Biotechneuling bittet um Aufklärung! - 500 Beiträge pro Seite

[boertropi]

Biotech ist im Augenblick absolut in.
Wer hat Ahnung davon und kann mir folgende Fragen beantworten:
-wieviele klinische Phasen gibt es?
-wie lange dauern die normalerweise?
-wenn ein neuer Wirkstoff alle klinischen Phasen übersteht, ist er damit schon marktfähig oder folgen den klinischen Phasen weitere Forschungen?
Vielen Dank im voraus!!!

[kleinsr]

Also, ich kann dir zumindest sagen dass es drei klinische Phasen gibt. Danach ist das Medikament marktreif, braucht aber noch die Zulassung. Wie lange das alles dauert, kann ich dir nicht genau sagen, einige Jahre musst du aber schon rechnen....
Gruß, Ralf.

[cherub]

The Clinical Trial Process
The drug approval process starts in the laboratory. After discovering a
promising compound, studies using the compound in cell cultures, isolated
tissues, and laboratory animals are conducted. This gives researchers a
pretty good idea of what to expect in human trials. On average, only one
compound in a thousand will actually make it to human testing. Assuming
the data is promising, the company makes the decision whether to begin the
long and costly process of getting the compound to market. Since most drug
companies have multiple candidates, the company must take into account the
size of the potential patient population, whether the market for that
particular drug is already well-served, and the company`s financial
situation, all of which will factor in to the decision to begin clinical
trials. Because most companies file for and receive patents for the
commercial use of the compound that they are developing during
pre-clinical trials, the patent clock usually starts ticking at this
point. Patents generally last between 17 years for those dated before June
7, 1995, and 20 years for patents granted after that date. The
pre-clinical trials for most drugs average about five years.Also, the
patent protection for the drug, generally lasting 17 years, begins to tick
once the compound begins pre-clinical trials. The pre-clinical trials for
most drugs average about five years.

Assuming the company decides to pursue human studies, it must first submit
an Investigational New Drug application to the FDA for approval. The IND
becomes effective 30 days after receipt by the FDA (assuming the FDA does
not require further information), and must be filed annually thereafter
until the completion of clinical testing. The IND must provide
pre-clinical data of sufficient quality to justify the testing of the drug
in humans. About 85% of all IND applications move on to begin clinical
trials. Assuming the company receives FDA go-ahead, the company will move
the drug on to Phase 1 testing in human subjects. At this point, the
compound has a one in five chance of eventually reaching the market, and
will normally take another five to nine years to reach that destination.

Phase 1
Phase 1 trials concentrate on developing the drug`s safety profile. The
human subjects in the study are normally healthy volunteers, though
sometimes patients who have terminal illnesses and have no other
therapeutic alternative will take part in Phase 1 studies as well. The
sample is normally not more than 100 patients in Phase 1. The basic goal
of Phase 1 is to determine how the drug is absorbed, distributed in the
body, metabolized, and excreted. The duration of the drug`s effects are
also measured. Phase 1 testing ranges from one to three years, on average.

Assuming the data from Phase 1 are positive and the safety of the compound
is established, the drug moves on to Phase 2 testing. If the company moves
on to begin Phase 2 trials, the drug`s chance of eventually making it to
market improves to just under 30%.

Phase 2
Phase 2 trials consist of small, well-controlled experiments to continue
to evaluate the drug`s safety and assess side effects. The drugs are given
to volunteers (usually between 100 and 300 patients) who actually suffer
from the disease or condition being targeted by the drug. This phase is
where the optimal dosage of the drug is established. Also, statistical end
points are established for the drug that represent the targeted favorable
outcome of the study. The current standard of care for the medical
condition can be used as a benchmark in setting the end point. Phase 2
trials last an average of two years.

A drug that moves on to begin Phase 3 testing has about a 60% chance of
actually being approved by the FDA.

Phase 3
Phase 3 testing is intended to verify the effectiveness of the drug
against the condition that it targets, based on the statistical end points
established in Phase 2. The study also continues to build the safety
profile of the drug and record possible side effects and adverse reactions
resulting from long-term use. Phase 3 studies are tightly controlled,
double-blind studies with a sample size of at least 1000 patients. If the
drug proves to be effective in this stage, the trial is deemed successful
(pivotal). Normally two pivotal trials are required to ensure the validity
of the studies, although if the results are extremely strong, one may
suffice. Phase 3 testing averages between three and four years.

Assuming the drug reaches the desirable end point in Phase 3 trials, the
company will then file a New Drug Application, which can contain 100,000
pages of data supporting the efficacy and safety of the drug. At this
point, the drug has better than a 70% chance of being approved by the FDA.

Approval of the NDA can take anywhere from two months to an extreme of
several years (in the case that the FDA requests additional information),
with an average wait of between 18 and 24 months. Upon approval, the
company may begin to market and distribute the drug.

Phase 4
Once the drug is on the market, the company must continue to perform
observational studies in an ongoing evaluation of the drug`s safety during
routine use. The company also attempts to monitor any usage of the drug
for conditions other than the approved medical indication. If the drug is
being successfully used for off-label indications, the company will often
initiate further clinical trials for those indications in order to widen
the potential market for the drug. The company cannot advertise or endorse
off-market use of the drug, however.



Zusammengefasst: Es dauert echt lang.

Quelle: Fool.com

[boertropi]

danke kleinsr, danke cherub,
meine Englischkenntnisse sind mehr als miserabel, aber mit einem Wörterbuch werde ich es schon hinkriegen. Hoffentlich bin ich bis zum Formel 1-Start, spätestens bis zum EM-Finale fertig. Wenn ich die Lust verlieren sollte, beherzige ich einfach cherubs Zusammenfassung: es dauert halt lange!!!

[money-maker]

Hi,

die telebörse (zeitschrift) hatte in den letzten Monaten eine Serie zur Biotechnologie abgedruckt, wenn du dir Zugang zur Zeitschrift verschaffen kannst, dann findest du dort in den Heften dieses Jahres einige wirklich gute Informationen auch zu diener Frage und einige gute Tipps.

m-m

[francoir]

Für Übersetzungen in vielen Sprachen gibt es ein sehr hilfreiches Tool auf den Seiten von www.altavista.com. Unter dem Banner Translate anklicken. Text eingeben, rein kopieren, oder ganze Internetseiten übersetzen lassen. Klappt super und sind wenn auch nicht perfekte, aber verständliche Übersetzungen.
Klasse Seite für US-Biotech-Stocks ist die von biospace.com. Jedem, der sich mit dieser Materie befasst, ist diese Seite zu empfehlen.

[boertropi]

guter vorschlag, wer kennt die web-adresse der zeitschrift: die telebörse???