Pereira
Keyword(s):  
Pattern Recognition ◽  
Large Scale ◽  
Field Trials ◽  
Scale Field ◽  
Large Scale Field

The influence of nutritional level in early pregnancy of the ewe

1969 ◽  
Vol 73 (3) ◽  
pp. 387-394 ◽  
Author(s):  
I. E. Coop ◽  
V. R. Clark
Keyword(s):  
Early Pregnancy ◽  
Large Scale ◽  
Live Weight ◽  
Late Pregnancy ◽  
Field Trials ◽  
Main Effect ◽  
Large Scale Field ◽  
Fleece Weight ◽  
Sound Policy ◽  
Time Restriction

SummaryA series of three large-scale field trials, involving 3500 ewes over a 3-year-period, was conducted to study the effect of restricted nutrition of breeding ewes in early pregnancy. Control or non-restricted ewes were fed at approximately maintenance level and restricted ewes at approximately half-maintenance. The majority of ewes fell into two categories—those 2–3 weeks pregnant at the time restriction was commenced and those 5–7 weeks pregnant. Restriction was applied for from 5 to 8 weeks, live-weight differences of approximately 10 1b were achieved.Differences in performance in individual trials were invariably very small, and nonsignificant. The main effect of restricted nutrition over all trials was to decrease twinning by 0·5% and decrease the number of barren ewes by 0·8%. These differences are considered to be negligible. Only one statistically significant effect was observed within one of the trials—this was a depression in twinning in ewes 18–24 days pregnant at the time of applying the treatment, but this effect could not be confirmed in the other two trials. However, the fleece grown was affected by treatment—the fleece weight being depressed by approximately ½ lb, and grade reduced slightly.It is concluded that restricted nutrition at the level and time applied has no effect on reproductive performances of ewes and therefore the practice of restriction in early pregnancy to conserve feed for late pregnancy is a sound policy.

Reproductive toxicity testing of pharmaceutical compounds to support the inclusion of women in clinical trials

1997 ◽  
Vol 16 (5) ◽  
pp. 239-246 ◽  
Author(s):  
Chris Parkinson ◽  
Kate E Thomas ◽  
Cyndy E Lumley
Keyword(s):  
Clinical Trials ◽  
Drug Development ◽  
Animal Studies ◽  
Clinical Investigation ◽  
Reproductive Toxicity ◽  
Toxicity Testing ◽  
Toxicity Tests ◽  
Toxicity Studies ◽  
Important Concern ◽  
The Usa

1 The potential for toxicity to reproduction and the developing fetus is an important concern requiring attention during the development of new medicines. However, there are differences in the opinions of the regulatory authorities in Europe, Japan and the USA regarding the nature and amount of data from reproductive toxicity tests that should be available at the various stages of clinical development. 2 Forty-one companies or their subsidiaries from Eur ope, Japan and the USA provided data for a ques tionnaire-based study, carried out in 1994, to ascertain the practices of pharmaceutical companies and their views on an ideal approach to the timing of reproduc tion and development toxicity studies in relation to clinical investigation. 3 Differences were identified in the stage of drug development at which animal studies were completed, the sequence of completion of specific studies, and the extent of reproduction testing completed to support the inclusion of women in clinical trials. 4 A harmonised, but flexible, guideline, encompassing the timing of reproductive toxicity studies in relation to clinical trials, would permit better integration between clinical and non-clinical studies in an international drug development programme.

scholarly journals Large-scale Field Trials of Imidacloprid for Control of the Spined Citrus Bug

HortScience ◽  
2003 ◽  
Vol 38 (4) ◽  
pp. 555-559
Author(s):  
J. Mo ◽  
K. Philpot
Keyword(s):  
Natural Enemies ◽  
Large Scale ◽  
New South ◽  
Field Trials ◽  
Negative Effects ◽  
South Wales ◽  
Tree Canopies ◽  
Scale Field ◽  
Large Scale Field ◽  
Orange Trees

Four large-scale field trials were carried out in 2001 and 2002 in lemon orchards in south-western New South Wales to assess the suitability of imidacloprid as a replacement for endosulfan in controlling the spined citrus bug (SCB), Biprorulus bibax Breddin (Hemiptera: Pentatomidae). The results showed that imidacloprid was at least as effective as endosulfan in controlling SCB, even when it was applied at a rate corresponding to half of its discriminate dose (100% kill). The application of imidacloprid did not reduce numbers of wasps and spiders foraging in tree canopies. However, imidacloprid was more toxic than endosulfan to parasitoids of the red scale and to lacewings. These negative effects can be minimised by timing the sprays in winter, when SCB adults congregate in neighbouring orange trees and the numbers of natural enemies of citrus pests are generally low.

Chinese Pharmacopoeia Revisited: A Review of Anti-Depression Herbal Sources

2021 ◽  
Vol 16 (12) ◽  
pp. 1934578X2110593
Author(s):  
Dongyi Hu ◽  
Jiayu Gao ◽  
Xiao Yang ◽  
Ying Liang
Keyword(s):  
Clinical Trials ◽  
Large Scale ◽  
Life Quality ◽  
Herbal Medicines ◽  
Antidepressant Drugs ◽  
New Drugs ◽  
Chinese Herbs ◽  
Evidence Based ◽  
Chinese Pharmacopoeia ◽  
Bupleuri Radix

Depression, which can be accompanied by many fatal diseases and a low life quality, has become the leading cause of ill health and disability worldwide. However, Chinese Pharmacopoeia, the most authoritative and evidence-based encyclopedia of Traditional Chinese Medicine (TCM), could contain leads and insights into the development of new antidepressant drugs. In this work, nine herbal medicines with ‘dispel melancholy functions’ specifically documented in Chinese Pharmacopoeia have been comprehensively reviewed with respect to clinical trials, and phytochemical and pharmacological aspects. The nine drugs are Rosae Chinensis Flos, Croci Stigma, Albiziae Cortex and Flos, Roase Rugosae Flos, Curcumae Radix, Hyperici Perforati Herba, Cyperi Rhizoma and Bupleuri Radix. The mechanisms of action of their functional antidepressant compounds, including gallic acid, hypericin, kaempferol, crocetin, crocin, quercetin, luteolin, isorhamnetin, curcumin, hyperforin, adhyperforin, catechin, rutin, puerarin, and saikosaponins A and D, have been collected and discussed. These traditional Chinese herbs and their active compounds provide a promising resource to develop effective new antidepressant drugs in future. Moreover, mechanistic investigations, safety verification and large-scale clinical trials are still expected to finally transform such TCM-based antidepressant resources to new drugs for patients suffering from depression.

Sign in / Sign up

Export Citation Format

Share Document