Some very interesting info for folks who have had bioequivalence issues with generics
@rahaeli.bsky.social We've talked about generics not working. Here are some actions being taken by the FDA. I don't see what drugs were impacted though.
www.fda.gov/drugs/drug-s...
www.fda.gov/drugs/drug-s...
Certain studies conducted by Raptim Research Pvt. Ltd are unacceptable
FDA has identified significant data integrity and study conduct concerns with bioequivalence and bioavailability studies conducted by Raptim Research Pvt. Ltd.
www.fda.gov
May 3, 2025 at 11:15 PM
Some very interesting info for folks who have had bioequivalence issues with generics
This lab conducts research on pharmaceutical manufacturing, drug formulation, and characterization. It also provides scientific training to FDA staff on crucial aspects of drug quality and bioavailability/bioequivalence
March 4, 2025 at 11:44 PM
This lab conducts research on pharmaceutical manufacturing, drug formulation, and characterization. It also provides scientific training to FDA staff on crucial aspects of drug quality and bioavailability/bioequivalence
Reports to MedWatch were how the FDA discovered some bioequivalence studies were just straight up faking data without actually conducting the studies, for instance: www.fda.gov/drugs/drug-s...
Certain studies conducted by Raptim Research Pvt. Ltd are unacceptable
FDA has identified significant data integrity and study conduct concerns with bioequivalence and bioavailability studies conducted by Raptim Research Pvt. Ltd.
www.fda.gov
October 14, 2025 at 11:09 PM
Reports to MedWatch were how the FDA discovered some bioequivalence studies were just straight up faking data without actually conducting the studies, for instance: www.fda.gov/drugs/drug-s...
PKPD BABE
pharmacokinetics (PK)
pharmacodynamics (PD)
bioavailability (BA)
bioequivalence (BE)
🧪 🩺 #PharmSky
pharmacokinetics (PK)
pharmacodynamics (PD)
bioavailability (BA)
bioequivalence (BE)
🧪 🩺 #PharmSky
What would your most nerdy knuckle tats say?
Mine might be: MORE SALT.
Mine might be: MORE SALT.
dad at this playground has knuckle tats that say BOOK WORM, which is a perfect combo of nerdy and badass
June 10, 2024 at 12:22 AM
PKPD BABE
pharmacokinetics (PK)
pharmacodynamics (PD)
bioavailability (BA)
bioequivalence (BE)
🧪 🩺 #PharmSky
pharmacokinetics (PK)
pharmacodynamics (PD)
bioavailability (BA)
bioequivalence (BE)
🧪 🩺 #PharmSky
Bioavailability impacts a drug's effectiveness and safety profile and how much of the active ingredient reaches the bloodstream and is available at the site of action. Bioequivalence studies show that a cheap generic drug is interchangeable with a brand-name drug. Kinda useful.
March 4, 2025 at 11:44 PM
Bioavailability impacts a drug's effectiveness and safety profile and how much of the active ingredient reaches the bloodstream and is available at the site of action. Bioequivalence studies show that a cheap generic drug is interchangeable with a brand-name drug. Kinda useful.
Oh god just don't get me started on alleged bioequivalence, I'll be ranting all day (I'm one of those people!) Reminder: you can report these! It will not be immediate but if there's a genuine bioequivalence problem it WILL eventually be figured out! bsky.app/profile/raha...
Periodic reminder: if you get a generic that is less effective for you, of any medicine, filing a Form 3500 with the FDA's MedWatch if you're able contributes to getting non-bioequivalent generics pulled from the market: www.fda.gov/safety/medic...
May 6, 2026 at 5:54 PM
Oh god just don't get me started on alleged bioequivalence, I'll be ranting all day (I'm one of those people!) Reminder: you can report these! It will not be immediate but if there's a genuine bioequivalence problem it WILL eventually be figured out! bsky.app/profile/raha...
If not totally faked! Reports to MedWatch of generics not being bioequivalent is part of how the FDA discovered one common outsourcing company for bioequivalence studies was just flat out making shit up: www.fda.gov/drugs/drug-s...
Certain studies conducted by Raptim Research Pvt. Ltd are unacceptable
FDA has identified significant data integrity and study conduct concerns with bioequivalence and bioavailability studies conducted by Raptim Research Pvt. Ltd.
www.fda.gov
June 11, 2025 at 2:55 PM
If not totally faked! Reports to MedWatch of generics not being bioequivalent is part of how the FDA discovered one common outsourcing company for bioequivalence studies was just flat out making shit up: www.fda.gov/drugs/drug-s...
The FDA is the agency that certifies generic manufacturers' versions of a drug are "bioequivalent" aka the same drug that works in the same way at the same rate. They require bioequivalence studies for generic approval, but the studies are often half-assed.
June 11, 2025 at 2:55 PM
The FDA is the agency that certifies generic manufacturers' versions of a drug are "bioequivalent" aka the same drug that works in the same way at the same rate. They require bioequivalence studies for generic approval, but the studies are often half-assed.
oh god don't get me started on "bioequivalence" and how we determine it, we'll be here all night, lol
May 14, 2025 at 11:56 PM
oh god don't get me started on "bioequivalence" and how we determine it, we'll be here all night, lol
Why do I go by the handle I do? Because I’m a gigantic drug nerd 🤓💊
PKPD
PK - pharmacokinetics
PD - pharmacodynamics
BABE, not “babe”, but rather
BA - bioavailability
BE - bioequivalence
What about y’all? 🧪 🩺 #Neuroskyence
PKPD
PK - pharmacokinetics
PD - pharmacodynamics
BABE, not “babe”, but rather
BA - bioavailability
BE - bioequivalence
What about y’all? 🧪 🩺 #Neuroskyence
August 12, 2023 at 7:10 PM
Why do I go by the handle I do? Because I’m a gigantic drug nerd 🤓💊
PKPD
PK - pharmacokinetics
PD - pharmacodynamics
BABE, not “babe”, but rather
BA - bioavailability
BE - bioequivalence
What about y’all? 🧪 🩺 #Neuroskyence
PKPD
PK - pharmacokinetics
PD - pharmacodynamics
BABE, not “babe”, but rather
BA - bioavailability
BE - bioequivalence
What about y’all? 🧪 🩺 #Neuroskyence
Oh god the variability of the bioequivalence of generic concerta is so bad
May 2, 2024 at 9:32 PM
Oh god the variability of the bioequivalence of generic concerta is so bad
Oh god don't fucking get me started on bioequivalence in generics and how woefully inadequate our testing is EVEN WHEN THE DRUG COMPANIES DON'T JUST MAKE SHIT UP bsky.app/profile/raha...
Some very interesting info for folks who have had bioequivalence issues with generics
@rahaeli.bsky.social We've talked about generics not working. Here are some actions being taken by the FDA. I don't see what drugs were impacted though.
www.fda.gov/drugs/drug-s...
www.fda.gov/drugs/drug-s...
June 11, 2025 at 4:04 AM
Oh god don't fucking get me started on bioequivalence in generics and how woefully inadequate our testing is EVEN WHEN THE DRUG COMPANIES DON'T JUST MAKE SHIT UP bsky.app/profile/raha...
The target population for the research question is the population of people who would satisfy the eligibility criteria. “
Wrong x 2
1) The eligibility criteria define who doesn’t come into the trial not who does.
2) We generalise from quite different trials to populations eg bioequivalence trials.
Wrong x 2
1) The eligibility criteria define who doesn’t come into the trial not who does.
2) We generalise from quite different trials to populations eg bioequivalence trials.
November 1, 2025 at 7:03 PM
The target population for the research question is the population of people who would satisfy the eligibility criteria. “
Wrong x 2
1) The eligibility criteria define who doesn’t come into the trial not who does.
2) We generalise from quite different trials to populations eg bioequivalence trials.
Wrong x 2
1) The eligibility criteria define who doesn’t come into the trial not who does.
2) We generalise from quite different trials to populations eg bioequivalence trials.
In China, the approval of generic drugs falls under the purview of the National Medical Products Administration (NMPA). Generics have to pass a bioequivalence test/clinical trial, which shows they become available in the body to the same extent as brand name drugs.
January 23, 2025 at 7:57 AM
In China, the approval of generic drugs falls under the purview of the National Medical Products Administration (NMPA). Generics have to pass a bioequivalence test/clinical trial, which shows they become available in the body to the same extent as brand name drugs.
@rahaeli.bsky.social We've talked about generics not working. Here are some actions being taken by the FDA. I don't see what drugs were impacted though.
www.fda.gov/drugs/drug-s...
www.fda.gov/drugs/drug-s...
Certain studies conducted by Raptim Research Pvt. Ltd are unacceptable
FDA has identified significant data integrity and study conduct concerns with bioequivalence and bioavailability studies conducted by Raptim Research Pvt. Ltd.
www.fda.gov
May 3, 2025 at 7:28 PM
@rahaeli.bsky.social We've talked about generics not working. Here are some actions being taken by the FDA. I don't see what drugs were impacted though.
www.fda.gov/drugs/drug-s...
www.fda.gov/drugs/drug-s...
My maintenance painkiller goes generic in the IR next year and the ER in 2028 and I am immensely fucking dreading the insurance fight to stay on the ER after the IR goes generic and the bioequivalence problems with the generics once the ER goes generic
June 15, 2024 at 6:06 PM
My maintenance painkiller goes generic in the IR next year and the ER in 2028 and I am immensely fucking dreading the insurance fight to stay on the ER after the IR goes generic and the bioequivalence problems with the generics once the ER goes generic
With this FDA it's a crap shoot, but I always file MedWatch complaints (www.fda.gov/safety/medwa...) when I have generic variation problems (MedWatch is how they discovered a bunch of manufacturers were just faking bioequivalence studies!)
MedWatch: FDA Safety Information & Adverse Event Reporting Program
Reporting on prescription/OTC medicines, non-vaccine biologicals, medical devices, special nutritional products, cosmetics and non-prescription human drug.
www.fda.gov
February 12, 2026 at 2:57 AM
With this FDA it's a crap shoot, but I always file MedWatch complaints (www.fda.gov/safety/medwa...) when I have generic variation problems (MedWatch is how they discovered a bunch of manufacturers were just faking bioequivalence studies!)
She's right, but why is anyone going on air about this to recommend Tylenol the brand-name product?
Generic acetaminophen has been out for >40 years. It's as safe as Tylenol. By law, the FDA requires rigorous testing: Generic drugs must demonstrate bioequivalence to the brand product.
Generic acetaminophen has been out for >40 years. It's as safe as Tylenol. By law, the FDA requires rigorous testing: Generic drugs must demonstrate bioequivalence to the brand product.
Doctor: Decreasing the use of Tylenol in patients who need to be treated for their fevers or for other symptoms is not risk-free. So what Trump said isn't how we practice medicine in the US
September 22, 2025 at 5:34 PM
She's right, but why is anyone going on air about this to recommend Tylenol the brand-name product?
Generic acetaminophen has been out for >40 years. It's as safe as Tylenol. By law, the FDA requires rigorous testing: Generic drugs must demonstrate bioequivalence to the brand product.
Generic acetaminophen has been out for >40 years. It's as safe as Tylenol. By law, the FDA requires rigorous testing: Generic drugs must demonstrate bioequivalence to the brand product.
yeah, my PBM allowed the brand name substitutes while the generics were still in shortage, which I relied on to ditch the bioequivalence issues, but the shortage is "officially" resolved now (it's not) and that trick doesn't work anymore, siiiiigh
June 21, 2026 at 2:54 PM
yeah, my PBM allowed the brand name substitutes while the generics were still in shortage, which I relied on to ditch the bioequivalence issues, but the shortage is "officially" resolved now (it's not) and that trick doesn't work anymore, siiiiigh
Celon Pharma's generic semaglutide drug matches Ozempic in early study, shares jump reut.rs/4g4dx72
Celon Pharma's generic semaglutide drug matches Ozempic in early study, shares jump
Celon Pharma's experimental semaglutide product Reduzek, a generic alternative to Novo Nordisk's Wegovy and Ozempic, matched the blockbuster weight-loss drugs in an early-stage bioequivalence study, the Polish drugmaker said on Thursday.
reut.rs
August 20, 2026 at 12:15 PM
Celon Pharma's generic semaglutide drug matches Ozempic in early study, shares jump reut.rs/4g4dx72
Has FDA published a protocol to demonstrate bioequivalence between M, M and R & MMR?
No? Expect to wait 1 to 10 years. If a reliable bio-e trial couldn't be designed, would M, M and R need to be tested in 3 separate vaccine registration trials?
T.2 comes up with the dumbest stuff.
No? Expect to wait 1 to 10 years. If a reliable bio-e trial couldn't be designed, would M, M and R need to be tested in 3 separate vaccine registration trials?
T.2 comes up with the dumbest stuff.
August 10, 2026 at 10:51 PM
Has FDA published a protocol to demonstrate bioequivalence between M, M and R & MMR?
No? Expect to wait 1 to 10 years. If a reliable bio-e trial couldn't be designed, would M, M and R need to be tested in 3 separate vaccine registration trials?
T.2 comes up with the dumbest stuff.
No? Expect to wait 1 to 10 years. If a reliable bio-e trial couldn't be designed, would M, M and R need to be tested in 3 separate vaccine registration trials?
T.2 comes up with the dumbest stuff.
Combination of Zavegepant and Sumatriptan Considered a Safe Combination With Stable Pharmacokinetics
#MigraineChat
#MigraineChat
Combination of Zavegepant and Sumatriptan Considered a Safe Combination With Stable Pharmacokinetics
The pharmacokinetic exposure for both sumatriptan and zavegepant was comparable when coadministered, with all ratios remaining within the bioequivalence range of 80%-125%.
www.neurologylive.com
February 15, 2025 at 8:48 PM
Combination of Zavegepant and Sumatriptan Considered a Safe Combination With Stable Pharmacokinetics
#MigraineChat
#MigraineChat
Great article, interesting points about the impact of claim scope on generic/bioequivalence considerations, and risks associated with creating a patent prosecution record that doesn't match information provided to the FDA.
Patent Analysis: Lykos Suffers Blow from USPTO As All Patent Claims Stand Finally Rejected
The ailing MDMA drug developer faces another rejection, this time from the U.S. patent office.
Read more in this free issue of our Patent Analysis:
psychedelicalpha.com/news/patent-...
The ailing MDMA drug developer faces another rejection, this time from the U.S. patent office.
Read more in this free issue of our Patent Analysis:
psychedelicalpha.com/news/patent-...
Patent Analysis: Lykos Suffers Blow from USPTO As All Patent Claims Stand Finally Rejected - Psychedelic Alpha
The US Patent and Trademark Office has dealt a substantial blow to Lykos Therapeutics’ hopes of realising meaningful patent protection for its MDMA candidate, rejecting all of its claims as obvious.
psychedelicalpha.com
January 17, 2025 at 6:20 AM
Great article, interesting points about the impact of claim scope on generic/bioequivalence considerations, and risks associated with creating a patent prosecution record that doesn't match information provided to the FDA.
And if all else fails, lisdexamfetamine also comes in a chewable form; it is also generic now, but there are fewer manufacturers and I hear fewer people complaining about bioequivalence issues with it. (The really shit cheap generic manufacturers with horrible QC didn't enter that market.)
June 21, 2026 at 12:27 PM
And if all else fails, lisdexamfetamine also comes in a chewable form; it is also generic now, but there are fewer manufacturers and I hear fewer people complaining about bioequivalence issues with it. (The really shit cheap generic manufacturers with horrible QC didn't enter that market.)